1

The replacement or repair of posterior amalgam restorations: when is it indicated in the permanent dentition?
An Evidence-Based Literature Review
Submitted to: Dr. Carlos Quionez and Dr. James Leake Department of Community Dentistry, Faculty of Dentistry, University of Toronto Submitted by: Ji Hoon Hyun Hon. B.Sc. Danielle Musselman Hon. B.Sc. Kaveh Nedamat Hon. B.Sc. Natascha Rodrigues Michelle Wong Robert Wong In fulfillment of DEN207Y Community Dentistry academic requirements. Contact: Michelle Wong Faculty of Dentistry, University of Toronto 124 Edward Street, Toronto, Ontario, Canada M5G 1G6 (416) 979- 4750 ext. 3559 michellewong.wong@utoronto.ca March 20, 2008 Word Count: 2778

Table of Contents
Abstract ........................................................................................................................................... 3 Introduction..................................................................................................................................... 4 Methods........................................................................................................................................... 6
Search Strategy ......................................................................................................................................... 6 Inclusion Criteria ...................................................................................................................................... 7 Exclusion Criteria ..................................................................................................................................... 7 Validity Instrument ................................................................................................................................... 7 Literature Search Results .......................................................................................................................... 8

Results........................................................................................................................................... 10 Discussion ..................................................................................................................................... 14 Conclusion .................................................................................................................................... 18 Appendix A:.................................................................................................................................. 19 Checklist to Assess Evidence of Efficacy of Therapy or Prevention ........................................... 19 Appendix B: Evidence Tables ..................................................................................................... 20 Appendix C: Paterson FM et al. Criteria ..................................................................................... 22 Appendix D: Hickel R et al.s Criteria to evaluate restorations .................................................. 24 Acknowledgements....................................................................................................................... 27 References..................................................................................................................................... 28

Abstract
Dental practitioners are constantly faced with the decision to replace or repair a failed posterior amalgam restoration yet no set guidelines exist. The purpose of this paper is to conduct an evidence-based literature review of when to replace or repair failed posterior amalgam restorations in the permanent dentition. Eleven scientific electronic databases including Pubmed and Ovid were searched using MeSH and relevant keywords. The search yielded a total of 4015 articles. Of these, 310 were found to be relevant after screening at the title stage and this number was further reduced to 53 based on the inclusion/exclusion criteria. Three articles were selected for critical appraisal and validity scoring; ultimately, two articles were accepted to be of reasonable quality and study design. The studies indicate that repair is an acceptable and conservative method of treating failed amalgam restorations; however, no comparative data on longevity of repair versus replacement of amalgam is available. Unfortunately, there is an insufficient body of evidence-based literature to make a recommendation as to when a posterior amalgam should be replaced or repaired. Future work must be conducted.

Introduction
Dental amalgam is generally regarded as an ideal restorative material due to its high strength, longevity and cost-effectiveness (1). Yet, a common phrase within the dental community is if you build it, it will fail. This is true for dental amalgam restorations, with one study claiming that replacing restorations occupies 72% of a dental practitioners time (2). In this regard, there is debate amongst dental professionals as to when an amalgam should be repaired or replaced. Does a cracked isthmus call for complete removal or simply repair? What about a deficient margin or a restoration that has suffered recurrent decay? These situations are routinely encountered in dental practices, but are the clinical treatments based on the literature or existing dogmas? According to the literature, the most frequently reported reason for failure of an amalgam restoration is recurrent or secondary caries (3, 4). The second most frequently reported factor is fracture, which included isthmus/bulk fracture, marginal fracture and tooth fracture (3-9). Bulk fractures were predominant in restorations that had three or four surfaces, whereas marginal gaps or marginal leakage were more frequent in restorations with one or two surfaces (3). Other factors include esthetic concerns, marginal defects, poor anatomy, excessive wear, marginal discolouration, pain, sensitivity, and colour changes (5, 10). According to this literature, amalgam repair should be used more often since it is more conservative, as it removes less tooth structure, and especially with newer amalgam bonding adhesives that provide a stronger bond between the old and new amalgam (11, 12). Nonetheless, the literature is conflicted in terms of the success of many of these approaches (11). In this study, replacement of amalgam was defined as the complete removal of the existing amalgam restoration and its replacement with another dentin substitute or prosthesis.

5 Amalgam repair was defined as the replacement of the defective or fractured aspect of the dental amalgam restoration with new amalgam. In turn, this paper is an evidence-based literature review of the replacement or repair of failed posterior amalgam restorations in the permanent dentition.

Methods
Search Strategy
An initial search for relevant academic papers was performed using eleven electronic databases, which can be seen in Table 1. The MeSH terms used were: a) Dental Amalgam OR Dental Restoration Failure AND posterior AND replace* repair* NOT implant NOT denture b) Dental Amalgam OR Dental Restoration Failure AND posterior AND repair* NOT implant NOT denture Additionally when MeSH was not applicable, four keyword search phrases were used: a) Amalgam AND Posterior AND Restor* AND Replace* b) Amalgam AND Posterior AND Restor* AND Repair c) Amalgam AND Posterior AND Restor* AND Remov* d) Amalgam AND Posterior AND Restor* AND Fail*

To finalize the literature search, titles of articles were screened based on relevance to the research question: when is the replacement or repair of posterior amalgam restorations indicated in the permanent dentition? Abstracts were acquired for the accepted titles. They were screened based on the inclusion/exclusion criteria presented below. Duplicates were removed at this stage. Subsequently, full articles were also collected and screened based on the inclusion/exclusion criteria. To further achieve a comprehensive search, reference lists of accepted articles were scanned. Dr. A. Jokstad, Faculty of Dentistry, University of Toronto was also consulted for additional resources and references.

Inclusion Criteria
Articles selected for this report met the following criteria: 1. English 2. Available through Local Holdings (University of Toronto Library Resources) 3. Publication date of January 1964 to present 4. Human subjects with permanent dentition

Exclusion Criteria
Articles selected for this report excluded the following criteria: 1. Personal or expert opinion 2. In vitro trials 3. Topic focused solely on the longevity of the amalgam restoration and not of replacement or repair 4. Languages other than English

Validity Instrument
Abstracts and full text titles were assessed by two independent reviewers using the inclusion/exclusion criteria. Any discrepancies between the two reviewers were discussed between all group members. The validity and quality of the resultant three articles was assessed using Checklist to Assess Evidence of Efficacy of Therapy or Prevention developed by J.L. Leake (Appendix A). Each article was scored by two independent reviewers and could receive a maximum score of fifteen. When a discrepancy in the article score of two or more points was demonstrated, a final score was determined after discussion between all six group members. All studies receiving a score of 9 or more were retained.

Literature Search Results

The literature search resulted in a total yield of 4015 articles. The total number of relevant articles yielded after the title stage was 310 (Table 2 provides details). The 310 abstracts were further reduced to 53 based on the inclusion/exclusion criteria. Three articles were ultimately selected for validity scoring. Upon reviewing reference lists located at the back of the accepted articles, no additional articles were accepted. The consultation with Dr. Jokstad yielded no additional resources and references. Table 1: Electronic Literature Search of Internet and Academic Sources Literature Search Total # # Abstracts Hits retrieved Academic Literature Database Search (accessed through U of T Library Resources) Pubmed 189 30 Ovid: MEDLINE, CINAHL (Cumulative Index to Nursing & Allied Health Literature), EMBASE, All Evidence Based Medicine Reviews (Cochrane Database of Systematic Reviews (CDSR), American College of Physicians (ACP) Journal Club, Database 208 82 of Abstracts of Reviews of Effects (DARE), and CCTR (formerly Cochrane Controlled Trials Register), Cochrane Methodology Register (CMR), Health Technology Assessment (HTA), and NHS Economic Evaluation Database (NHSEED). Scopus 1483 74 Web of Science 110 44 BIOSIS 24 16 Grey Literature Internet Search American Assoc. Operative http://www.jopdent.org/ 1 0 Dentistry Guidelines National Institutes for Health and Clinical Evidence (NICE) http://www.nice.org.uk/ 0 0 Method Sources Google Scholar National Institute of Dental and Craniofacial Research (NIDCR) Journal of the Canadian Dental Association (JCDA) Journal of American Dental Association (JADA) http://scholar.google.ca/ http://www.nidcr.nih.gov/ http://www.cda-adc.ca/jcda/ http://jada.ada.org/ 843 44 311 802 27 3 7 27

Table 2: Number of Abstracts selected after rejection at title stage

Ovi d Am er. A Den ssoc. O tist ry G perat iv uid elin e es NI C E We bo f Sc i en ce ola r Goo gle Sch

Pu b me d

Search Terms: MeSH: Dental Amalgam or Dental Restoration Failure AND posterior AND (replace* OR repair*) NOT implant NOT denture Amalgam AND Posterior AND Restor* AND Replace* Amalgam AND Posterior AND Restor* AND Repair Amalgam AND Posterior AND Restor* AND Remov* Amalgam AND Posterior AND Restor* AND Fail*

17

N/A

N/A

N/A

N/A

N/A

23

N/A

10 1 0 12

22 4 6 33

1 0 0 0

0 0 0 0

17 4 6 17

5 1 2 8

8 4 8 7

0 0 0 0

7 0 0 0

4 0 0 0

28 5 8 33

Table 3: Summary of Literature Search Results

Yield 4015 After Rejecting at Title Stage 310 After Rejecting At Abstract Stage 53 After Rejecting At Full Text Stage 3 Accepted 2

Sco pus

NI D CR

Bio sis

A JCD

AD A

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Results
Two studies were identified that investigated the effectiveness of alternative treatments for replacing defective amalgam restorations, one randomized controlled trial (13) and one prospective cohort clinical trial (14). Both studies were abstracted into evidence tables (Appendix 1). Moncada et al. (13) studied patients treated at the Operative Dentistry Clinic at the College of Dentistry, Univeridad de Chile. Sixty-six patients with 271 defective amalgam and composite resin restorations were randomly assigned to five groups: sealant (etch and resinbased sealant), refurbish (smooth and polish), repair (removal of restorative material adjacent to defect and repair with amalgam or resin-based filling), replacement (complete removal of defective restoration and complete replacement) and no treatment. Sixty-four of the sixty-six (97%) patients returned after a 12-month period and were assessed by two independent examiners; examiners performed calibration exercises at baseline (Kappa 0.74) and upon recall evaluation (Kappa 0.81). The authors found all treatment groups showed improvements from baseline, based on ten clinical characteristics using Ryge USPHS criteria (Table 4). A change from bravo to alfa was considered an improvement, while a change from alfa to bravo or charlie indicated deterioration. Most improvements from bravo to alfa were from the sealant group, representing a 16-fold improvement (p<0.0001). A four-fold (p<0.0001), three-fold (p=0.003) and two-fold (p<0.0001) increase in alfa rating was observed in the replaced, repaired and refurbished groups, respectively. The no treatment group was the only one to show a reduced rating from alfa to either bravo or charlie (p=0.242). The authors concluded that repairing defective restorations, instead of complete replacement, is an acceptable, economical and efficient technique causing minimal loss of tooth structure and increasing the longevity of the

11 restoration; longevity, however, was not actually measured as the authors only collected data at the 1-year recall examinations. Moreover, the authors failed to report the results for the resinbased and amalgam restorations separately; this study was still included in the report due to the lack of data on this subject (13). Table 4: Modified Ryge USPHS clinical criteria.
Clinical Characteristics Color Alfa The restoration matches in color and translucency to adjacent tooth structure Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface The general contour of the restoration follows the contour of the tooth The surface of the restoration has no surface defects There is no discoloration between the restoration and tooth There is no stain on the restoration, or the stain is equal on both the tooth and restoration Normal No sensitivity when an air syringe is activated for 2 seconds at a distance of 0.5 in. from the restoration with the facial surface of the proximal tooth covered with gauze Bravo The mismatch in color and translucency is within the acceptable range of tooth color and translucency Explorer falls into crevice when drawn across the restoration/tooth interface The general contour of the restoration does not follow the contour of the tooth The surface of the restoration has minimal surface defects There is discoloration on less than half of the circumferential margin There is more stain on the restoration than on the surrounding tooth structure Charlie The mismatch is outside the acceptable range of color and translucency Dentin or base is exposed along the margin The restoration has an overhang

Marginal adaptation

Anatomic form Surface roughness

The surface of the restoration has severe surface defects Marginal staining There is discoloration on more than half the circumferential margin Interfacial staining The stain cannot be polished off the restoration (body discoloration) Contact Light None Postoperative Sensitivity is present when Sensitivity is present sensitivity an air syringe is activated when an air syringe is for 2 seconds at a distance activated for 2 seconds of 0.5 in. from the at a distance of 0.5 in. restoration with the facial from the restoration surface of the proximal with the facial surface tooth covered with gauze of the proximal tooth and ceases when the covered with gauze and stimulus is removed does cease when the stimulus is removed Secondary caries There is no clinical N/A There is clinical diagnosis of caries diagnosis of caries Luster of restoration The restoration surface is The restoration surface is The restoration surface shiny and has an enameldull and somewhat opaque is distinctly dull and like, translucent opaque and is esthetically displeasing Reproduced from: Moncada, GC, Martin, J, Fernandez, E, Vildosola, PG, Caamano, C, Caro, MJ, Mjor, IA, Gordon, VV. Alternative treatments for resin-based composite and amalgam restorations with marginal defects: A 12-month clinical trial. General Dentistry 2006;50(5):314-8.

12 The second study by Gordan et al. (14) was very similar in methodology and analysis; however the study type was a prospective cohort clinical trial. Gordan et al. recruited forty-five patients with 113 defective amalgam restorations from the Operative Dentistry Clinic, College of Dentistry, University of Florida and randomly assigned them to five groups: repair, sealing, refurbishing, total replacement and no treatment. The aim of this study was to assess the longevity of defective amalgam restorations treated by repair, sealant or refurbishing, rather than complete replacement. Contrary to their objective, the authors failed to report any significant period of longevity; outcomes after 1-year and 2-year recalls were reported. Loss to follow-up was 30% and 35% at the 1- and 2-year recall appointments, respectively. Te authors also fail to mention if the returning patients were the same at both recall exams. Two independent examiners evaluated the clinical quality of the restorations at baseline and after the assigned treatment, with inter-examiner agreement ratio of 92%. Similar to Moncada et al., this study used the Ryge USPHS clinical criteria and alfa, bravo and charlie assignments; however, Gordan et al. used only eight clinical characteristics for comparisons: 1) occlusal marginal adaptation, 2) proximal adaptation, 3) occlusal anatomic form, 4) proximal anatomic form, 5) occlusal contact, 6) proximal contact, 7) secondary caries and 8) post-operative sensitivity (Table 4). All restorations received a score for each clinical characteristic at baseline and post-treatment, except for those restorations receiving no treatment. Four outcomes were used to assess the change in clinical condition at 1- and 2-year recall exams: a grade of 1 signifying an upgrade from bravo to alfa, 0 as no change, -1 a downgrade from alfa the bravo or bravo to charlie, or 2 a downgrade from alfa to charlie. The authors reported a statistically significant improvement in all alternative groups when compared to the no treatment group for marginal adaptation and anatomical form characteristics. (14) The refurbishing and sealant groups showed statistically

13 significant downgrading on marginal adaptation and anatomic form compared to the replacement group and the repair group at both 1- and 2-year recalls. (14) Compared to the repair and replacement groups the no treatment group was significantly more likely to downgrade in marginal adaptation. The repair group showed no significantly different outcome when compared to the replacement group. (14) The authors concluded that repair or replacement of defective restorations with a bravo rating for marginal adaptation or anatomical form would result in the most predictable outcomes, and that repairing defective restorations offers the most conservative treatment (14).

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Discussion
The lack of clinical evidence is apparent in regard to the when to replace or repair posterior amalgam restorations; the majority of the literature pertaining to this topic consists of cross-sectional surveys ascertaining the reasons for replacement or repair of posterior amalgams. Only two relevant studies were retrieved from over 4000 articles found. In addition, the strength of the two studies is poor. The randomized control trial by Moncada et al., level of evidence I, failed to report if ethical approval was obtained and moreover, the study failed to differentiate between amalgam and composite restorations in their analysis and results. Additional limitations, which were also common to the prospective cohort study by Gordan et al., level of evidence II-B, include: insufficient duration of the studies; failure to report demographics of the study group and whether participants were treated equally; failure to report the method of randomization, the class of restoration being treated and the number of operators providing the treatment; and failure to control for external dental care. Furthermore, the results are arguably limited to the specific populations studied, thereby limiting external validity. Ultimately, there is insufficient evidence to make a recommendation regarding when a posterior amalgam should be replaced or repaired a clinical decision that is made by all dentists on a daily basis. This dilemma in the dentists practice prompted Paterson et al. in 1995 (10) to develop valid criteria for the replacement of amalgam restorations. The first stage of proposals was developed by a panel of dental academics using a modified Delphi technique which employed sequential questionnaires in order to aggregate judgments and reach a consensus opinion. The questionnaires were sent to individual academic dentists and general dental practitioners in Scotland who were asked to comment on the issues being discussed and to provide reasons for their choice.

15 The first round of the Delphi questionnaire consisted of nineteen advisory statements on criteria to be adopted when considering whether or not an amalgam restoration should be replaced. The panel was asked to comment on the format of the statements and to rate the proposals using the modified Turoff scoring system. Each statement was scored for five key items: importance, confidence, desirability, probability and feasibility. The panel reached a unanimous agreement that lost amalgam restorations should be replaced and amalgams that were fractured required replacement/repair. They also agreed that ditching at the margins was not an indication for the replacement or repair of the amalgam restoration. It was also concluded that amalgam restorations should be locally repaired rather than totally replaced. Consensus was also reached regarding the need to modify defective contact areas in Class II restorations. They also felt that replacement of amalgam due to allergy should only occur after specialist testing and advice. Finally, the panel concurred that before a decision to replace/repair could be made, an assessment of the patients caries risk and consideration of the individual restoration must occur. A consensus view, however, could not be reached regarding policy statements relating to pain management, white spots adjacent to restoration margins and dentinal staining of existing amalgam restorations. A reproduction of the criteria is included in Appendix C. The next stage in the development of the criteria is to send these statements to a panel of general dental practitioners to obtain their consensus view, again using the Delphi technique. To further the research on this topic, future studies addressing this clinical question will require improved design methods. According to Hickel et al.s 2007 review on conducting controlled clinical trials (15), an ideal restorative study is a randomized control trial with proper randomization and concealment of allocation. Split mouth design or a paired tooth design is

16 optimal although not always practical. Alternatively, a prospective cohort clinical trial is comparable study design but is considered second in the level of evidence ranking. Blinding in in vivo studies where there are two independent assessors is impossible due to the nature of restoration evaluation. The sample should be a good representation of the healthy population and the sample size should have adequate statistical power. Fully standardized procedures should be preset with regards to who will do the dental procedure, the technique and materials used, and who will assess the restoration. It is recommended that calibration training and interexaminer agreement be at the 85% level to ensure a reproducible restoration assessment. The analysis should account for the class of restoration because the dimension and size of the restoration may have an effect to the outcome. To adequately address whether clinicians should replace or repair posterior amalgams, only two intervention groups should be present as direct comparators: replacement or repair of amalgam restoration with amalgam. Including an untreated control group may be considered unethical where the standard of care is to provide some form of treatment. The restorations need to be validly and reliably measured. The Ryge Criteria is considered standard outcome measure for restorations; however, with the advent of new dental materials, more sensitive assessment or scoring methods need to be used. Hickel et al. refers to a two-step method of scoring where the first step evaluates clinical acceptability of the restoration based on the Ryge classification: Table 5: Overview of Ryge Criteria Ryge Classification Score Restoration is: Alpha 1 Excellent, fulfilling all quality criteria; tooth and/or surrounding tissues are adequately protected 2 Highly acceptable, though one or more criteria is not ideal; minor modifications can be made to the restoration but is not necessary Bravo 3 Sufficiently acceptable but with minor shortcomings in areas where any instrumentation may result in damage to the tooth; no adverse effects are anticipated

17 Charlie Delta 4 5 Unacceptable but repairable Unacceptable and must be replaced

A Modified Ryge USPHS Criteria (Table 4) has been developed and used in the studies found in our literature search. The second step is the classification of the restoration into aesthetic, functional and biological categories (Appendix D). For direct restorations, there is a recommendation for a three-year observation period involving four recall appointments: baseline at one-week (maximum one month) post-insertion, and yearly recalls at 12, 24, and 36 months. Still, follow-up times of longer duration such as for 7-10 years would be more appropriate. Studies have shown that repair and replace treatments have equivalent longevity after 5 years while repaired restorations show a lower survival rate compared to replaced restorations after 10 years (15). Until more research and guidelines are developed, the clinician must consider several factors prior to deciding when to replace or repair posterior amalgam restorations. The majority of factors that affect a clinicians decision is centered around the patient. The dentist must access and account for the patients caries risk, any present or future periodontal conditions, the size and location of the restoration, the medical history of the patient, in particular, manual dexterity, and their economic situation. The last factor could potentially be the most significant factor as whether to repair or replace the restoration. After assessment of the restoration, the determination of restoration prognosis and the presentation of treatment options to the patient, the dentist will ultimately perform the preferred treatment of the patient. In the case where the patient chooses the less expensive treatment of lower prognosis, the dentist will respect the patients decision. This clinical reality makes incorporation of evidence-based care difficult in instances where finances play a major role in the provision of treatment.

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Conclusion
The evidence-based literature on whether to replace or repair posterior amalgam restorations in the permanent dentition is scarce and of poor quality. Future studies should be carried out using the suggested improvements discussed in the paper, including statistically significant sample size and a high level design study such as a randomly controlled trial or prospective cohort. Due to the lack of good clinical evidence, we are unable to make an evidence-based recommendation as to when to replace or repair defective posterior amalgam restorations in the permanent dentition.

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Appendix A:
Checklist to Assess Evidence of Efficacy of Therapy or Prevention
Citation: 1. 2. 3. 4. 5. Was the study ethical? ___ Was a strong design used to assess efficacy? ___ Were outcomes (benefits and harms) validly and reliably measured? ___ Were interventions validly and reliably measured? ___ What were the results?

Was the treatment effect large enough to be clinically important? ___ Was the estimate of the treatment effect beyond chance and relatively precise? ___ If the findings were no difference was the power of the study 80% or better ___
6. Are the results of the study valid? Was the assignment of patients to treatments randomised? ___ Were all patients who entered the trial properly accounted for and attributed at its conclusion? i) Was loss to follow-up less than 20% and balanced between test and controls ___ ii) Were patients analysed in the groups to which they were randomised? ___ Was the study of sufficient duration? ___ Were patients, health workers, and study personnel blind to treatment? ___ Were the groups similar at the start of the trial? ___ Aside from the experimental intervention, were the groups treated equally? ___ Was care received outside the study identified and controlled for ___

7. Will the results help in caring for your patients?

Were all clinically important outcomes considered? ___ Are the likely benefits of treatment worth the potential harms and costs? ___

SCORE OUT OF 17 - ___N/A: Please note for our purposes, no difference and blinding statements did not apply. Thus, the score was taken over a denominator of 15. Adapted from: Fletcher, Fletcher and Wagner. Clinical epidemiology the essentials. 3rd ed. 1996, and Sackett et al. Evidence-based medicine: how to practice and teach

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Appendix B: Evidence Tables

Study Moncada GC et al. 2005. Alternative treatments for resinbased composite and amalgam restorations with marginal defects: a 12-month clinical trial Randomized controlled trial Population Inclusion: Age 18-80 (mean: unreported) Sex: unreported Dental school population (Operative Dentistry Clinic at College of Dentistry, Universidad de Chile) Exclusion: pt with: Contraindications for - Regular dental treatment due to medical history - Aesthetic demands that could not be resolved by alternative treatments - Xerostomia or taking medications that have been proven to reduce regular salivary flow significantly Intervention Size: n=271 defective restorations (66 participants) 5 groups: A: Sealant group (n= 48 restorations) B: Refurbishing group (smooth and polish) for AM or CR (n=73 restorations) C: Repair group for AM and CR (n=27 restorations) D: Replacement group with either AM or CR (n=42 restorations) Follow up: 12 months after treatment 97% returned for 12month recall (n=262 restorations, 64 participants) Control E: Untreated (n=81 restorations) Defective restorations left untreated Outcome measures Scored by two independent clinicians. Calibration exercises established agreement between the examiners (Cohens Kappa 0.74 at baseline); 12 month recall new calibration exercises performed following same criteria used at baseline (Kappa 0.81) Modified USPHS/Ryge Criteria: Assigned to one of three criteria groups: alfa, bravo, charlie, Based on 10 characteristics: colour match, marginal adaptation, anatomic form, surface roughness, marginal staining, interfacial staining, contact, postoperative sensitivity, secondary caries, luster of restoration Alfa is considered the greatest quality, followed by bravo, and charlie the lowest quality Considered improvement if there was a change from bravo to alfa; Considered deterioration if alfa to bravo (Details regarding Charlie to bravo not mentioned) At baseline: the defective restorations needed to score bravo to be included At baseline: defective restorations that scored charlie (unacceptable or failed) were excluded Test statistic: Results of all groups analyzed with a paired t-test to compare the pre- and postoperative conditions using SPSS 11.0.0 Gordon VV et al. 2006 2-year clinical evaluation of alternative treatments to Inclusion: Age 21-77 (mean: 56) Sex: unreported Dental School population (Operative Size: n=113 AM restorations (45 participants) 5 treatment groups: A: Repair group E: No-treatment (n=24 restorations) Restorations were examined visually and no treatment was done to the Scored by two independent clinicians. Calibration exercises (92% interexaminer agreement ratio) If there was disagreement, a third evaluator was called to examine the Change of clinical characteristic from baseline to 1 year and from baseline to 2 years: MARGINAL ADAPTATION: Sealant group presented a significant Checklist Score: 10/15 Limitations: No mention of restoration class Insufficient duration of Defective restorations that have a bravo rating for clinical characteristics other than marginal integrity and anatomical form do not need to be Outcome 95 restorations improved from bravo to alfa (representing 92% of improvement of total alfa changes) 8 restorations deteriorated from alfa to bravo (representing 8.0% of the alfa changes) greatest improvement from bravo to alfa involved marginal discrepancies treated with sealant (16 fold improvement in alfa rating (p<0.0001)) Replacement was second most effective, improvement in alfa rating was fourfold (p<0.0001) Repair treatment increased alfa rating threefold (p=0.003) Refurbished restorations had twofold increase in alfa rating (p<0.0001) Untreated group showed a reduced rating from alfa to bravo (p=0.242), signifying deterioration (Details about changes involving Charlie were not specified.) Critical appraisal Checklist Score: 10/15 Limitations: No mention of ethics board approval No mention of restoration class Results and statistics failed to report AM and CR separately Insufficient duration of study (12 mos) No description of the method of randomization; no mention of concealment of allocation No blinding: due to the nature of the intervention, it was impossible to use blinding. No mention of demographics of intervention groups, no mention if groups treated equally, no mention if care received outside study was controlled for External validity: limited to specific Chilean population Conclusion Repairing defective restorations is an acceptable technique that is conservative, simple, fast, and less expensive than complete replacements of restorations (Circumstances were not mentioned) Level of Evidence: I

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Study replacement of defective amalgam restorations Prospective cohort clinical trial Population Dentistry Clinic, College of Dentistry, University of Florida) Patient who had defective AM restorations that could be corrected with repair, sealant, or refurbishing the margins No contraindications for dental treatment Older than 18 yrs of age Ability to read English Exclusion: Pt with: Contraindications for: - Regular dental treatment due to medical history - Aesthetic demands that could not be resolved by alternative treatments - Xerostomia or taking medications that are proven to significantly reduce regular salivary flow - Patients with defective restorations that was deemed unacceptable or failed Intervention (n=20 restorations) B: Sealant group (n=23 restorations) C: Refurbishing group (smooth and polish) (n=23 restorations) D: Replacement group (n=23 restorations) Follow up: 1- and 2-year recall 1 year recall: 79 of 113 restorations were examined (70%) 2 year recall: 74 of the 113 restorations were examined (65%) It is unknown whether these are the same people or different people no details were mentioned. Control defective area Outcome measures restoration for final decision Modified USPHS/Ryge Criteria: Assigned to one of three criteria groups: alfa, bravo, charlie, Based on 8 clinical characteristics: occlusal marginal adaptation, proximal marginal adaptation, anatomic form: occlusal, anatomic form: proximal, occlusal contact, proximal contact, secondary caries and post-operative sensitivity Alfa is considered the greatest quality, followed by bravo, and charlie is considered the lowest quality At baseline: the defective restorations needed to score bravo to be included At baseline: defective restorations that scored charlie (unacceptable or failed) were excluded Considered improvement if there was a change from bravo to alfa; Considered deterioration if alfa to bravo All restorations received scores preoperatively (baseline) and posttreatment For each time interval (1-year and 2year recall) each restoration could have an outcome of: 1 (upgrade from bravo to alpha), 0 (no change), -1 (downgrade from alpha to bravo or from bravo to charlie) or -2 (downgrade from alpha to charlie). Statistical analysis: Kruskal-Wallis Test used to assess change in level at = 0.05 Outcome difference in marginal adaptation after 1yr only when compared to notreatment group The repair and replacement groups had statistically significant differences in marginal adaptation and anatomic form when compared to the notreatment group after 1- and 2-yrs Time 0-1 yrs: p-value Repair 0.003, Sealant 0.004, Refurbishment p>0.05, Replacement 0.003 Time 0-2 yrs: p-value Repair 0.035, Sealant p>0.05, Refurbishment p>0.05, Replacement 0.002 ANATOMIC FORM OCCLUSAL: Time 0-1 yrs: p-value Repair 0.008, Sealant p>0.05, Refurbishment p>0.05, Replacement 0.007 Time 0-2 yrs: p-value Repair 0.015, Sealant p>0.05, Refurbishment p>0.05, Replacement 0.00001 Intergroup Comparison of changes from baseline to 1- and 2-yr recalls Outcome of no-treatment, refurbishing and sealant groups were not significantly different at 1- and 2- yr recalls No-treatment, refurbishing, and sealant groups were significantly more likely to downgrade versus repair and replacement groups Repair group showed no significantly different outcome when compared to the replacement group. Critical appraisal study (2 years) No mention if participants at 1 year and 2 year recall were the same participants No description of the method of randomization; no mention of concealment of allocation No blinding: due to the nature of the intervention, it was impossible to do blinding. No mention of demographics of intervention groups, no mention if groups treated equally, no mention if care received outside study was controlled for Aim of study was stated to assess the longevity of amalgam restorations, however, this was not carried out into the results and discussion of the study External validity: limited to specific Florida population Conclusion replaced immediately Defective restorations with a bravo rating for marginal adaptation or anatomic form may need to be treated to avoid further deterioration Repair or replacement would offer the most predictable results Repair would be the most conservative treatment option

Level of Evidence: IIB

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Appendix C: Paterson FM et al. Criteria

Initial propositions on repair/replacement of amalgam agreed by academic group
Table reproduced from: Paterson, FM, Paterson, RC, Watts, A, and Blinkhorn, AS. Initial stages in the development of valid criteria for the replacement of amalgam restorations. Journal of Dentistry 1995;23(9): 137-143.

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Appendix D: Hickel R et al.s Criteria to evaluate restorations

Allocation of criteria to clinical observations Table reproduced from: Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clinical Oral Investigation 2007; 11: 5-33

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Acknowledgements
We would like to thank Dr. Carlos Quionez and Dr. James Leake of the Department of Community Dentistry, Dr. Asbjrn Jokstad of Department of Prosthodontics, and Dr. Dena Taylor of the Health Sciences Writing Centre, University of Toronto for their guidance and expertise.

This evidence-based report was conducted as an academic requirement of DEN207Y Community Dentistry.

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