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ORIGINAL ARTICLE

International Dental Journal 2012; 62: 3339 doi: 10.1111/j.1875-595X.2011.00084.x

Evaluation of mineral trioxide aggregate (MTA) versus calcium hydroxide cement (Dycal) in the formation of a dentine bridge: a randomised controlled trial
Fatou Leye Benoist1, Fatou Gaye Ndiaye1, Abdoul Wakhabe Kane1, Henri Michel Benoist2 and Pierre Farge3
1 Institute of Dentistry, Service of Conservative Dentistry and Endodontics; 2Service of Periodontics, Route de lUniversite , University Cheikh Anta Diop, Dakar, Senegal; 3Faculty of Odontology, Department of Conservative Dentistry and Endodontics, University Claude Bernard Lyon 1, Lyon Cedex, France.

Aim: To assess the effectiveness of mineral trioxide aggregate (MTA) used as an indirect pulp-capping material in human molar and premolar teeth. Methodology: We conducted a clinical evaluation of 60 teeth, which underwent an indirect pulpcapping procedure with either MTA or calcium hydroxide cement (Dycal). Calcium hydroxide was compared with MTA and the thickness of the newly formed dentine was measured at regular time intervals. The follow-up was at 3 and 6 months, and dentine formation was monitored by radiological measurements on digitised images using Mesurim Pro software. Results: At 3 months, the clinical success rates of MTA and calcium hydroxide were 93% and 73%, respectively (P = 0.02). At 6 months, the success rate was 89.6% with MTA, and remained steady at 73% with calcium hydroxide (P = 0.63). The mean initial residual dentine thickness was 0.23 mm, and increased by 0.121 mm with MTA and by 0.136 mm with calcium hydroxide at 3 months. At 6 months, there was an increase of 0.235 mm with MTA and of 0.221 mm with calcium hydroxide. Conclusions: A higher success rate was observed in the MTA group relative to the Dycal group after 3 months, which was statistically signicant. After 6 months, no statistically signicant difference was found in the dentine thickness between the two groups. Additional histological investigations are needed to support these ndings.
Key words: Calcium hydroxide, dentine bridge, mineral trioxide aggregate, pulp capping, randomised controlled trial

INTRODUCTION The consequences of pulp exposure from caries, trauma or unexpected tooth preparation procedures can be severe, with pain and infection. Pulp capping, in which a medicament is placed directly over the exposed pulp (direct pulp cap), or a cavity liner or sealer is placed over residual caries (indirect pulp cap), is an attempt to maintain pulp vitality and avoid more extensive treatments1. There are key procedures in the management of vital teeth with deep carious lesions24, which can be performed with high predictable long-term success rates5. Calcium hydroxide is the gold standard for pulp capping, following the initial publication by Zander6 in 1939. It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralisation7,8.
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From a clinical point of view, it enables successful maintenance of pulp vitality2, protects the pulp against thermoelectric stimuli and has an antimicrobial action. Calcium hydroxide is used as a reference for other capping agents, such as glass ionomer cement and adhesives912. However, in long-term clinical studies of pulp capping with calcium hydroxide-based materials, failure rates increase with the follow-up time3. Known disadvantages for this material include gradual degradation and tunnel defects in the newly formed dentine. In addition, an increased frequency of inammatory cells and localised areas of pulp necrosis have been reported over time1316. Mineral trioxide aggregate (MTA) is a pulp-sealing agent, essentially composed of a mixture of tricalcium silicate, dicalcium silicate, tricalcium aluminate, tetracalcium aluminoferrite and calcium sulphate dehydrate which are the main components of Portland cement
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Leye Benoist et al. with an addition of bismuth oxide in a 4 : 1 ratio for radio-opacity properties17,18. This bioactive silicate cement has been shown to be an effective pulp-capping material in canine models and in nonhuman primates19. The material appears to be successful because of its small particle size, sealing ability, alkaline pH when set and slow release of calcium ions. Investigators have reported that MTA induces pulp cell proliferation, cytokine release and subsequent hard tissue formation with the synthesis of a mineralised dentine interface similar to that of biological hydroxyapatite19. Most of the investigations conducted on MTA have involved the evaluation of the clinical and radiographic outcomes of pulp-capping procedures in either human primary20,21 or permanent20 teeth. Other human studies have reported histological observations of the pulpcapping procedure15,16,2224; their results conrm those reported in animal models13,25,26. Therefore, the capping ability of MTA is comparable with that of calcium hydroxide, but few clinical studies have evaluated both compounds simultaneously. For this reason, we conducted a prospective evaluation with both MTA and calcium hydroxide. The aim of this study was to assess the effectiveness of the pulp-capping materials by measuring the thickness of the newly formed dentine. MATERIALS AND METHODS The study design was a single-blind clinical trial realised in a sample of 60 paired permanent teeth (30 in each group) according to their type and site of caries. Selection criteria The teeth were selected from patients, aged 16 34 years, attending the faculty clinic of the Department of Dentistry, University Cheikh Anta Diop, Dakar, Senegal. The descriptive characteristics of the sample are given in Table 1. The mean age of the patients was 23.37 4.92 years for the calcium hydroxide group and 24.30 5.30 years for the MTA group. Thirty teeth were considered for each material (Table 1). The sample size was determined according to the literature review and in order to yield statistically signicant results for the measurement of the thickness of newly formed dentine in each group. No changes occurred in the outcomes after the trial had commenced. All the selected teeth presented an active deep carious lesion on either the occlusal or proximal surface. Reversible pulp inammation was present in all cases, as demonstrated by the transient painful response to pulp testing. Teeth with periodontal lesions, internal or external root resorptions, and patients with systemic medical conditions, were excluded from the study. Patients were informed about the procedure and provided written informed consent after the study had been approved by the ethics commission of our institution. All procedures were performed by one of the investigators in the study (FL) who is a qualied endodontist at our institution. Pulp vitality was tested by submitting the tooth to thermal and electrical testing: A cold stimulus was given by the use of ethyl chloride Electrical testing was carried out using an electric pulp tester (Electric Pulp Tester Averon PT 2.0, VEGA-PRO, Ekaterinburg, Russia). These tests were carried out at baseline, before pulp capping, and at the 3- and 6-month post-operative follow-up visits. Pulp-capping procedure MTA(ProRoot; Dentsply Tulsa Dental, Tulsa, OK, USA) and calcium hydroxide material (Dycal Ivory, Dentsply Caulk, Dentsply, L.D. Caulk, Milford, DE, USA) were used as pulp-capping agents. The operative procedure was performed as follows: After local peri-apical or intraligamentary anaesthesia of the tooth, rubber dam isolation was provided and carious lesions were removed using a three-step

Table 1 Distribution of teeth according to the age and gender of the subjects and the type of pulp-capping material
Capping material Gender n Mean MTA Ca(OH)2 Female Male Total Female Male Total 12 18 30 14 16 30 22.75 23.78 23.37 23.43 25.06 24.30 SD 5.74 4.43 4.92 3.857 6.34 5.30 Age (years) Min. 16 16 16 16 16 16 Max. 34 32 34 30 34 34 t-test* P value 0.58 0.39 t-test* P value 0.48

MTA, mineral trioxide aggregate; SD, standard deviation. *t-test between males and females in each pulp-capping material group. t-test between males and females in the two pulp-capping material groups.
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MTA versus calcium hydroxide in pulp capping procedure: (i) high-speed carious enamel removal with a round diamond bur; (ii) dentine mechanical curettage with a low-speed powered tungsten carbide bur (H1 314 014 or H1 314 012, Dentsply, Maillefer, Tulsa, OK, USA); (iii) manual nal dentine curettage using a spoon excavator (no 49, 61 or 73, Dentsply, Maillefer) making it possible to see the pulp by transparency MTA powder was mixed with sterile water in a 3 : 1 ratio, placed on the operative site with plastic amalgam carrier-like instruments (MTA Gun) and applied by light pressure with moist cotton pellets. Hard-setting calcium hydroxide paste (Dycal) was mixed according to the manufacturers instructions and applied to the sites with ball-ended instruments. Glass ionomer cement (GC Fuji IX, GC EUROPE, Leuven, Belgium) was placed over both materials as a lling material during the 6-month evaluation period of the study. The nal restoration was placed over the glass ionomer after 6 months, with either amalgam or composite following the study period A simple randomisation was used with a single sequence of random assignment, without any restriction.The rst tooth was randomly assigned to MTA and the 30 following cases were alternatively assigned to either calcium hydroxide or MTA. Each tooth was secondarily paired with a control case with the other pulp-capping material. The two paired cases differed only by the pulp-capping material (MTA or calcium hydroxide) and were paired for the type of tooth (premolar, molar), age range (as shown in Table 1) and gender of the patient. Table 2 displays the tooth distribution and sites of the initial carious lesions. Occlusal lesions represented 45% of the sample, and proximal lesions made up 55%; upper premolars and first lower molars accounted for 58% of the total treated teeth. Clinical and radiographic follow-ups were carried out at baseline, 3 and 6 months. The treatment was considered to be clinically successful when the pulp remained vital with a normal response to thermal and electrical tests without signs of spontaneous pain. The treatment was considered to be radiographically successful when the dentine bridge was present over the Table 2 Distribution of teeth according to the site of caries
Tooth type Occlusal n Upper premolar Lower premolar 1st upper molar 1st lower molar 2nd or 3rd upper molar 2nd or 3rd lower molar Total
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lesion and no furcation radiolucency, periodontal ligament space widening, internal or external root resorptions were noted. The study and recruitment of the patients were carried out from 21 May 2007 to 31 December 2008; the study was terminated 6 months later (June 2009) following the last follow-up of the nal patient. Radiographic assessment of the dentine thickness All measurements of dentine thickness were performed with Mesurim Pro Software (J-F. Madre, Academy of Amiens, Amiens, France). This software is intended to collect data on digitised images (e.g. counting of elements on an image, measurements of surface light or length). A 1-mm FixottEverett grid (FixottEverett X-Ray Grid Large Ea, Miltex Instrument Co, Inc., York, PA, USA) was used. The FixottEverett grid (Figure 1) is a metallic incorporated device placed in contact with the X-ray film during exposure, and results in a grid of known size being imaged. It was used for radiological scaling for standardised measurements on the digitised images. All the radiographs were subsequently scanned and transferred to the computer for digital analysis. Measurements on the digitised radiograph were performed at baseline (after the indirect pulp-capping procedure) and at 3 and 6 months. On each digitised radiograph, the scale for the measurements was determined using the space between two lines of the grid, which was assigned a value of 1 mm; the dentine thickness on each lm was measured with Mesurim Pro software accordingly to this scale calculation. The range of measurements was 10)3 mm. The measurements on the digitised images were performed by one investigator in this study (HMB) who was blind to the clinical procedure and the nature of the pulp-capping material. Statistical analysis Statistical analysis was performed using SPSS software (version 11.0 for Windows, SPSS Inc., Chicago, IL,

Site of caries Mesio-occlusal (%) (3.33) (0) (3.33) (23.33) (8.33) (6.66) (45.0) n 2 0 5 1 0 2 10 (%) (3.33) (0) (8.33) (1.66) (0) (3.33) (16.7) n 14 2 2 2 0 3 23 Disto-occlusal (%) (23.33) (3.33) (3.33) (3.33) (0) (5.00) (38.3) 18 2 9 17 5 9 (60) n

Total (%)

2 0 2 14 5 4 27

(30.00) (3.33) (15.00) (28.33) (8.33) (15.00) (100)


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Leye Benoist et al.


Randomized (n = 60 teeth)

Allocated to mta group n = 30

Allocated to calcium hydroxide group n = 30

Figure 1. FixotEverett grid and intrabuccal radiographic lm.

3 months lost to follow-up = 1 success = 28 fail = 1 analyzed = 30 none excluded

3 months lost to follow-up = 4 success = 22 fail = 4 analyzed = 30 none excluded

USA). Cohens kappa statistic test for qualitative measurements was used to assess the reliability of electrical pulp testing (K = 0.624, substantial agreement according to Landis and Koch27); it was also used for the intra-class correlation coefcient (ICC) for the reliability of the radiographic measurements employing Mesurim Pro Software (quantitative) with two-way random single measures (consistency based on absolute agreement) [ICC = 0.722; condence interval (CI), 0.575; 0.824; P < 0.001]. Losses to follow-up were analysed as intention to treat, i.e. regarded as failures. Means and proportions for personal characteristics and clinical parameters were calculated for both groups. The signicance of any difference in the means was tested using Students ttest, and the significance of any difference in proportions was tested using Pearsons chi-squared test. The relationship between the independent variables and the pulp-capping outcomes, considered as a dependent variable, was assessed using multivariate logistic regression analysis on subject-based data. The variables which were statistically insignificant in univariate analysis were not considered for further analysis. Statistical significance was defined as P < 0.05. RESULTS Failure and success rates The failures were dened as negative pulp vitality tests on examination. As illustrated in the ow diagram of the trial (Figure 2), at 3 months, there were four failures in the calcium hydroxide group and one in the MTA group. One additional failure at 6 months was found in the MTA group. At 3 months, the success rate was 93.1% for MTA and 73.3% for calcium hydroxide, whereas, at 6 months, it was 89.6% for MTA and remained unchanged for calcium hydroxide (Figure 3). At 3 months, the rate of failure was four times greater
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6 months lost to follow-up = 0 success = 27 fail due to lost of restoration = 1 analyzed = 30 none excluded

6 months lost to follow-up = 0 success = 22 fail = 0 analyzed = 30 none excluded

Figure 2. Flow diagram of trial.

100 90 80 70
Percent

Positive vitality test Negative vitality test

60 50 40 30 20 10 0 93.1 73.3 26.7 6.9 MTA Ca(OH)2 Success rate at 3 months 10.4 MTA Ca(OH)2 Success rate at 6 months 89.6 73.3 26.7

Figure 3. Success rates at 3 and 6 months according to the pulp-capping material.

with calcium hydroxide than with MTA, which was statistically significant (P = 0.02). After 6 months, with one additional failure in the MTA group, the difference between the two groups was not significant (P = 0.63). Newly formed dentine thickness The average thicknesses of newly formed dentine at 3 and 6 months are shown in Table 3. Using Mesurim Pro Software, at 3 months, the measurements were 0.121 0.050 mm in the MTA group and 0.136 0.060 mm in the calcium hydroxide group (P = 0.380). At 6 months, the averages were 0.235 0.110 mm in the MTA group and 0.221 0.059 mm in the calcium hydroxide group (P = 0.594). In each group, the thickness of the dentine bridge at 6 months was approximately two-fold higher than that at
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MTA versus calcium hydroxide in pulp capping Table 3 Average thicknesses of tertiary dentine at 3 and 6 months according to the pulp-capping material
Pulp-capping material MTA n Mean (mm) SD (mm) Ca(OH)2 n Mean (mm) SD (mm) Follow-up duration 3 months 28 0.121 0.059 22 0.136 0.060 6 months 27 0.235 0.110 22 0.221 0.059 t-test* P value 0.000 t-test P value <0.0001

Table 5 Multivariate logistic regression analysis with predictive factors as independent variables and pulpcapping outcome as dependent variable
Variable B SE Signicance Exp(B) or OR 0.003 0.013 0.120 6.489 95% CI Lower Upper 0.029 0.495

Disto-occlusal )2.123 0.724 caries MTA 1.870 0.754

1.481 28.439

0.000

CI, condence interval; MTA, mineral trioxide aggregate; OR, odds ratio; SE, standard error.

MTA, mineral trioxide aggregate; SD, standard deviation. *t-test between male and females in each pulp-capping material group. t-test between male and females in two pulp-capping material groups.

3 months, with a statistically significant difference (P < 0. 0001). Statistical analysis Logistic regression analysis was performed to obtain a predictive model for the pulp-capping outcome. Univariate analysis of the personal characteristics and clinical parameters showed that only the disto-occlusal site of caries and the type of capping material may affect the pulp-capping outcome (Table 4). Multivariate logistic regression analysis showed that only MTA and the disto-occlusal site of caries (independent variables) were predictive factors for the pulp-capping outcome as dependent variable. The odds ratio (OR) from the logistic regression showed the effects of the selected independent variables (Table 5). The distoocclusal site appeared to be an unfavourable factor and showed (B = )2.123) the strongest evidence as an Table 4 Univariate analysis of the effects of personal characteristics and clinical parameters on the pulp-capping outcome
Variable Age Gender Tooth localisation Tooth type Upper premolar Lower premolar 1st upper molar 1st lower molar 2nd or 3rd upper molar 2nd or 3rd lower molar Site of caries Occlusal Mesio-occlusal Disto-occlusal Pulp-capping material Ca(OH)2 MTA MTA, mineral trioxide aggregate.
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explanatory variable (P = 0.003). The final predictive model showed that the success of the pulp-capping procedure can be predicted up to 43.8% of times when MTA is used, and that failure can be predicted up to 90.9% of times when the carious lesion is on the distoocclusal site of the tooth. DISCUSSION This study was designed as a prospective, randomised, paired clinical study. The patients were young, reecting the youth of the Senegalese population, and the recruitment of patients at our institution. With regard to the operating protocol, we placed a glass ionomer cement over the capping material, which was used as restoration material during the time of the study; thus, electrical pulp testing for vitality could be performed accurately during the follow-up period. Following the pulp-capping procedure, bacterial leakage through the nal restoration material is considered to be more detrimental to the outcome than bacterial contamination at the time of treatment28. This nding underlines the need for a good seal in the nal restoration material after the completion of the pulp-capping procedure. In this study, failure occurred in one case in the MTA group, because of the loss of the restoration material. As MTA and calcium hydroxide can be distinguished by the operator on performing the pulp-capping procedure, a double-blind clinical trial could not be performed here. The success rates were comparable for MTA and calcium hydroxide at 6 months, but they differed at 3 months. Thus, the critical period for the success of the capping procedure seems to be within the rst 3 months. When looking at these success rates, and with regard to the potential toxic effects of the capping materials, we considered, as reported by Pashley 29, that there was no difference between direct and indirect pulp capping for the restoration of deep cavities, because of the fast increase in dentine permeability near the pulp. In deep cavities with a residual thickness of dentine of less than 0.5 mm, the number and size of open tubuli are such that communication with the pulp is comparable with that of a true pulp exposure 30.
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Score 0.179 0.302 0.075 4.156 0.752 1.310 0.091 1.983 0.107 3.526 1.705 8.539 5.455 5.455

df 1 1 1 1 1 1 1 1 1 1 1 1 1 1

P value 0.672 0.582 0.785 0.041 0.386 0.252 0.762 0.159 0.744 0.060 0.192 0.003 0.020 0.020

Leye Benoist et al. The 93% success rate at 3 months with MTA is in accordance with the results obtained by Bogen et al.19 in a 9-year follow-up study of direct pulp capping among 40 patients aged between 7 and 45 years; they reported successful pulp capping in 49 of 53 teeth (97.96%) on the basis of radiographic criteria, subjective symptoms and cold testing of pulp vitality. In another clinical and radiographic, 24-month, followup study of direct pulp capping on temporary molars, Tuna and Olmez31 recorded good results for both MTA and calcium hydroxide (up to 100%). The good clinical success rates are related to the thickness of the newly formed dentine. In a reference study using calcium hydroxide, Stanley et al.32 showed that the thickness of the dentine bridge did not exceed 250 lm after 66 days, and reached up to 0.5 mm after 200 days. In our study, average thicknesses of the dentine bridge were two-fold lower than those estimated by Stanley et al. 32. This difference could be related to direct or indirect capping and the assessment of the newly formed dentine thickness. In addition, our measurements were made radiographically at baseline, 3 and 6 months, whereas Stanley et al.32 measured histological cuts of dentine formation. The thickness of the newly formed dentine, using MTA as a pulpcapping material, was not documented. In this study, we found a slower formation of the dentine bridge from baseline to 3 months in the MTA group than in the calcium hydroxide group. Between 3 and 6 months, this difference was not maintained, and no difference was found at 6 months. This could be explained by the fact that MTA serves as a reservoir for calcium hydroxide and the calcium release from MTA materials decreases slightly over time1. The clinical and radiographic data reported here may be related to the cellular and biomechanical mechanisms of reparative dentine formation. Calcium hydroxide promotes the dentine repair of pulp wounds, and the presence of supercial pulp tissue necrosis is crucial and serves as a stimulus for the initiation of the hard tissue repair process2. Calcium hydroxide has the ability to dissolve the dentine, and thus gradually release growth factors33. MTA does not contain calcium hydroxide but, after hardening, calcium oxide is formed that can react with tissue uids to give calcium hydroxide18; this can induce the secretion of bronectin by the pulp cells adjacent to the necrotic layer under the capping material34. MTA is able to stimulate reparative dentine formation by the stereotypic defensive mechanism of early pulp wound healing26. The liberation of dentine factors by MTA has been demonstrated, but at different concentrations to those released by calcium hydroxide35. These differences could account for the different kinetics of dentine formation in our study, and may lead to dentine bridges
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of different quality; the quality of the newly formed dentine is a signicant factor for the success of the capping procedure. Histological studies have shown a greater frequency of inammatory cells and zones of pulp necrosis when calcium hydroxide is used for capping1316,36. In vivo studies have shown that MTA induces the formation of a high-quality thicker dentine bridge15,16,37. In this study, logistic regression analysis identied two variables predictive of the capping outcome. In the nal predictive model, MTA was signicantly predictive of the success of pulp capping and a disto-occlusal site of caries signicantly increased the risk of failure. The difcult visual access and control of dentine curettage in some areas of the teeth and the better quality of the dentine bridge and sealing ability of MTA support these ndings13,15,16,37. Other predictive models for pulp capping have emphasised age as a dependent variable for success of the procedure. This was not apparent in the logistic regression analysis performed in this study, as the sample population was homogeneous for age and mainly involved young adults; these cases are easily managed and inammatory involvement is minimal, as suggested by bleeding that is easy to stop 2. Further clinical studies need to be performed on a larger sample in order to check whether the disto-occlusal site of caries is a predictive, and not operator-dependent, factor. As no detrimental effect was demonstrated with MTA, its use may appear to be of long-term benet. Further generalisability of these results will require a larger sample and longer follow-up duration. CONCLUSION Based on the results of this short-term clinical and radiographic study, a higher success rate was observed in the MTA group relative to the Dycal group after 3 months, which was statistically signicant. After 6 months, however, no statistically signicant difference was found in the dentine thickness between the two groups. Additional histological investigations are needed to support these ndings. Acknowledgements The authors thank Dr Papa Ibrahima Ngom, Associate Professor in Orthodontics at University Cheikh Anta Diop, Dakar, Senegal, who performed statistical analysis, and Roland Arsan for the gracious provision of products that enabled this study to be conducted. Conicts of interest This study was not nanced by any company or manufacturer and has no commercial aim.
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MTA versus calcium hydroxide in pulp capping REFERENCES


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Correspondence to: Dr Fatou Leye Benoist, Institute of Dentistry, Service of Conservative Dentistry and Endodontics, University Cheikh Anta Diop, Route de lUniversite , BP16014, Dakar-Fann 12522, Dakar, Senegal. Email: fatou.leye@ucad.edu.sn

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