|Year : 2019 | Volume
| Issue : 5 | Page : 235-243
Clinical performance of mineral trioxide aggregate versus calcium hydroxide as indirect pulp-capping agents in permanent teeth: A systematic review and meta-analysis
Govula Kiranmayi, Nazia Hussainy, Anumala Lavanya, Sannapureddy Swapna
Department of Conservative Dentistry and Endodontics, Narayana Dental College and Hospital, Nellore, Andhra Pradesh, India
|Date of Web Publication||24-Sep-2019|
Dr. Govula Kiranmayi
Department of Conservative Dentistry and Endodontics, Narayana Dental College and Hospital, Nellore 524003, Andhra Pradesh.
Source of Support: None, Conflict of Interest: None
Aims and Objectives: The aim of this study was to compare the clinical performance of mineral trioxide aggregate (MTA) and calcium hydroxide as indirect pulp-capping agents in permanent teeth. Materials and Methods: Search strategy includes randomized control trials and clinical trials from the databases of PubMed Central, Cochrane, EBSCO, and MEDLINE from January 1998 to May 2018. A total of six clinical trials that met all inclusion criteria were included in this systematic review. Meta-analysis was performed for three among the included studies. The primary clinical outcome of the included studies was to evaluate the pulp vitality with a normal response to thermal, electrical, and tactile tests without signs of spontaneous pain. The radiological outcome was to evaluate the absence of periapical radiolucency, periodontal ligament space widening, and the dentin bridge formation. The primary and predominant results were assessed based on the success or failure of pulp capping. The restorations were considered failure when there are clinical symptoms such as pain and tenderness and radiographic evidence of radiolucency in periapical region or widening of periodontal ligament. Results: In the six trials that are included, two studies are judged as low risk and four as medium risk of bias. With the help of meta-analysis, the evidence produced concluded that after six-month and one-year follow-up there was no statistically significant difference between MTA and calcium hydroxide as an indirect pulp-capping material. Conclusion: This systematic review of the available evidence reveals that MTA and calcium hydroxide demonstrated good consistent endurance in clinical studies and indistinguishable performance.
Keywords: Calcium Hydroxide, Deep Carious Lesion, Dentin Bridge, Mineral Trioxide Aggregate, Reparative Dentin
|How to cite this article:|
Kiranmayi G, Hussainy N, Lavanya A, Swapna S. Clinical performance of mineral trioxide aggregate versus calcium hydroxide as indirect pulp-capping agents in permanent teeth: A systematic review and meta-analysis. J Int Oral Health 2019;11:235-43
|How to cite this URL:|
Kiranmayi G, Hussainy N, Lavanya A, Swapna S. Clinical performance of mineral trioxide aggregate versus calcium hydroxide as indirect pulp-capping agents in permanent teeth: A systematic review and meta-analysis. J Int Oral Health [serial online] 2019 [cited 2020 Sep 26];11:235-43. Available from: http://www.jioh.org/text.asp?2019/11/5/235/267707
| Introduction|| |
The conventional management of any type of carious lesion is the complete removal of infected and affected dentin, thus preventing further cariogenic activity and providing a mineralized base for dentin followed by restoration. However, when the carious lesion is extensive the treatment becomes less predictable. The deep carious lesion is clinically managed in two ways: one is by preserving the tooth vitality in the form of direct and indirect pulp capping (IPC) and the other is by performing root canal therapy. A conservative approach such as pulp capping can produce a favorable prognosis for pulp healing. According to Zanini et al., the success of IPC relies on the formation of a hard tissue barrier to protect the underlying pulp tissue. Other factors that contribute to the success of pulp-capping procedure include the type of capping material, the age of the patient, periodontal condition of the tooth, and root formation.
IPC is a procedure same as indirect pulp treatment (IPT) in which a material is placed on a thin partition of remaining carious dentin that, if removed, might expose the pulp in immature permanent teeth. Two conservative procedures have been suggested in order to avoid pulp exposures: the one- or two-step IPT and the stepwise selective caries excavation. The ultimate objective is to arrest the active carious lesion. A substantial number of materials are available to use in the treatment of the deep carious lesion., Among the available materials, calcium hydroxide (CH) is considered to be traditional and regarded as the universal standard for the vital pulp therapy materials. Desirable characteristics of CH include initial high alkaline pH, which is responsible for stimulating fibroblasts and enzyme systems. CH acts by promoting the pulp tissue defense mechanism and repair by initial matrix formation by newly differentiating odontoblast type cells, the proliferation of extracellular matrix vesicles, and subsequent calcification followed by mineralization process.,
The drawbacks of CH comprise weak marginal adaptation to dentin, degradation and dissolution over time, and primary tooth resorption leading to degradation. Reparative bridge formation subjacent to CH can also characterize tunnel defects. Histologically CH demonstrates cytotoxicity in cell cultures and induces cell apoptosis. However, long-term clinical studies have shown that CH products are resorbable over time and dimensionally unstable. The slow disintegration of the CH after hard tissue barrier formation may provide the pathway for microorganisms through calcific bridge defects in turn leading to pulpal degeneration, potential dystrophic calcifications, and pulpal necrosis.,,,
Mineral trioxide aggregate (MTA) is relatively a novel pulp-capping agent. MTA stimulates hard tissue formation by sequestering growth factors and cytokines embedded in the surrounding dentin matrix. MTA demonstrates excellent marginal adaptation to dentin compared to CH. As the restoration ages, both the pulp-capping materials, MTA and CH, form thicker tertiary dentin but the completeness and thickness of dentin barrier are not correlated with clinical success. From the point of clinical success, the most important outcome is long-term pulp vitality and the absence of clinical symptoms. The choice of the pulp-capping material is critical for the preservation of the pulp vitality. However, there is still uncertainty about the comparative clinical performance of MTA and CH as pulp-capping agents. The results will assist in enlighten appraise the clinical decision-making in the choice of either of the two interventions based on different clinical situations. The aim of this systematic review was to compare and evaluate the clinical performance of MTA and CH in IPC.,,,
Henceforth, research question is “Is the performance of MTA superior to CH when used as an IPC agent in permanent teeth?”
In the problem, intervention, comparison and outcome analysis, the population is the patients with deep dental caries that required IPC in permanent teeth. Intervention of this study is MTA as IPC agent and is compared with CH as IPC agent. The primary outcome(s) is the thickness of dentin bridge formation and the secondary outcome(s) is handling of materials
Null hypothesis is that there is no difference in effectiveness and clinical performance of MTA and CH in IPC.
| Materials and Methods|| |
The detailed search strategies for the review were developed after identifying the included studies from different database sources. The MEDLINE search used the combination of controlled vocabulary and free text terms. There were no language restrictions. The search strategy was mentioned in the search flow chart [Figure 1].
Searched databases were PubMed (from January 1998 to May 2018), PubMed Advanced Search, Cochrane, EBSCO, and MEDLINE. Hand-searched journals were Journal of Conservative Dentistry, Operative Dentistry, Journal of Adhesive Dentistry, Quintessence International, Dental Materials, Journal of Clinical and Experimental Dentistry, and Journal of Dental Research.
Randomized control trials and clinical trials with studied patient of age more than 14 years having non-carious cervical lesions were included. Teeth restored with MTA and CH with outcome measures; the thickness of dentin bridge formation was considered in search inclusion criteria. Animal studies, in vitro studies and review articles were excluded.
The quality of the included articles was assessed by the authors independently according to the GRADE methods using GRADE PRO 2008. We evaluated the quality of the body of evidence as higher as shown in the grade [Table 1] by considering the overall risk of bias, directness of evidence, consistency of results, the precision of the estimates, and risk of publication bias.
The success in the included six trials measured on an ordinal scale is a binary outcome. The odds ratio (OR) was calculated as a measure of effect size when comparing between MTA and CH. The design of all the six studies is presented in [Table 2].
| Results|| |
A single operator carried out the pulp-capping procedures in participants using both MTA and CH, and they were asked to report for the follow-up period of minimum six months and one year to assess the success. The extracted data are mentioned in detail in [Table 2]. The data obtained include the name of the first author, year of publication, patient’s information (number), study design, follow-up time, and dropout.
In the six included studies, all the included studies were compared between the CH and MTA with different follow-up time, baseline, 3, 6, 12, and 24 months. All the studies evaluated the thickness of tertiary dentin formed and the periapical radiolucency radiographically after pulp-capping procedure. One of the included studies used cone-beam computed tomography (CBCT) for assessing the thickness and type of tissue formed after the IPC. These details are presented in [Table 3].
Clinical and radiographic assessments of outcome were carried out by calibrated examiners at certain time points immediately after the pulp capping, at six months recall. The principal results assessed were the success or failure of pulp capping. Failures were considered when there were clinical symptoms such as pain, tenderness, and radiolucency in the periapical region including the widening of periodontal ligament. All the six studies evaluated the thickness of tertiary dentin formed after IPC by tooth sensibility tests, pain evaluation by visual analog scale, percussion test, and radiographically assessed the presence or absence of periapical radiolucency and thickness of tertiary dentin after IPC procedure.
Assessment of risk of bias of the included studies
Two authors independently assessed the risk of bias in the selected six trials using the Cochrane Collaboration tool for risk assessment. The following domains were evaluated and classified as low, moderate, high, or unclear risk of bias:
Blinding of participants
Incomplete outcome data
Selective outcome reporting
All the six investigators randomized participants to interventions with a block of four to six, the sequence generation judged as being at low risk of bias [Figure 2]. Among the six trials included, Mathur et al. and Petrou et al. concealed the allocation sequence.
Blinding of participants or the trial investigators and outcome assessors were reported in the studies by Agrawal et al., Sultana et al., and Leye et al. Blinding of outcome assessors was not mentioned in the studies by Mathur et al., Petrou et al., and Vural et al., which made this review at a moderate risk of performance bias. This is the risk of bias calculated by using review manager risk bias tool.
The description of dropouts was made clear in the trials done by Mathur et al., Petrou et al., and Leye et al. and the number of dropouts was just mentioned in the experiments by Vural et al., Agrawal et al., and Sultana et al. The risk of bias of all the six included articles was considered as moderate risk.
The success of the IPC measured clinically and radiographically during and after a follow-up period of minimum six months of the review was analyzed and reported in the results [Table 3].
In the study by Mathur et al. and Petrou et al., there were no failures in both MTA and CH groups after six-month follow-up period. In a study by Vural et al., in MTA group there were no failures, but in CH group there were two failures. In a study by Petrou et al., there were no failures in CH group but one in MTA group. In a study Sultana et al., there were six failures in CH group and one failure in MTA group. In a study by Leye et al., there were eight failures in CH group and three failures in MTA group after six-month follow-up.
We categorized and reported the overall risk of bias of the included studies as medium risk (medium risk of bias is a plausible bias unlikely to alter the results seriously). All domains assessed as at a medium risk of bias and it represented in risk of bias and in risk of bias summary graph [Figure 2].
The outcome measure represents the binary data that are success or failure and presence or absence of tertiary dentin. The six studies were homogeneous as the two groups, interventions and comparison, were common in all the six trials, and it was mentioned in the forest plot also as I2 56% at six months (forest plot 1, [Figure 3] for dichotomous data in the form of risk ratio at six months) and similarly 63% (forest plot 2, [Figure 4]) for dichotomous data in the form of risk ratio at one year. The pooled estimate represented in the form of diamond is crossing the center line of no effect, thus concluding that there was no significant difference in the rate of clinical success of the interventions and comparison groups. Risk difference was 1.06 (95% confidence interval [CI]) P = 0.020. On the basis of these data, there is no difference in the clinical success between the two treatment regimens. The pooled estimate represents the risk ratio, which was a relative risk of two probabilities, that is, intervention and comparison groups.,
The meta-analysis of six studies showed that the MTA was 1.06 times more successful than the CH cement (95% CI = 0.97–1.16; P = 0.020). The P-value analysis concluded that there was no significant difference between the two groups using the random effects model using Review manager 5.3 by Cochrane community.
The forest plots 1 and 2 (blobbogram) represent the graphical display of the estimated results from the six included clinical trials after six-month and after one-year follow-up period.
| Discussion|| |
The aim of the review was to provide guidelines for the clinician in choosing capping materials, MTA and CH. All the six studies comparing the two capping materials met the inclusion criteria. Both CH and MTA were found to be equally suitable for IPC based on the clinical and radiographic criteria. The success rate of CH and MTA was found to be more than 95%. The success of IPC relies on thickness, type of tissue formed, and tertiary dentin which in turn evaluated by intraoral periapical or panoramic imaging but with several limitations as they are only two dimensional. According to Mathur et al. with the Hounsfield units in CBCT, there were more chances to analyze the type and quantity of tissue formed with pulp capping regarding radiodensity. Increase in radiodensity at six-month follow-up was almost equal in the two groups. Stanley et al. stated that there was no significant difference between the two groups. There was a specific radiodense material deposition in both the groups.
The blinding of outcome assessors was not mentioned explicitly in all the six included studies; henceforth, the detection bias was unclear in this review. The allocation concealment, which is supposed to be a valuable step in reducing the selection bias, was not specified in four of the included studies conducted by Fataou et al., Marina et al., Rafeza et al., and Vural et al. In all the included six trials, the survival rate of pulp-capping materials was determined by the tooth sensibility tests. These precise tests helped in the assessment of the primary outcome, missing data to follow-up, and the final disposition of missing participants, which comprises additional indicators of the intervention bias effect. Overall, the included six studies were at moderate risk of performance and attrition bias.
The main purpose of all the six studies included in this review was to evaluate the comparative success or failure of the two interventions. To explore the longevity of capping materials usually a longer follow-up period would normally be required, so the investigators included six-month and one-year follow-up period.,, The difference in the failure rate was not noteworthy between the two interventions.,, There are many reviews and evidence-based summaries, which largely agree with the conclusions in this systematic review that there was no clear evidence of any difference in the success rates of MTA.,, The results of the six clinical trials considered in this review provided valuable information and high-quality evidence for the intervention effect. This systematic review was the first one to put all these data together and get the meta-analysis despite high heterogeneity of data, which was the first step to resolve the conflict in this area of (pulp capping) conservative dentistry.
Meanwhile, it proved that there was no significant difference between the two materials using the random effects model (OR = 1.06; 95% CI = 0.97–1.16; P = 0.20).
The studies included a follow-up of six months and three of them till one year and were assessed to be at medium risk of bias as the blinding of outcome assessors was not mentioned in three of the studies as a limitation of this study.
The evidence produced from the six included studies concluded that after six-month and one-year follow-up, there was no statistically significant difference between MTA and CH as an IPC material. The quality of evidence of this review was high as the six included studies are at medium risk of bias. Future research should aim to provide more reliable information that can help clinicians to decide on appropriate treatment while taking into consideration the individual circumstances and preferences of their patients.
| Conclusion|| |
All the participants included in the six trials of this review were judged to be at medium risk of performance detection and attrition bias. Therefore, there was clinically reliable evidence from this review to determine whether CH or MTA as an IPC material can provide enough clinical and radiographical success minimum for six months and also up to one year. In consideration of this systematic review and meta-analysis, more studies are advocated to assess the long-term follow-up period concerning the success rate of the IPC materials. However, more extensive, blind, randomized controlled trials are to be conducted to provide more reliable clinical evidence.
This review has been registered in PROSPERO International prospective register of systematic reviews on July 19, 2018 with the registration number CRD42018096404. All six included randomized clinical trials were approved and registered by their corresponding institutional ethical committees and institutional review boards.
The data set presented within this manuscript has been obtained from the six included articles. The data were readily available within the articles.
We would like to thank Richard Kirumbakaran, research scientist (biostatistics) Cochrane South Asia, and the peer referees for his contribution in conducting the original systematic review and meta-analysis. We also would like to acknowledge the contribution of our head of the department, senior staff members, and colleagues.
Financial support and sponsorship
Conflict of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3]