Failure of Miniscrews

SYSTEMATIC REVIEW
Insertion torque and success of orthodontic mini-implants: A systematic review

Reint A. Meursinge Reynders,a Laura Ronchi,a Luisa Ladu,a,c Faridi van Etten-Jamaludin,b and Shandra Bipatc Milan, Italy, and Amsterdam, The Netherlands
Introduction: In this systematic review, we analyzed whether recommended maximum insertion torque values of 5 to 10 Ncm were associated with higher success rates of orthodontic mini-implants compared with miniimplants inserted with maximum insertion torque values beyond this range. Objective assessments of stability, variables that inuence maximum insertion torque values, and adverse effect of interventions were also assessed in the studies selected for our PICO (patient problem or population, intervention, comparison, and outcomes) question. Methods: Computerized and manual searches of the literature were conducted up to February 24, 2012, for human studies that assessed these objectives. Our eligibility criteria selected studies that (1) used sample sizes of 10 or more, (2) recorded maximum insertion torque during the insertion of orthodontic mini-implants, (3) inserted implants with a diameter smaller than 2.5 mm, and (4) applied orthodontic forces for a minimum duration of 4 months. Confounding was assessed through the analysis of risk of bias, and the validity of outcomes was rated according to the GRADE approach. The Cochrane Handbook for Systematic Reviews of Interventions was our main guideline for the methodology. Results: Seven nonrandomized studies met the eligibility criteria. All associations between specic maximum insertion torque values and success were based on literature rated as having low quality. The reasons for these judgments included subjective denitions of success, poor-quality torque sensors, and high risks for selection, performance, detection, and reporting biases. A risk of multiple publication bias was also suspected. All associations between maximum insertion torque and factors related to implant, patient, location, and surgery were rejected; few studies reported on adverse effects. Conclusions: Currently, no evidence indicates that specic maximum insertion torque levels are associated with higher success rates for orthodontic mini-implants. Additional research on this topic is therefore necessary. The following guidelines for future studies are suggested: (1) systematically review the animal and laboratory literature, (2) perform maximum insertion torque tests on articial bone, (3) test associations in animal studies before conducting clinical trials, (4) test associations between maximum insertion torque and the stability of orthodontic mini-implants with objective quantitative recordings rather than subjective qualitative measures, (5) measure maximum insertion torque with digital sensors rather than with mechanical devices, (6) assess the stability of orthodontic mini-implants at preestablished times, (7) consult our risk-of-bias analysis, and (8) analyze the adverse effects of interventions. (Am J Orthod Dentofacial Orthop 2012;142:596-614)
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any variables that affect the stability of orthodontic mini-implants (also called temporary anchorage devices) are still poorly understood.1-6 It has been suggested that excessive torque forces
Private practice, Milan, Italy. Clinical librarian, Medical Library of the Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. c Research associate, Departments of Radiology, Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. The authors report no commercial, proprietary, or nancial interest in the products or companies described in this article. Reprint requests to: Reint A. Meursinge Reynders, Via Matteo Bandello 15, 20123, Milan, Italy; e-mail, ortodonzia@fastwebnet.it. Submitted, October 2010; revised and accepted, June 2012. 0889-5406/$36.00 Copyright 2012 by the American Association of Orthodontists. http://dx.doi.org/10.1016/j.ajodo.2012.06.013
applied during the insertion of these devices can cause necrosis of the surrounding bone and compromise their success.2,7-9 It is therefore necessary to understand at what levels torque strains remain physiologic and can guarantee the stability of these implants. Finding reliable sources for stationary anchorage has long been a challenge for orthodontists. Orthodontic mini-implants have been introduced as promising solutions for this problem, but their outcomes are not always consistent.4,10 These devices can loosen, become mobile, or even migrate.5,11,12 Variables that inuence their success rates include factors related to patient, implant, location, surgery, orthodontics, and implant maintenance.10,13 This review will focus on insertion torque, which is a subgroup of surgery-related factors. Insertion torque results from frictional resistance between
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the screw thread and its surrounding bone and is a standard to evaluate mechanical stability.14-17 Maximum insertion torque is expressed in Newton centimeters (Ncm) and is the maximum torque value recorded during the insertion of orthodontic mini-implants. The stability of implants can be divided into primary and secondary. The former is mechanical stabilization achieved immediately after insertion, and the latter is attained when new bone forms at the implant interface.18 To achieve initial stability, a certain level of maximum insertion torque is necessary.2,19 Studies with dental implants have shown that increases in peak insertion torque can reduce the amount of micromotion and improve their success.18,20 However, excessive stress to the bone can cause necrosis and local ischemia7 and might impede osseointegration and hence secondary stability.2 Such an association was also suggested in various clinical studies in the orthodontic literature.2,21-24 Animal studies have associated higher maximum insertion torque values and overtightening of orthodontic mini-implants with fractures of the cortical bone.8,9 The orthopedic literature has shown that overtightening can damage and cause stripping of the bone, and this can lead to diminished holding strength25 with losses in pullout strength up to 40% to 50%.26 To control excessive stress during the insertion of orthodontic mini-implants, torque ratchets or torque sensors have been developed. Clinicians want to know whether specic maximum insertion torque values are associated with higher success rates. If a range of safe torque levels can be identied, they also want to learn which variables affect these measures. Maximum insertion torque values in the range of 5 to 10 Ncm have been presented as the gold standard in several clinical articles,2,21,22 and Google Scholar has recorded over 135 citations for one of these articles.2 However, conicting ndings on this issue have also been recorded in the orthodontic literature.24,27,28 Because of this disagreement and because currently no reviews have addressed these issues, a systematic review was deemed appropriate. The following PICO (patient problem or population, intervention, comparison, and outcomes) question was therefore asked: Is the application of maximum insertion torque values in the range of 5 to 10 Ncm (intervention) during the insertion of orthodontic mini-implants in patients who require maximum anchorage during treatment associated with higher success rates of orthodontic mini-implants (outcomes) than those inserted with maximum insertion torque values beyond this range (comparison)? Adverse effects of interventions and variables that inuence insertion torque levels were also assessed in the studies that were selected for our PICO question.
MATERIAL AND METHODS
The protocol for undertaking a systematic review is presented in a ow diagram (Fig 1), based on the Cochrane Handbook for Systematic Reviews of Interventions,29 and the CONSORT and PRISMA statements.30-33 To address the objectives of this review, we dened the selection criteria for the types of studies, interventions, outcomes, and timing of the results as follows. 1. Human studies with minimum samples sizes of 10 were considered. Animal studies, laboratory studies, technique articles, case reports, opinion papers, reviews, and in-vitro studies were excluded. Our preferred choice of research design was the randomized controlled trial, but nonrandomized studies with a low or moderate risk of bias were also assessed.34 This decision was based on the justications of the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions34 and the Centre for Evidence Based Medicine at the University of Oxford in the United Kingdom.35,36 The rationales for including nonrandomized studies in a systematic review are the following: (1) high-quality nonrandomized studies could produce a better unbiased effect size compared with low-quality randomized controlled trials; (2) randomized controlled trials could be unavailable for ethical reasons; (3) nonrandomized studies place the validity of the current literature in perspective and show the need for future research; (4) ndings of a review of nonrandomized studies might be helpful in designing subsequent studies; (5) nonrandomized studies could reveal potential unexpected or rare harms of interventions34,37; and (6) the validity of nonrandomized studies could be upgraded for demonstrating a large treatment effect.35,36 If moderate- or high-quality randomized controlled trials were identied, nonrandomized studies were not consulted for their treatment effect, but only for additional information on adverse effects of the intervention.34 Patients of either sex, in any ethnic, socioeconomic, or age group, and in any setting in need of stationary anchorage during treatment with xed orthodontic appliances were included. Interventions must include inserted orthodontic mini-implants for stationary orthodontic anchorage. Interventions must include records of the maximum insertion torque values during the insertion of orthodontic mini-implants. Maximum insertion torque represents primary stability and is dened
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American Journal of Orthodontics and Dentofacial Orthopedics
November 2012 Vol 142 Issue 5
598
Establish selection criteria
CRITERIA FOR CONSIDERING STUDIES
Establish search methods for identification of studies
Selection of studies
Present flow diagram searching for studies
SEARCHING FOR STUDIES
Establish what data to extract
Data extraction
Conduct subgroup analyses when indicated
Present estimate of effect for each outcome
DATA COLLECTION
Define types of bias specific for eligible studies
Define rating parameters for magnitude, reliability and direction of bias
Assess risk of bias across outcomes (only in case of multiple outcomes)
Assess risk of bias for outcomes within a study across domains
ASSESSMENT OF RISK OF BIAS FOR OUTCOMES
Define general parameters that can affect GRADE ratings
Initial quality assessment (GRADE)
Identify study specific factors that may affect the assessment of quality
Final quality assessment (GRADE)
SUMMARY OF FINDINGS TABLE FOR EACH ELIGIBLE STUDY
Fig 1. Flow diagram for a protocol of a systematic review.29-33
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as the maximum torque value recorded from the beginning to the end of the insertion process of orthodontic mini-implants.15 Maximum insertion torque is expressed in Newton centimeters and is recorded with either mechanical or electronic screwdrivers. Interventions must include insertion of orthodontic mini-implants with a diameter smaller than 2.5 mm. This limit was chosen because larger implants would not classify for specic orthodontic indications (eg, interradicular positioning). Articles on miniplates were excluded because of their different biomechanical characteristics. Studies that applied forces for more than 120 days were included.38 This arbitrary time frame was chosen because most orthodontic objectives cannot be completed in less than 4 months. Primary and secondary outcomes as well as adverse effects were assessed for the intervention under review. Eligibility was established irrespective of the outcomes measured or reported.39
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Success without mobility (score 0): implants with no clinically detectable mobility that could fulll all necessary orthodontic anchorage objectives. Success with mobility (score 1): implants that had become mobile but could still fulll all necessary orthodontic anchorage objectives. Success with displacement (score 2): implants that had become displaced but could still fulll all necessary orthodontic anchorage objectives. Not specied success (score NSS): the type of success of the implants was not specied and included scores of 0, 1, and 2.
Success was selected as the primary outcome for our question. The following characteristics were dened for this parameter. 1. An orthodontic mini-implant was considered successful when it could be loaded with orthodontic forces and fulll its anchorage objectives during a minimum period of 4 months. Orthodontic mini-implants that were lost or had become unusable were considered to be failures. This group also included implants that fractured at insertion or during orthodontic treatment. The timing for this outcome assessment was divided into 3 time frames: short term (4-6 months), medium term (6 months-1 year), and long term (1 year and longer).
The objective stability of orthodontic mini-implants was measured at their removal with mechanical or digital instruments. Values that were specic for each instrument were recorded: eg, removal torque or resonance frequency values. Variables that might inuence maximum insertion torque values of orthodontic mini-implants were classied under the following factors: implant, patient, location, and surgery. Associations between maximum insertion torque and these parameters were tested according to the following criteria: 1. An association with maximum insertion torque was only considered if it was based on samples sizes of 10 patients or more. A proposed association with maximum insertion torque was rejected when the article presented direct proof that at least 1 inuencing variable was not controlled. Lack of information about confounding factors was not sufcient to reject an association. Only associations that presented their P values and/or condence intervals were considered.
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One adverse effect, fractured implants, was also included as a primary outcome and expressed in ratios (number of fractured implants per total number of inserted implants). Three types of secondary outcomes were assessed: (1) subjective stability of the orthodontic mini-implants, (2) objective stability of the orthodontic mini-implants, and (3) variables that inuenced maximum insertion torque values. The stability of orthodontic mini-implants can be measured either subjectively by a clinician40 or objectively with various measuring devices.41,42 Immobility, mobility, and displacement were used as parameters to classify subjective stability and dened according to a recent systematic review.10
Adverse effects of insertion procedures of orthodontic mini-implants were assessed according to the guidelines in a recent systematic review.10 Adverse effects included implant fracture at insertion, biologic damage, inammation, and pain and discomfort. Biologic damage was dened according to the following parameters: 1. No biologic damage (score 0): no biologic damage had occurred, and no correcting dental procedures were considered necessary. Reversible biologic damage (score 1): biologic damage that is completely reversible with simple dental procedures. This group included removal of hyperplastic tissue and fractured orthodontic miniimplants that could be removed without causing irreversible damage.
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Irreversible biologic damage (score 2): biologic damage that is not completely reversible with simple dental procedures. This group included tooth, nerve, sinus, and blood vessel damage; fractured miniimplants that could not be removed; and the need for orthognathic surgery caused by uncontrolled biomechanics with orthodontic mini-implants. Not specied biologic damage (score NSBD): the biologic damage was described, but the type of damage was not identied. Postimplant biologic damage (score PIBD): the biologic damage was caused by treatment with orthodontic mini-implants but occurred or was detected after removal of the screw.
Inammation was measured either within the rst month of implant placement or beyond this time limit, and dened as follows: 1. No inammation: (score 0): no signs of inammation during the entire period of treatment with orthodontic mini-implants. Temporary inammation (score 1): inammation was conned to the rst month. Continuing inammation (score 2): inammation lasted longer than the rst month. Not specied inammation (score NSI): the duration of the inammation was not specied.
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Pain and discomfort were measured in the rst 2 weeks after implantation or beyond43 and dened as follows: 1. No pain or discomfort (score 0): no pain or discomfort during the entire treatment period with orthodontic mini-implants. Moderate pain or discomfort (score 1): moderate pain or discomfort noted in the rst 2 weeks. Severe pain or discomfort (score 2): severe pain or discomfort noted in the rst 2 weeks. Continuing pain or discomfort (score 3): pain lasting longer than 2 weeks. Not specied pain (score NSP): pain and discomfort were described, but their quality or duration were not specied.
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Search methods for identication of studies
To nd eligible studies for our PICO question, we consulted the following electronic data bases through February 24, 2012: Google Scholar Beta, PubMed (Medline), Embase (Ovid), CENTRAL, Science Direct, Scopus, Web of Science, LILACS, and AJOL.44-46 Eligible reports were also searched in the grey literature, because excluding those data bases could introduce publication bias.47 For this purpose, we consulted Open Grey, the Health Management Information
Consortium (HMIC), and the National Technical Information Service (NTIS). The fourth author (F.E.J.), a librarian who specializes in computerized searches of health science publications at the Academic Medical Centre of the University of Amsterdam, assisted with the examination of these databases. Transparency and reproducibility of our search process was our primary goal, and we aimed for high sensitivity and accepted low precision.44 To avoid inappropriate exclusion, a wide variety of search terms was combined, including the following subject headings and keywords: orthodontics, torque, implant, mini implant, micro implant, microimplant, screw, mini screw, miniscrew, micro screw, microscrew, and temporary anchorage device. For each search engine, the appropriate characters were used to truncate or explore the search terms. Nouns, adjectival, and singular and plural forms of all keywords were inserted.44 Search lters were avoided, and the Boolean NOT operator was not applied.44 To analyze whether the keywords had covered all articles on orthodontic mini-implants, the following journals were handsearched: American Journal of Orthodontics & Dentofacial Orthopedics, Angle Orthodontist, European Journal of Orthodontics, Journal of Orthodontics, Journal of Clinical Orthodontics, Seminars in Orthodontics, World Journal of Orthodontics, and International Journal of Adult Orthodontics and Orthognathic Surgery. In addition, the references in each identied article were manually screened for articles that possibly were missed by the electronic search engines. All manual and electronic searches were solicited for review articles, and references found in these reviews were screened for relevant articles.44 No language restrictions were applied in the search strategy, and pertinent articles were translated and reviewed. To minimize the risk of missing eligible studies, 3 authors (R.A.M.R., L.R., L.L.), all topic experts, selected the studies.47,48 All selection procedures were performed independently by these reviewers. The fth author (S.B.) guaranteed the soundness of the methodology and the statistics of this study. To control interexaminer agreement (kappa statistics), we followed the protocol in the Cochrane Handbook for Systematic Reviews of Interventions.47 According to this protocol, pilot tests on samples of reports were used to rene and clarify the eligibility criteria and ensure that these criteria could be applied consistently.47 Then, all titles and abstracts were examined to remove obviously irrelevant reports. The full texts of potentially relevant articles were retrieved and reviewed. Ambiguous articles were also read to prevent inappropriate exclusions. To avoid bias through duplicate publications, special attention was paid to identifying multiple reports from the same study.47 In case of
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Records identified through database searching (n = 9464)
Additional records identified through other sources (n =16)
Records screened ( n =9480)
Records excluded (n =9443)
Full-text articles assessed for eligibility ( n= 37)
Full-text articles excluded, with reasons (n= 30)
Studies included in qualitative synthesis ( n=7 )
Fig 2. PRISMA ow diagram.32,33
uncertainties, the authors of such articles were contacted for clarication. Disagreements between authors about the eligibility of articles were resolved by rereading and discussion. Our selection procedures are presented in a ow diagram (Fig 2). Prior to conducting this systematic review, data collection forms were designed and pilot tested for their validity. These forms included all information about a study: eg, details of methods, participants, settings, contexts, interventions, outcomes, variables, results, publications, and investigators.47 Although orthodontics and implant-related factors do not inuence insertion torque values, they were recorded because they can inuence success rates. Data that could facilitate the assessment of risk of bias were also collected. Data extraction procedures were done independently by all 3 topic experts. Disagreements between authors were resolved by rereading and discussion. Investigators of the selected studies were contacted in case of uncertainty or inability to extract all necessary information, or in case of disagreement between reviewers.47 If possible, individual patient data were sought directly from the authors.47 Subgroup analyses were performed only if the study itself or the individual patient data provided sufcient data to permit such assessments.49
The validity of each study was scored through the assessment of risk of bias in the results.50 Critical judgments were made for the following domains: multiple publications, selection, performance, detection, attrition, and reporting bias. Performance bias was further subdivided as implant, location, surgery, orthodontics, implant maintenance, outcome assessment, operator, and duration related systematic errors. To guarantee the transparency of these judgments, detailed information on these variables was presented. Judgments were made on the magnitude, reliability, and direction of bias. Descriptions and denitions of each type of bias are given in Table I. Judgments were dened as low, high, or unclear risk of bias. The Cochrane Collaboration50 assigns the latter score if 1) insufcient detail is reported of what happened in the study; 2) what happened in the study is known, but the risk of bias is unknown; 3) an entry is not relevant to the study at hand. Domains of bias were scored as high risk only when the article presented direct evidence that an entry was at risk of systematic error. Incorporating assessments of risk of bias was not used as a threshold for inclusion of studies but exclusively as a possible explanation for differences in results. For the assessment of the quality of a body of evidence, we applied the GRADE approach,51 which was
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Table I. Classication scheme for the assessment of risk of bias in maximum insertion torque studies
Type of bias Multiple publication bias Selection bias Performance bias, implants Performance bias, patients Performance bias, location Performance bias, surgery
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Performance bias, orthodontics
Performance bias, implant maintenance
Performance bias, outcome assessment Performance bias, operator Performance bias, duration Detection bias assessors Attrition bias Reporting bias
Description of bias Judgment on duplicate or multiple publications of the same research. Judgment on the type of sample selection concerning random sequence generation, allocation concealment, and description of sample characteristics on outcomes. Judgment on the impact of, eg, the description, quality, and other implant-related confounding factors on outcomes. Judgment on the impact of, eg, the number, age, physical, dental status, and other human-related confounding factors on outcomes. Judgment on the impact of, eg, the site of insertion, character of the mucosa, exposure, and other location-related confounding factors on outcomes. Judgment on the impact of, eg, the torquing device, ap/apless technique, distance between screws, direction and speed of insertion, time of insertion torque assessment, self-drilling/ predrilling insertion technique, starter and full-length pilot holes, depth of insertion, axial load, stripping, and other surgery-related confounding factors on outcomes. Judgment on the impact of, eg, the type of orthodontic movement, timing and duration of force application, the magnitude, type, and direction of the force, and other orthodontics-related confounding factors on outcomes. Judgment on the impact of, eg, protocols for antibiotics, chlorhexidine rinses, oral hygiene, control of peri-implantitis and mobility, and other implant maintenance-related confounding factors on outcomes. Judgment on the character and quality of outcome assessments: eg, subjective or objective methods of assessments on outcomes. Judgment on the impact of operators concerning blinding on outcomes. Judgment on the duration of the intervention concerning a precise description of the duration of the study on outcomes. Judgment on the impact of assessors concerning blinding on outcomes. Judgment on the impact of incomplete outcome data concerning completeness of sample, follow-up, and data on outcomes. Judgment on the impact of the type of reporting concerning selective or incorrect reporting on outcomes.
also adopted by the Cochrane Collaboration.52 According to this grading systems, 4 levels of quality (high, moderate, low, and very low) were scored for individual outcomes. Factors that could decrease the quality of a body of evidence included limitations in the design of the selected studies, high risk of bias, indirectness of evidence, unexplained heterogeneity, imprecision of results, unit of analysis issues, and high probability of publication bias.35,36,49,52-55 Factors that could upgrade the body of evidence included a large treatment effect, or when all biases would affect the magnitude of a treatment effect in the same direction.51,52,54 We only considered outcomes of high or moderate quality. Risk ratio and odds ratio were chosen as measures for our dichotomous primary outcomes. If indicated, unit of analysis issues were assessed according to the level at which randomization occurs and analyzed for each design.49
Statistical analysis
eligible studies, (2) consistent effect sizes (treatment effect) across the range of studies, (3) low reporting bias, (4) a high number of eligible studies, and (5) low heterogeneity between studies.49,50,53 Funnel plots were designed to detect reporting biases. Funnel asymmetry was assessed only when at least 10 eligible articles were identied because, with fewer studies, the power of this test is too low to distinguish chance from real asymmetry.46
RESULTS
The criteria for a meta-analysis of the summary effect size are shown in a ow diagram (Fig 3). Such a synthesis was conducted in the case of (1) low risk of bias in
A ow diagram according to the PRISMA group was used to explain the selection procedures (Fig 2).30,32,33 No interexaminer disagreement was recorded for the inclusion of studies, indicating a kappa of 1.0. The various search methods for identication of studies found a total of 9480 abstracts with overlap (Appendix Table I). Thirty-seven full-text articles were assessed for eligibility; 30 were excluded. The reasons for exclusion are listed in Appendix Table II.47 The characteristics of the selected studies are summarized in Table II. All articles were nonrandomized cohorts,2,21-24,27,28 and 4 of the 7 articles were published by the same research group.2,21-23
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Define criteria for justifying a meta-analysis of a summary effect: a) b) c) d) e) Low risk of bias in studies (high or moderate quality (GRADE) Consistent effect size across studies Low reporting bias A high number of studies Low heterogeneity between studies Assess criteria a-e prior to undertaking a meta-analysis
JUSTIFYING A META-ANALYSIS
Calculate the appropriate effect measures of the intervention for each study
Calculate the weight average of the intervention effect of all studies
Assess whether to conduct a fixed-effects or a randomeffects meta-analysis or both
UNDERTAKING A META-ANALYSIS
Assess criteria a,b,c and d
Assess heterogeneity (e) and when indicated conduct subgroup analyses and metaregressions
Conduct sensitivity analyses to assess the effects of procedural decisions on findings
Define general parameters that can affect GRADE ratings
Initial quality assessment (GRADE)
Identify study specific factors that could affect the assessment of quality
Final quality assessment (GRADE) of the metaanalysis
ASSESSING THE VALIDITY OF A BODY OF EVIDENCE SUMMARIZED IN A META-ANALYSIS
SUMMARY OF FINDINGS OF ALL STUDIES (FOREST PLOTS) AND ADDITIONAL TABLES AND FIGURES
Fig 3. Flow diagram for a protocol of a meta-analysis of the summary effect size.49,50,53
High heterogeneity was found between and within the selected articles, and large standard deviations were recorded for the maximum insertion torque values (Table II). In most studies, the implants were inserted in poorly dened locations, various types of screws were
used, and different surgical and orthodontic techniques were applied (Appendix Tables III-IX). Tests for funnel plot asymmetry were not indicated because only 7 eligible studies were identied.46 Most studies measured maximum insertion torque with mechanical torque
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Table II. Characteristics of maximum insertion torque studies

Authors and year of publication Motoyoshi et al2 2006 Design of study Nonrandomized cohort Patients (n) 41 Implant numbers, types, and characteristics 124 Biodent (tapered) D 1.6 mm L 8 mm 169 Biodent (tapered) D 1.6 mm L 8 mm
Motoyoshi et al21 2007
Nonrandomized cohort
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Arismendi et al27 2007
Chaddad et al24 2008
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Suzuki and Suzuki28 2011
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87 Biodent (tapered) D 1.6 mm L 8 mm 34 Leone (cylindrical) D 1.5 and 2.0 mm L 10.0 and 12 mm 17 Dual Top (machined and tapered) D 1.4, 1.6, and 2.0 mm L 6.0, 8.0, and 10.0 mm 15 C implants (sandblasted and tapered) D 1.8 mm L 8.5 mm 134 Biodent (tapered) D 1.6 mm L 8 mm 120 Sistema Nacional de Implantes (cylindrical) D 1.5 mm, L 6 and 8 mm 160 ACR (tapered) D 1.5 mm, L 6 and 8 mm
MIT, Maximum insertion torque; D, diameter of the screw; L, length of the screw; PDI, predrilling insertion technique; SDI, self-drilling insertion technique.
sensors (Table III), but these devices cannot record insertion torque during the entire insertion process. The curves of insertion torque vs time were therefore not available, and possible stripping of the bone could not be analyzed. Suzuki and Suzuki28 used a digital torque sensor but measured maximum insertion torque only at the nal turn of the screwdriver. Success rates ranged from averages of 55.6% to 100%, depending on the subgroup, but the timing of these assessments varied widely. These rates were based on a wide variety of subjective denitions of stability. Objective stability of orthodontic mini-implants was assessed in 3 studies23,27,28 (Table III). Two of these studies recorded removal torque values,23,28 and 1 study measured stability with digital calipers.27 The risk of bias analysis was conducted with rigorous precision, because the magnitude and direction of bias is generally higher in nonrandomized studies than in randomized trials.34 All studies had 2 or more domains
scored as high risk of bias (Table IV). This score was applied to selection bias in the 7 eligible studies, because all were nonrandomized studies. High-risk scores for performance bias were also identied in all articles. This type of systematic error is specied in Table V, and additional explanations for these judgments can be veried in Appendix Tables III through IX. Four of the 7 selected articles were published by Motoyoshi et al2,2123 (Table II). Various letters were sent to these authors in 2010, 2011, and 2012 to inquire about individual patient data and the potential overlap of studies, but they did not reply. The domain multiple publication bias for these studies was therefore scored as an unclear risk of systematic error (Table IV). Associations between maximum insertion torque and success are summarized in Table VI. Most of these assessments were based on subjective denitions of success. Chaddad et al24 found higher success rates at torque values above 15 Ncm, and 3 studies by Motoyoshi
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Table II. Continued

Implant sites Posterior buccal alveolar bone in maxilla and mandible Posterior buccal alveolar bone in maxilla and mandible Insertion technique PDI MIT Maxilla: 8.3 6 3.3 Ncm Mandible: 10 6 3.3 Ncm Adolescent, early load: Maxilla: 8.9 6 2.6 Ncm Mandible: 8.5 6 3.0 Ncm Adolescent, late load: Maxilla: 7.6 6 2.7 Ncm Mandible: 8.8 6 3.0 Ncm Adult, early load: Maxilla: 8.8 6 2.8 Ncm Mandible : 8.8 6 2.6 Ncm Success group: 8.83 6 2.83 Ncm Failure group: 9.64 6 6.62 Ncm Range, 11-25 Ncm
PDI
Posterior buccal alveolar bone in maxilla and mandible Buccal alveolar bone in maxilla and palatal bone
PDI
PDI
Posterior buccal alveolar bone in maxilla and mandible
SDI
Torquing device set at 15 Ncm
Posterior buccal alveolar bone in maxilla and mandible Alveolar bone in maxilla and mandible and in midpalatal suture area
PDI
Maxilla: 7.67 6 2.62 Ncm Mandible: 8.40 6 2.51 Ncm PDI maxilla: 7.2 6 1.4 Ncm PDI palate : 14.5 6 1.6 Ncm PDI mandible: 12.4 6 1.2 Ncm SDI maxilla: 12.1 6 3.1 Ncm SDI palate: 21.1 6 2.2 Ncm SDI mandible: 15.7 6 2.3 Ncm
PDI SDI
et al2,21,23 recommended placement torques between 5 and 10 Ncm. Three other articles could not associate specic maximum insertion torque with the stability of orthodontic mini-implants.23,27,28 The quality of the body of evidence for all associations was rated as low according to the GRADE approach (Table VI). Complete interexaminer agreement was recorded for these quality readings. Risk ratios were not calculated, and data were not pooled to conduct a meta-analysis of the summary effect size, because of high heterogeneity, inconsistent effect sizes, and high risk of bias across the studies (Fig 3). Table VII summarizes variables associated with maximum insertion torque levels. Many contrary associations were presented for the same variable, but all 20 proposed associations were rejected because of confounding. Ten associations were excluded because bone drills had modied insertion torque values to preestablished levels, thereby skewing the outcomes of the variables under review. Adverse effects are listed in Table
VIII. Inammation of soft tissues was recorded in 2 articles24,27; 1 article reported 1 implant fracture during insertion and 4 during the removal of the orthodontic mini-implants.28
DISCUSSION
Variables that affect the stability of orthodontic mini-implants are both numerous and heterogeneous; this makes reviewing difcult.10 In this systematic review we extracted just 1 factor (maximum insertion torque) to make it more narrow in scope and therefore more wieldy. To identify eligible studies, special measures were applied that minimized the risk of introducing publication, location, language, and multiple publication bias. These precautions implied that (1) a wide spectrum of keywords, search engines, and grey literature was consulted; (2) 3 investigators were involved; (3) no language restrictions were applied; and (4) authors were contacted in
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case of uncertainties about multiple publications from 1 study.46 These selection procedures identied only nonrandomized studies. Although systematic reviews focus particularly on randomized controlled trials,56 the inclusion of nonrandomized studies could be justied for the following reasons: 1. High-quality nonrandomized studies could produce a less biased estimate of effect size compared with low-quality randomized controlled trials.53 Systematic reviews of nonrandomized studies can demonstrate areas where the available evidence is insufcient and explain the need of subsequent research.34,57 They can further help to improve on the design of future trials through the identication of relevant subgroups.34 Etiologic hypotheses can generally not be tested in randomized experiments58 and could easily be opposed for ethical reasons.34 To answer our PICO question, patients should ideally be assigned to 1 of 2 (or more) alternative forms of treatment. This would entail, for example, predrilling implant sites to create pilot holes with different dimensions. Such protocols would establish groups with different preestablished maximum insertion torque values but are difcult to obtain approval by ethics review boards.44 Systematic reviews of nonrandomized studies can put citation bias in perspective. Citation metrics indicate the signicance of impact of a particular study in its eld.59 At the time of writing this systematic review, Google Scholar Beta registered over 135 citations for 1 selected article, which recommended specic safe insertion torque values for orthodontic mini-implants.2 This was surprising because of the high scores of bias and low quality ratings of this article (Tables IV-VI). This systematic review could therefore have an important role in preventing citation and publication bias. Including nonrandomized studies could provide additional information regarding potential adverse effects, because many serious harms of interventions are unexpected or rare and do not appear during the period of study of a randomized controlled trial. The level of evidence of nonrandomized studies can be upgraded for demonstrating large effects.35,36 This criterion could not be applied, because no selected study had such an outcome.
2.
3.
4.
5.
evidence to support this hypothesis. This nding was conrmed by studies that assessed a possible association between specic maximum insertion torque values and objective measures of stability.23,27,28 Three studies found a positive answer to our PICO question,2,21,22 but opposing outcomes were also recorded by other research groups.24,28 This heterogeneity was caused by 3 factors: (1) differences in materials and methods between studies (Tables II and III; Appendix Tables IIIIX), (2) different denitions of success and stability, and (3) lack of control of confounding factors and therefore high risk of systematic error for various domains (Tables IV and V). The assessment of risk of bias is considered the cornerstone of a systematic review and was therefore used as a framework to explain conicting outcomes. We recommend consulting the following analysis for the design of future trials for this PICO question. The inclusion of several publications of a single study could lead to overestimation of the effects of an intervention.46 Four studies appeared to be almost identical.2,21,23 Their authors were frequently contacted in 2010, 2011, and 2012 but did not respond to our correspondence. Because we had no direct proof that these articles represented 1 study, the relatively mild unclear risk of bias score was assigned (Table IV). Susceptibility to selection bias is the principal difference between randomized trials and nonrandomized studies.34 No information on selection procedures was presented in the eligible articles, and the risk of heterogeneous sampling and cherry-picking was therefore high. Samples had disproportionate divisions of the sexes, with more female subjects and a wide range of ages (Appendix Table IV). Eight subdivisions of performance bias were identied. All selected studies scored at least 3 of these entries as high risk of bias (Table V). Confounding factors included the following: 1. 2. 3. Grouping of implants of different types and dimensions24,27 (Appendix Table III). Heterogeneous sites of insertion of orthodontic mini-implants (Appendix Table V). Uncontrolled surgery-related factors (Appendix Tables VI and VII). Different torque sensors were used in the selected studies, and no information on the calibration of these devices was presented. Most studies measured maximum insertion torque values with mechanical torque drivers. Recordings with these devices are subject to error, because axial load and the position and posture of the clinician can affect their readings.15 Also, they lack precision and can be damaged over time during the sterilization process.60 Furthermore, mechanical
6.
7.
It was hypothesized that maximum insertion torque values of 5 to 10 Ncm were associated with higher success rates of orthodontic mini-implants. We found no
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Table III. Success and stability in maximum insertion torque studies

Authors Motoyoshi et al2 Motoyoshi et al21 Torquing device Mechanical Mechanical Time of success measurement 6 months or more 6 months or more Success rate and subjective stability of OMIs 85.5% (score NSS) Early load, adolescents: 63.8% (score 0); range: 55.6%-71.4% Late load, adolescents: 97.2% (score 0); range: 90.9%-100% Early load, adults: 91.9% (score 0); range: 85%-100% Success rates combined: 85.2% (score 0); range: 55.6%-100% 87.4% (score 0); range: 85.7%-90.9 % 97.1% (score 1) Objective stability of OMIs ND ND
Motoyoshi et al22 Arismendi et al27
Mechanical ND
6 months or more Mean, 6.5 months Range, 3-9 months 150 days
ND Mobility of 0.6 mm or more: At 3 months: 3% of OMIs At 8 months: 13.6% of OMIs ND
Chaddad et al24
Mechanical
Motoyoshi et al23
Mechanical
Mean, 23.1 6 6.7 months 44 6 11 weeks
Machined implants: 82.5% (score 0) Surface treated: 93.5% (score 0) Success rates combined 87.5% (score 0) 90.45% (score 1)
Suzuki and Suzuki28
Digital
Predrilling group, 94.16% (NSS) Self-drilling group, 92.5% (NSS)
Removal torque: Maxilla: 4.37 6 2.20 Ncm Mandible: 4.09 6 1.90 Ncm Removal torque: 15.8 6 3.6 to 26.9 6 2.0 Ncm
Subjective stability: score 0, success without mobility; score 1, success with mobility; score 2, success with displacement; NSS, not specied success (includes scores 0-2). OMIs, Orthodontic mini-implants; ND, not described.
Table IV. Risk of bias in maximum insertion torque studies

Authors Motoyoshi et al2 Motoyoshi et al21 Motoyoshi et al22 Arismendi et al27 Chaddad et al24 Motoyoshi et al23 Suzuki and Suzuki28 Multiple publication bias Unclear Unclear Unclear Low Low Unclear Low Selection bias High High High High High High High
34,47,50
Performance bias High High High High High High High
Detection bias Unclear Unclear High Unclear High Unclear High
Attrition bias Unclear Unclear Unclear Low Unclear Low Low
Reporting bias Low High High Low Low High High
Unclear: The Cochrane Collaboration50 assigns the latter score if 1) insufcient detail is reported of what happened in the study; 2) what happened in the study is known, but the risk of bias is unknown; 3) an entry is not relevant to the study at hand.
Table V. Risk of performance bias in maximum insertion torque studies

Implantrelated bias Low Low Low High High Low Low Locationrelated bias High High High High High High High Surgeryrelated bias High High High High High High High Orthodonticsrelated bias Unclear Unclear Unclear High High Unclear Unclear
34,47,50
Authors Motoyoshi et al2 Motoyoshi et al21 Motoyoshi et al22 Arismendi et al27 Chaddad et al24 Motoyoshi et al23 Suzuki and Suzuki28
Implant maintenancerelated bias Unclear Unclear Unclear Unclear Unclear Unclear Unclear
Outcome assessmentrelated bias High High High Low High Unclear Unclear
Operatorrelated bias Unclear Unclear Unclear Low High Unclear Unclear
Durationrelated bias High High High High Low High High
Unclear: The Cochrane Collaboration50 assigns unclear risk of bias if 1) insufcient detail is reported of what happened in the study; 2) what happened in the study is known, but the risk of bias is unknown; 3) an entry is not relevant to the study at hand.
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Table VI. Summary of ndings of associations between maximum insertion torque and success or stability
Association between MIT and success and character of statistical signicance Mandible: MIT 5-10 Ncm higher success rates than MIT .10*or \5 Ncm (NS) Maxilla: MIT 5-10 Ncm higher success rates than MIT .10* or \5 Ncm* Adolescent, early load: MIT 5-10 Ncm higher success rates than MIT .10* or \5 Ncm* in the maxilla, with no differences in the mandible, and the sum of maxilla and mandible combined Adolescent, late load: Association between success rates and MIT was not analyzed, because of high success rates Adult, early load: MIT 5-10 Ncm higher success rates than MIT .10 Ncm in the maxilla,* and the sum of maxilla and mandible combined* MIT 8-10 Ncm higher success rates than implants with MIT .10*or \8 Ncm* No association between MIT and stability of OMIs MIT .15 Ncm higher success rates than MIT \15 Ncm* No signicant correlation between MIT and removal torque No signicant difference in MIT values between successful and failed OMIs in both PDI and SDI groups (NS) Studies proposing this association Motoyoshi et al2 Quality (GRADE) Low
Motoyoshi et al21
Low
Motoyoshi et al22 Arismendi et al27 Chaddad et al24 Motoyoshi et al23 Suzuki and Suzuki28
Low Low Low Low Low
MIT, Maximum insertion torque; OMIs, orthodontic mini-implants; PDI, predrilling insertion technique; SDI, self-drilling insertion technique; NS, not signicantly different. *P \0.05.
4.
5. 6.
torque drivers record only 1 insertion torque value at the nal rotation of the screw and cannot register intermediate torque values during the insertion of orthordontic mini-implants. Information on possible stripping of the bone was therefore lacking. Stripping of bone threads reduces the pullout strength of screws by 40% or more and therefore signicantly affects their holding power.25,26 Digital torque sensors, on the other hand, can present a graph of the insertion torque values during the entire insertion procedure and provide immediate information when stripping occurs. Based on this information, the surgeon can decide to change the length or the diameter of the screw, place the screw in another location, or modify the loading protocol. Lack of homogeneity in the orthodontic protocols (Appendix Table VIII). Precise descriptions of the type of orthodontic movement, timing of force application, magnitude, type, duration, and direction of orthodontic forces were often lacking. Poorly dened implant maintenance protocols. The outcome assessments were subjective (Table III). Subjective judgments of successeg, rated by at least 1 clinicianwere presented in most of the studies and can introduce bias. To prevent confusion in future studies, we propose distinguishing between success and stability of orthodontic mini-implants. The former parameter should be de-
7.
8.
ned as the ability of a mini-implant to fulll all preestablished anchorage objectives and should be registered at the completion of these goals. Success should not be used for testing associations with independent variables because treatment objectives in orthodontics are rarely completed under the same conditions and within the same time intervals. Furthermore, success is a qualitative subjective measure and therefore less reliable. Stability, on the other hand, is an objective quantitative value that can be recorded with objective measuring devices, eg, periotest,61,62 resonance frequency analysis,63,64 removal torque recordings,15,23 or pullout tests65 (the latter is not feasible in human subjects). Most of these tests can be conducted at preset times and are not conditioned by the duration of a particular treatment. It has been shown that orthodontic and mini-implants osseointegrate,8,9,28,66,67 information on objective stability at different times could help clinicians with the application of appropriate loading protocols. Lack of clarity about blinding of the operators (Table V). Operator-related bias was rated as unclear for most studies. This parameter was not considered in our quality rating, because blinding during surgical procedures is generally difcult to accomplish. The duration of the application of forces varied widely and was often poorly dened (Table III). Assessments of success at random times could
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Table VII. Summary of ndings of variables associated with maximum insertion torque
Association with MIT Implant-related factors Same MIT in machined and surface treated screws (NS) Patient-related factors MIT and sex: no Higher MIT with increasing age* MIT and age: no Location-related factors Same MIT on left and right sided in the success group (NS) Same MIT on left and right sided (NS) Same MIT on left and right sided (NS) Higher MIT with increasing cortical bone thickness in maxilla* Higher MIT with increasing cortical bone thickness for the maxilla and mandible combinedy MIT and cortical bone thickness in mandible: no Higher MIT in mandible than maxillay Higher MIT in mandible than maxilla* Same MIT in maxilla and mandible Same MIT in maxilla and mandible Higher MIT on palatal side compared with buccal side* Higher MIT in midpalatal suture than in dentoalveolar area in maxilla in the predrilling and self-drilling groups* Higher MIT in the dentoalveolar area in the mandible than in the maxilla in the predrilling and self-drilling groups* No difference in MIT values between the mandible and midpalatal suture in the predrilling group (NS) Higher MIT in midpalatal suture than in mandible in the self-drilling group* Surgery-related factors Higher MIT in self-drilling insertion group compared with the predrilling insertion groupz Total Studies proposing association with MIT Chaddad et al24 Motoyoshi et al23 Motoyoshi et al23 Motoyoshi et al21 Motoyoshi et al2 Motoyoshi et al21 Motoyoshi et al23 Motoyoshi et al23 Motoyoshi et al22 Motoyoshi et al23 Motoyoshi et al2 Motoyoshi et al22 Motoyoshi et al21 Motoyoshi et al23 Arismendi et al27 Suzuki and Suzuki28 Suzuki and Suzuki28 Suzuki and Suzuki28 Suzuki and Suzuki28 Suzuki and Suzuki28 20 associations Rejected associations and reasons for rejection Rejected (a,b,c,d) Rejected (c,d,e) Rejected (c,d,e) Rejected (d,e) Rejected (c,d) Rejected (d,e) Rejected (c,d,e) Rejected (c,d,e) Rejected (c,d) Rejected (c,d,e) Rejected (c,d) Rejected (c,d) Rejected (d,e) Rejected (c,d,e) Rejected (a,b,c,e) Rejected (b,c,d) Rejected (c,d) Rejected (b,c,d) Rejected (b,c,d) Rejected (c,d) 20 rejected
MIT, Maximum insertion torque; NS, not signicantly different. Rejection criteria: a, number of implants \10; b, implant-related factors were not controlled; c, patient-related factors were not controlled; d, location-related factors were not controlled; e, bone drills had modied MIT values to preestablished levels. *P \0.05; yP \0.01; zP \0.001.
Table VIII. Adverse effects of inserting orthodontic mini-implants in maximum insertion torque studies
Authors Motoyoshi et al2 Motoyoshi et al21 Motoyoshi et al22 Arismendi et al27 Chaddad et al24 Motoyoshi et al23 Suzuki and Suzuki28 Implant fracture ND ND ND ND ND ND 1 during insertion and 4 during removal of implants on a total of 280 implants Biologic damage ND ND ND ND ND ND ND Inammation ND ND ND 32.3% (score 2) entire treatment period 6.25% (score 1) (for 14 days) 6.25% (score 2) (for 85 days) ND ND Pain and discomfort ND ND ND ND 20% (score 1) ND ND
ND, Not described. Inammation: score 1, temporary inammation; score 2, continuing inammation. Pain and discomfort: score 1, moderate pain and discomfort.
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introduce an additional variable because osseointegration of implants is time-dependent; studies that are stopped at random time intervals could underestimate or overestimate the effects of interventions50; and certain types of adverse effects, such as root resorption, can be missed in the case of early stopping.50 Although blinding of operators during surgical procedures is difcult to accomplish, masking of outcome assessors is relatively simple, because success can be measured by an operator not familiar with the objectives of the study. Most selected articles, however, scored unclear or with a high risk for detection bias. Incomplete outcome data, due to attrition (fracture of implants or dropouts), raise the possibility that an observed effect is biased.50 It is important to consider both the missing data and the reasons for the missing data.50 Attrition bias was rated as unclear in 4 studies (Table IV). Selective reporting indicates that certain outcomes on the basis of their results are included or withheld from publication.50 One article presented only success rates for specic maximum insertion torque values without reporting the number of implants.21 Two articles did not specify the recommended maximum insertion torque values separately for each jaw22,28; in another article, the numbers did not add up.23 These 4 articles were therefore rated as having a high risk of reporting bias (Table IV). Variables that inuence maximum insertion torque values were divided into implant-, patient-, location-, and surgery-related factors (Table VII). Rejection criteria were discussed according to these categories. Animal and laboratory studies were consulted to compare ndings. Chaddad et al24 found no differences in maximum insertion torque levels in machined screws compared with surface-treated screws. This association was rejected, because confounding factors were poorly controlled (Table VII). Animal studies on implant-related factors have shown that the surface treatment,15 form,4,8 and diameter8 of orthodontic mini-implants were associated with maximum insertion torque values. These ndings have been conrmed in laboratory studies on animal and articial bone and have important implications.16,42,68 Small changes in 1 variable could cause excessive bone strains or insufcient holding power. This was conrmed by tomographic and histomorphometric analyses in an animal study in which greater microdamage was registered: cortical bone cracks, when orthodontic mini-implants with larger diameters and tapered shapes were inserted.8
Sex, age, and physical and dental statuses are part of this group of variables. Motoyoshi et al23 found signicantly higher maximum insertion torque values with increasing age. This was expected, because bone densities in adolescents are lower than those of young adults. However, in another article from the same research group, no differences in maximum insertion torque values were recorded between age groups (Table VII).21 These opposing associations were both rejected, because variables related to patient and location were not controlled. In addition, insertion torque values were adjusted with bone drills to preestablished torque levels. These procedures jeopardized an unbiased assessment of a possible association between insertion torque and age. A proposed association between maximum insertion torque and sex was rejected for similar reasons.23 Differences in sex should be considered because cortical bone thickness can vary between the sexes.69 Left and right differences, cortical bone thickness, and various insertion sites in the maxilla and mandible were assessed for associations with specic maximum insertion torque levels. All associations between maximum insertion torque and location-related factors were rejected because of confounding. Many of these associations had opposing outcomes; this explains the poor control of confounding factors and possibly the lack of homogeneity of implant site selection within and between studies. Precise identication of these sites is essential because cortical bone thickness can even vary according to the distance from the alveolar crest.69 Animal studies have shown higher maximum insertion torque values in the mandible compared with the maxilla, and higher recordings were also registered with increasing cortical bone thickness.4,15,70 These associations require further conrmation from carefully designed articial bone and animal studies. Animal studies have shown that predrilling or selfdrilling surgical techniques and the diameter of the pilot hole can signicantly inuence maximum insertion torque values.70,71 By modifying these variables, clinicians can insert orthodontic mini-implants with desired maximum insertion torque levels and thereby obtain appropriate primary stability in sites with either stiff or fragile bone. Surgical procedures can also be modied to lower insertion torque values to prevent fractures of orthodontic mini-implants.72 Only 1 surgery-related association with maximum insertion torque was presented, but it was rejected because of confounding (Table VII). Adverse effects of insertion of orthodontic miniimplants were assessed in only 3 studies. To achieve a balanced perspective, assessments of both primary and negative outcomes of interventions are necessary.73
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Denitions of adverse outcomes and their intensities should be precisely recorded because they can vary across studies.47 Adverse effects were assessed according to the guidelines of a recent systematic review10; we recommend this framework for future articles. Follow-up studies of adverse outcomes of interventions are also necessary for the assessment of the long-term consequences of root and nerve damage, or sinus and nasal cavity perforations, for example. Before authors set up a randomized controlled trial, we suggest that they adopt rigorous research protocols with the following sequence: 1. Systematically review the laboratory and animal literature to assess how implant-, location-, or surgery-related factors inuence maximum insertion torque. If these reviews provide insufcient answers, each factor should be isolated and tested for its effect on maximum insertion torque values and therefore primary stability. Most of this initial research can be conducted on laboratory models. Articial bone would be the material of choice, because it has similar mechanical properties as human cancellous bone but is more homogeneous.74 ASTM International has therefore chosen polyurethane foams for testing insertion torque of medical bone screws.74 When a good understanding of the variables that inuence primary stability is obtained, specic maximum insertion torque values can be tested for secondary stability in animal studies. In a subsequent phase, the effect of loading vs nonloading and other orthodontic-related factors can be investigated.
also necessary. These rates and their timings can provide important information on initial and secondary stability, because there is currently no consensus on whether or when an interface between the bone and the orthodontic mini-implant has formed.75 To achieve a balanced perspective, adverse effects should be scored and handled with the same rigor as the assessment of primary outcomes.
CONCLUSIONS
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2.
3.
3.
4.
4.
High-precision sensors are necessary to record maximum insertion torque values. Digital sensors are recommended over mechanical devices because they can record consecutive insertion torque levels at highfrequency intervals and therefore provide an immediate curve of these values. This information can inform the clinician instantly about the risk of implant fracture, the quality of the bone, root contact, excessive tightening, and possibly stripping of the bone.9 Because success is a subjective qualitative value of stability, it should not be tested for associations with independent variables. Only objective quantitative recordings of stability should be assessed for possible associations with maximum insertion torque. Exchange of such objective readings between clinicians and research groups can speed up our understanding of variables that inuence the stability of orthodontic mini-implants in an exponential way. Registrations of primary and secondary failure rates are
5.
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7.
Currently, there is no evidence to recommend specic maximum insertion torque levels to obtain higher success rates of orthodontic mini-implants. We found that an association between specic maximum insertion torque values and success of orthodontic mini-implants was analyzed only in nonrandomized studies of low quality. Success is a subjective qualitative recording of stability and should not be considered as a reliable measure for testing associations with maximum insertion torque. On the other hand, recordings with objective measuring devices should be applied for such assessments and should become the gold standard for testing associations between the stability of orthodontic mini-implants and independent variables. Subsequent studies should record maximum insertion torque values with digital torque sensors and not with mechanical devices. Numerous associations were proposed between maximum insertion torque levels and implant-, patient-, location-, and surgery-related factors, but all were rejected by our selection criteria. The many opposing associations conrmed the heterogeneity within and between studies and the lack of control of confounding factors. We presented the risk of multiple publication bias and showed the need of retrieving individual patient data from each eligible study. This systematic review could be considered a negative study, because no evidence-based conclusions could be drawn. Although studies with signicant results are more likely to be published, the contribution of negative (a misnomer) articles is as important as the former studies, because they have an important role for placing the validity of the current literature in perspective.46,76-79 They can further control citation and publication bias, show the need for future studies, and help in designing such research. Future research on our PICO question should pay special attention to controlling the various forms of bias that were identied because the probability
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that a research claim is true strongly depends on systematic error. Recordings of adverse effects during mini-implant insertion were generally sparse. Precise denitions of adverse effects and their character and intensity should become part of every future research protocol.73
We wish to extend special thanks to Dr. Louis Keith at Northwestern University, Mary Kreinbring at the ADA library, and Rossella Bassi.
SUPPLEMENTARY DATA
Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/ 10.1016/j.ajodo.2012.06.013.
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titanium screw mini-implants in the cortical bone of dog femurs. Int J Oral Maxillofac Surg 2008;37:647-50. 72. Chen Y, Lee JW, Cho WH, Kyung HM. Potential of self-drilling orthodontic microimplants under immediate loading. Am J Orthod Dentofacial Orthop 2010;137:496-502. 73. Kravitz ND, Kusnoto B. Risks and complications of orthodontic miniscrews. Am J Orthod Dentofacial Orthop 2007;131(Suppl):S43-51. 74. American Society for Testing and Materials standard F1839-081. Standard specication for rigid polyurethane foam for use as a standard material for testing orthopaedic devices and instruments (editorially corrected, August 2009). West Conshohocken, Pa: ASTM International; 2008. Available at: www.astm.org. Accessed October 15, 2010.
75. Roberts WE, Roberts JA. Endosseous miniscrews: historical, vascular, and integration perspectives. In: Nanda R, Uribe FA, editors. Temporary anchorage devices in orthodontics. St Louis: Mosby Elsevier; 2009. 76. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet 1991;337:867-72. 77. Song F, Eastwood AJ, Gilbody S, Duley L, Sutton AJ. Publication and related biases. Health Technol Assess 2000;4:1-115. 78. Ledford H. Weighing up the evidence. Nature 2007;447:512-3. 79. Koletsi D, Karagianni A, Pandis N, Makou M, Polychronopoulou A, Eliades T. Are studies reporting signicant results more likely to be published? Am J Orthod Dentofacial Orthop 2009;136:632.e1-5.
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Appendix Table I. Abstracts retrieved by electronic searching, hand searching, and reference searching* with subject
headings and keywords: orthodontics, torque, implant, mini implant, micro implant, microimplant, screw, mini screw, miniscrew, micro screw, microscrew, and temporary anchorage devicey
Source of records Google Scholar Beta PubMed (Medline) Embase (Ovid) CENTRAL Science Direct Scopus Web of Science LILACS AJOL Grey literature Hand searching References, review articles References, selected articles Total Date of search 24-02-2012 24-02-2012 Week 7 2012 24-02-2012 24-02-2012 24-02-2012 24-02-2012 24-02-2012 24-02-2012 24-02-2012 24-02-2012 24-02-2012 24-02-2012 Abstracts per search engine (n) 7922 111 824 26 239 154 162 26 0 0 additional abstracts to all found under Google Scholar 5 3 8 9480 with overlapping articles
*All search strategies were copied and pasted from the original without retyping, since this could have introduced errors.44 yFor each search engine, the appropriate characters were used to truncate or explore search terms.
Appendix Table II. Articles excluded by the selection criteria (n 5 30)

Authors Ohmae et al1 Bchter et al2 u Huja et al3 Yano et al4 Morais et al5 Wu et al6 Serra et al7 Iijima et al8 Kim et al9 Chen et al10 Tsaousidis and Bauss11 Kim et al12 Su et al13 Chang et al14 Zhao et al15 Wu et al16 Dao et al17 Hembree et al18 Chen et al19 Kang et al20 Mortensen et al21 Viwattanatipa et al22 Santiago et al23 Mo et al24 Kim et al25 Zhang et al26 Asscherickx et al27 Hong et al28 Hong et al29 Park et al30 Year of publication 2001 2005 2005 2006 2007 2007 2008 2008 2008 2008 2008 2008 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2010 2010 2010 2010 2011 2011 2011 Reason for exclusion B B B B B B B C B A A A C B B B B B B B B A A B A B D C C E
Exclusion criteria: A, human study that did not assess insertion torque values; B, animal study; C, laboratory study; D, human study with implant diameter .2.5 mm; E, human study on dental implants.
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Appendix Table III. Implant-related factors in maximum insertion torque studies

Authors Motoyoshi et al2 Motoyoshi et al21 Motoyoshi et al22 Arismendi et al27 Chaddad et al24 Implant type and number 124 Biodent Diameter (D) Additional Length (L) characteristics Material Finishing Sterilization D 1.6 mm ND Titanium ND ND L 8 mm 169 Biodent Tapered D 1.6 mm ND Titanium ND ND L 8 mm 87 Biodent Tapered D 1.6 mm ND Titanium ND ND L 8 mm 34 Leone Cylindrical D 1.5 and 2.0 mm ND Stainless steel ND ND L 10.0 and 12 mm 17 Dual top Dual Top: machined Dual Top: ND Titanium ND ND and tapered D 1.4, 1.6, 2.0 mm L 6.0, 8.0, 10.0 mm 15 C implant C implant: surface C implant: ND Titanium ND ND treated and tapered D 1.8 mm L 8.5 mm 134 Biodent Tapered D 1.6 mm ND Titanium ND ND L 8 mm 120 Sistema Cylindrical PDS D 1.5 mm ND Titanium ND ND Nacional de L 6 and 8 mm Implantes 160 ACR Tapered SDS D 1.5 mm ND Titanium ND ND L 6 and 8 mm Design Tapered
Chaddad et al24
Motoyoshi et al23 Suzuki and Suzuki28
Suzuki and Suzuki28
SDS, Self-drilling screws; PDS, predrilling screws; ND, not described.
Appendix Table IV. Patient-related factors in maximum insertion torque studies

Authors Motoyoshi et al2 Motoyoshi et al21 Number of patients, sex, and number of implants 4 males (10 implants) 37 females (114 implants) Adolescents: 83 implants 6 males and 24 females Adults: 86 implants 3 males and 24 females 4 males (11 implants) 28 females (76 implants) 9 patients (34 implants) Sex ND 10 patients (32 implants) Sex ND 10 males (25 implants) 42 females (109 implants) 40 males and 55 females 290 implants Age (y) Average: 24.9 6 6.5 Range: 13.3-42.8 Adolescents: mean, 15.9 6 1.9; range: 11.7-18.9 Adults: mean, 26.2 6 5.6; range: 20.4-36.1 Average: 24.4 6 6.5 Range: 14.6-42.8 ND Range: 13-65 Average: 26.1 6 8.4 Range: 13.9-63.5 Average: 25.6 6 6.7 Range: 12-46.6 Physical status ND ND Dental status ND ND
ND No systemic disease Healthy ND ND
ND No periodontal problems ND ND ND
ND, Not described.
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Appendix Table V. Location-related factors in maximum insertion torque studies

Authors Motoyoshi et al2 Motoyoshi et al21 Motoyoshi et al22 Arismendi et al27 Chaddad et al24 Motoyoshi et al23 Suzuki and Suzuki28 ND, Not described. Implant site Posterior buccal alveolar bone in maxilla and mandible Posterior buccal alveolar bone in maxilla and mandible Posterior buccal alveolar bone in maxilla and mandible Buccal alveolar bone in maxilla and palatal bone Posterior buccal alveolar bone in maxilla and mandible Posterior buccal alveolar bone in maxilla and mandible Alveolar bone in maxilla and mandible and in midpalatal suture area Keratinized/nonkeratinized mucosa ND Keratinized gingiva ND Both Both ND Keratinized gingiva Exposed or closed ND ND ND ND ND ND Exposed
Appendix Table VI. Surgery-related factors in maximum insertion torque studies

Authors Motoyoshi et al2 Motoyoshi et al21 Motoyoshi et al22 Arismendi et al27 Chaddad et al24 Motoyoshi et al23 Suzuki and Suzuki28 Torquing device Mechanical Mechanical Mechanical ND Mechanical Mechanical Digital Flap or apless surgery Flapless Flapless Flapless Flapless Flapless Flapless Flapless Distance between screws NA NA NA NA NA NA NA Direction of insertion ND 30 to the long axis of the tooth ND 30 -60 ND ND ND Insertion speed ND ND ND ND ND ND ND Assessment of insertion torque At nal turn ND ND ND ND At nal turn At nal turn
ND, Not described; NA, not applicable.
Appendix Table VII. Surgery-related factors in maximum insertion torque studies

Authors Motoyoshi et al2 Motoyoshi et al21 Motoyoshi et al22 Arismendi et al27 Chaddad et al24 Motoyoshi et al23 Suzuki and Suzuki28 Insertion technique PDI PDI PDI PDI SDI PDI PDI and SDI Starter pilot hole ND ND ND ND Yes ND SDI: No PDI: Yes Full-length pilot hole D 1.3 mm Full length D 1, 1.3, 1.4 mm Full length D 1.3 mm Full length D 1.1, 1.3, 1.5, 1.7 mm Full length NA D 1.0, 1.3, 1.4 mm Length ND PDI: full length Insertion depth Full length Full length Full length Full length ND ND ND Axial load ND ND ND ND ND ND ND Stripping or stalling NM NM NM NM NM NM NM
D, Diameter; SDI, self-drilling insertion technique; PDI, predrilling insertion technique; ND, not described; NA, not applicable; NM, not measured.
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Appendix Table VIII. Orthodontics-related factors in maximum insertion torque studies

Authors Motoyoshi et al2 Motoyoshi et al21 Type of orthodontic Timing of force movement application Retraction of anterior Immediate (at surgery) teeth in both jaws Retraction of anterior Early load, adolescents: teeth in both jaws Average: 2.6 weeks Late load, adolescents: Average: 13.2 weeks Early load, adults: Average: 2.2 weeks Retraction of anterior Immediate (at surgery) teeth in both jaws Intrusion of maxillary 8 days after surgery molars Various movements Immediate (at surgery) in both jaws ND Immediate (at surgery) Retraction of anterior After minimum healing teeth in both jaws period of 2 weeks Force magnitude \200 g Duration of force Type of force application ND 6 months or more 6 months or more Direction of force ND ND
Approximately 200 g Continuous
ND 42.4-84.9 g 50-250 g \200 g 50 g
ND Intermittent Both ND Continuous
6 months or more
ND
6.5 months Diagonal to Range: 3-9 months vertical 150 days ND 23.1 6 6.7 months ND 44 6 11 weeks ND
ND, Not described.
Appendix Table IX. Implant maintenance-related factors in maximum insertion torque studies
Authors Motoyoshi et al2 Motoyoshi et al21 Motoyoshi et al22 Arismendi et al27 Chaddad et al24 Motoyoshi et al23 Suzuki and Suzuki28 Antibiotic protocol 3 days PI 3 days PI 3 days PI ND ND 3 days PI ND Chlorhexidine protocol ND ND ND ND 1 week PI ND ND Oral hygiene protocol ND ND ND ND ND ND ND Peri-implantitis protocol ND ND ND ND ND ND ND Mobility protocol ND ND ND First week and then every month ND ND ND
PI, Postimplant placement; ND, not described.
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REFERENCES OF EXCLUDED ARTICLES 1. Ohmae M, Saito S, Morohashi T, Seki K, Qu H, Kanomi R, et al. A clinical and histological evaluation of titanium mini-implants as anchors for orthodontic intrusion in the beagle dog. Am J Orthod Dentofacial Orthop 2001;119:489-97. 2. Bchter A, Wiechmann D, Koerdt S, Wiesmann HP, Piffko J, u Meyer U. Load-related implant reaction of mini-implants used for orthodontic anchorage. Clin Oral Implants Res 2005;16:473-9. 3. Huja SS, Litsky AS, Beck FM, Johnson KA, Larsen PE. Pull-out strength of monocortical screws placed in the maxillae and mandibles of dogs. Am J Orthod Dentofacial Orthop 2005;127:307-13. 4. Yano S, Motoyoshi M, Uemura M, Ono A, Shimizu N. Tapered orthodontic miniscrews induce bone-screw cohesion following immediate loading. Eur J Orthod 2006;28:541-6. 5. Morais LS, Serra GG, Muller CA, Andrade LR, Palermo EF, Elias CN, et al. Titanium alloy mini-implants for orthodontic anchorage: immediate loading and metal ion release. Acta Biomater 2007;3: 331-9. 6. Wu JC, Huang JN, Zhao SF. Bicortical microimplant with 2 anchorage heads for mesial movement of posterior tooth in the beagle dog. Am J Orthod Dentofacial Orthop 2007;132:353-9. 7. Serra G, Morais LS, Elias CN, Meyers MA, Andrade L, Muller C, et al. Sequential bone healing of immediately loaded mini-implants. Am J Orthod Dentofacial Orthop 2008;134:44-52. 8. Iijima M, Muguruma T, Brantley WA, Okayama M, Yuasa T, Mizoguchi I. Torsional properties and microstructures of miniscrew implants. Am J Orthod Dentofacial Orthop 2008;134: 333.e1-6. 9. Kim JW, Baek SH, Kim TW, Chang YI. Comparison of stability between cylindrical and conical type mini-implants. Angle Orthod 2008;78:692-8. 10. Chen YJ, Chang HH, Lin HY, Lai EH, Hung HC, Yao CC. Stability of miniplates and miniscrews used for orthodontic anchorage: experience with 492 temporary anchorage devices. Clin Oral Implants Res 2008;19:1188-96. 11. Tsaousidis G, Bauss O. Inuence of insertion site on the failure rates of orthodontic miniscrews. J Orofac Orthop 2008;69:349-56. 12. Kim SH, Cho JH, Chung KR, Kook YA, Nelson G. Removal torque values of surface-treated mini-implants after loading. Am J Orthod Dentofacial Orthop 2008;134:36-43. 13. Su YY, Wilmes B, Hnscheid R, Drescher D. Comparison of selfo tapping and self-drilling orthodontic mini-implants: an animal study of insertion torque and displacement under lateral loading. Int J Oral Maxillofac Implants 2009;24:404-11. 14. Chang CS, Lee TM, Chang CH, Liu JK. The effect of microrough surface treatment on miniscrews used as orthodontic anchors. Clin Oral Implants Res 2009;20:1178-84. 15. Zhao L, Xu Z, Yang Z, Wei X, Tang T, Zhao Z. Orthodontic miniimplant stability in different healing times before loading: a microscopic computerized tomographic and biomechanical analysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009;108:196-202.
16. Wu J, Bai YX, Wang BK. Biomechanical and histomorphometric characterization of osseointegration during mini-screw healing in rabbit tibiae. Angle Orthod 2009;79:558-63. 17. Dao V, Renjen R, Prasad HS, Rohrer MD, Maganzini AL, Kraut RA. Cementum, pulp, periodontal ligament, and bone response after direct injury with orthodontic anchorage screws: a histomorphologic study in an animal model. J Oral Maxillofac Surg 2009;67: 2440-5. 18. Hembree M, Buschang PH, Carrillo R, Spears R, Rossouw PE. Effects of intentional damage of the roots and surrounding structures with miniscrew implants. Am J Orthod Dentofacial Orthop 2009;135:280.e1-9. 19. Chen Y, Kang ST, Bae SM, Kyung HM. Clinical and histologic analysis of the stability of microimplants with immediate orthodontic loading in dogs. Am J Orthod Dentofacial Orthop 2009;136:260-7. 20. Kang YG, Kim JY, Lee YJ, Chung KR, Park YG. Stability of miniscrews invading the dental roots and their impact on the paradental tissues in beagles. Angle Orthod 2009;79:248-55. 21. Mortensen MG, Buschang PH, Oliver DR, Kyung HM, Behrents RG. Stability of immediately loaded 3- and 6-mm miniscrew implants in beagle dogsa pilot study. Am J Orthod Dentofacial Orthop 2009;136:251-9. 22. Viwattanatipa N, Thanakitcharu S, Uttraravichien A, Pitiphat W. Survival analyses of surgical miniscrews as orthodontic anchorage. Am J Orthod Dentofacial Orthop 2009;136:29-36. 23. Santiago RC, de Paula FO, Fraga MR, Picorelli Assis NM, Vitral RW. Correlation between miniscrew stability and bone mineral density in orthodontic patients. Am J Orthod Dentofacial Orthop 2009; 136:243-50. 24. Mo SS, Kim SH, Kook YA, Jeong DM, Chung KR, Nelson G. Resistance to immediate orthodontic loading of surface-treated miniimplants. Angle Orthod 2010;80:123-9. 25. Kim YH, Yang SM, Kim S, Lee JY, Kim KE, Gianelly AA, et al. Midpalatal miniscrews for orthodontic anchorage: factors affecting clinical success. Am J Orthod Dentofacial Orthop 2010;137:66-72. 26. Zhang L, Zhao Z, Li Y, Wu J, Zheng L, Tang T. Osseointegration of orthodontic micro-screws after immediate and early loading. Angle Orthod 2010;80:354-60. 27. Asscherickx K, Vannet BV, Bottenberg P, Wehrbein H, Sabzevar MM. Clinical observations and success rates of palatal implants. Am J Orthod Dentofacial Orthop 2010;137:114-22. 28. Hong C, Lee H, Webster R, Kwak J, Wu BM, Moon W. Stability comparison between commercially available mini-implants and a novel design: part 1. Angle Orthod 2011;81:692-9. 29. Hong C, Truong P, Song HN, Wu BM, Moon W. Mechanical stability assessment of novel orthodontic mini-implant designs: part 2. Angle Orthod 2011;81:1001-9. 30. Park KJ, Kwon JY, Kim SK, Heo SJ, Koak JY, Lee JH, et al. The relationship between implant stability quotient values and implant insertion variables: a clinical study. J Oral Rehabil 2012; 39:151-9.

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SYSTEMATIC REVIEW

Insertion torque and success of orthodontic mini-implants: A systematic review

MATERIAL AND METHODS

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Establish selection criteria

CRITERIA FOR CONSIDERING STUDIES

Establish search methods for identification of studies

Present flow diagram searching for studies

SEARCHING FOR STUDIES

Establish what data to extract

Conduct subgroup analyses when indicated

Present estimate of effect for each outcome

Define types of bias specific for eligible studies

Define rating parameters for magnitude, reliability and direction of bias

Assess risk of bias across outcomes (only in case of multiple outcomes)

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ASSESSMENT OF RISK OF BIAS FOR OUTCOMES

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Initial quality assessment (GRADE)

Final quality assessment (GRADE)

SUMMARY OF FINDINGS TABLE FOR EACH ELIGIBLE STUDY

Fig 1. Flow diagram for a protocol of a systematic review.29-33

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Search methods for identication of studies

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Additional records identified through other sources (n =16)

Records screened ( n =9480)

Records excluded (n =9443)

Full-text articles assessed for eligibility ( n= 37)

Full-text articles excluded, with reasons (n= 30)

Studies included in qualitative synthesis ( n=7 )

Fig 2. PRISMA ow diagram.32,33

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Performance bias, orthodontics

Performance bias, implant maintenance

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Assess criteria a,b,c and d

Conduct sensitivity analyses to assess the effects of procedural decisions on findings

Define general parameters that can affect GRADE ratings

Initial quality assessment (GRADE)

Final quality assessment (GRADE) of the metaanalysis

ASSESSING THE VALIDITY OF A BODY OF EVIDENCE SUMMARIZED IN A META-ANALYSIS

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Table II. Characteristics of maximum insertion torque studies

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Motoyoshi et al23 2010

Suzuki and Suzuki28 2011

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