5/23/2021 Biodentine versus mineral trioxide aggregate as a direct pulp capping material for human mature permanent teeth

material for human mature permanent teeth – A systematic review

Biodentine versus mineral trioxide aggregate as a direct pulp capping material for human mature permanent teeth – A systematic review
Salah H. Mahmoud, Salwa A. El-Negoly, [...], and Mohammed E. Grawish

Abstract

Background:
Biodentine is comparatively a new biomaterial claimed to have properties comparable to mineral trioxide aggregate (MTA). Biodentine and MTA are effectively used for direct pulp capping (DPC), and they
are capable of regenerating relatively damaged pulp and formation of hard dentine bridge.

Objectives:
The aim of this systematic review was to test the null hypothesis of no difference between Biodentine and MTA as DPC materials for human permanent mature teeth, against the alternative hypothesis of a
difference.

Data Sources:
Clinical trials were identified by electronic databases searches of Midline, CENTRAL Cochrane Library, Latin American and Caribbean Health Sciences Literature, Scopus, Scientific Electronic Library
Online, evidence-based endodontics literature, KoreaMed, and Google Scholar. The literature search was performed from January 2010 to February 2018. Hand searches were also performed for relevant
abstracts, books, and reference lists. Titles and abstracts of studies identified using the above-described protocol were independently screened by two authors. Full texts of studies judged by title and abstracts
to be relevant were independently evaluated by two authors for stated eligibility criteria.

Study Eligibility Criteria:

The eligibility criteria included randomized clinical trials (RCTs) and non-RCTs.

Participants:
Patients with permanent mature molars indicated for surgical extraction or molars that have symptomless exposure of vital pulp tissue by caries or trauma. In both cases, the molars were subjected to DPC.

Interventions:
The pulp exposures were directly treated by Biodentine or MTA.

Study Appraisal:
To assess article quality, two authors independently used the risk of bias in nonrandomized studies – of interventions.

Methods:
Qualitative metasynthesis was used to analyze data across qualitative studies.

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Results:
The initial search identified 8725 unique references through the search process. No additional studies were identified through handsearching. After filtering, 915 references were recorded and screened. After
the eligibility criteria were applied, seven unduplicated prospective and retrospective cohort studies were included in the qualitative metasynthesis.

Limitations:
Further RCTs with much larger sample size and proper methodology with longer observational time are still in need to adequately address the questions of the present systematic review.

Conclusion and Implications of Key Findings:

Within the limitations of this review, it may be concluded that Biodentine had a similar effect on dentin bridge formation likely to MTA. However, this conclusion is based on only very few well-conducted
prospective and retrospective cohort studies.

Systematic Review Registration Number:

The review had been registered with PROSPERO (registration number CRD42018089302).

Keywords: Biodentine, dentin bridge formation, direct pulp capping, mineral trioxide aggregate, permanent molars

INTRODUCTION
Pulp exposure can be due to trauma, mechanical reasons, or caries. Direct pulp capping (DPC) may be required as one of the treatment options to prevent the dental pulp from necrosis.[1] Ideal pulp capping
material should maintain pulpal vitality and stimulate reparative dentin formation.[2] These materials should possess certain properties such as radiopacity, insolubility, dimensional stability, biocompatibility,
bioactivity, and adequate adhesive ability to both the dentin and to the restorative materials.[3] It should also release fluoride, provide bacterial seal, prevent secondary caries, should have bactericidal or
bacteriostatic activity against the causative pathogens, and promote the formation of mineralized tissue.[4]

Till date, calcium hydroxide (CH), mineral trioxide aggregate (MTA), and tricalcium silicate cement (Biodentine) are the materials of choice which have been most commonly used in clinics.[5] Although
CH has been considered as the gold standard for pulp capping, it still has several drawbacks, namely, insufficient adherence to dentin, multiple tunnel defects in the dentin bridges, and dissolution over time.
[6] The two main components of MTA are calcium oxide and silicon dioxide. When these raw materials are blended, they produce tricalcium silicate, dicalcium silicate, tricalcium aluminate, tetracalcium
aluminoferrite, and other mineral oxides. Bismuth oxide was added so that the material can be detected on radiographs. On addition of water, the cement hydrates, form silicate hydrate gel.[7] Gray MTA was
the original formulation to be introduced, and white MTA was developed later as this version improved esthetics.[8]

Disadvantages of MTA are that it is highly soluble and has a prolonged setting more than 2 h.[9] Meanwhile, Biodentine is a two components material; the powder component consists of tricalcium silicate,
dicalcium silicate as a second core material, calcium carbonate, oxide as filler, iron oxide shade, and zirconium oxide as a radioopacifier. The liquid, on the other hand, contains calcium chloride as a setting
accelerator and a water reducing agent.[10] There is ample evidence for positive effects of Biodentine on vital pulp cells, for stimulating tertiary dentin formation, and early formation of reparative dentin.
[11]

The gold standard of experimental design is the randomized clinical trials (RCTs), in which participants are divided by chance into separate groups.[12] The British physician Archie Cochrane contributed
greatly to the development of epidemiology as a science, and he was concerned about the efficacy of health care. Cochrane emphasized the necessity of performing strict systematic review with high
scientific evidence from well-designed and well-conducted RCTs of medical studies to acquire a true and reliable conclusion.[13] The Oxford Centre for Evidence-based Medicine considers systematic
reviews of RCTs as Level 1 according to the levels of evidence (LoE) corresponding to study design.[14]

The rationale for conducting this systematic review arose from the fact that a reliable biomaterial for DPC may be considered as an alternative to pulpectomy, especially if the pulp status is favorable.
Biodentine has been recently introduced on the market to overcome the limitations of MTA as long setting time, poor handling properties, cost, and the potential discoloration of teeth and soft tissue.

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Accordingly, this systematic review will provide decision-making process based on scientific evidence for the clinician and health-care provider to select the material of choice as a DPC. The aim of this
study was to conduct a systematic review on the efficacy of Biodentine versus MTA as DPC materials for human permanent teeth. This objective was based on a research question; is there is a difference
between Biodentine and MTA as DPC materials for permanent mature teeth.

METHODS

Protocol and registration

The methodology of this systematic review was done on the basis of the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses checklist.[15] The review had been registered
with international prospective register of systematic reviews (PROSPERO) (registration number CRD42018089302). The clinical question was formulated and organized using the PICO strategy for the
research question construction.

Eligibility criteria
The inclusion criteria included were as follows: (1) studies are RCTs or non-RCTs; (2) all selected teeth were permanent molars with symptomless exposure of vital pulp tissue by caries or trauma; (3) the
pulp exposures were treated by Biodentine or MTA; (4) all selected teeth had a 1-month follow-up time at least; and (5) the outcome was evaluated by clinical symptoms and/or radiographic evidence. The
exclusion criteria were (1) immature teeth, (2) primary teeth, (3) studies assessed mechanical or physical properties of the materials, (4) negative control group which does not have a capping material, (5)
indirect pulp capping, pulpotomy, and pulpectomy, and (6) animal and laboratory-based studies, qualitative and/or quantitative reviews, commentaries, case reports/case series, and letters to the editor.

Information sources and search strategy

The PROSPERO and the Cochrane Database of Systematic Reviews were searched in February 2018 and presented no existing reviews that were found comparing the effect of these two materials as a DPC
for permanent teeth. To identify published clinical trials relevant to the focused question, all searches were conducted independently by two authors (MG and SE). A literature search was conducted based on
multiple electronic databases (PubMed [Midline], CENTRAL Cochrane Library, Latin American and Caribbean Health Sciences Literature, Scopus, Scientific Electronic Library Online, evidence-based
endodontics literature, KoreaMed records [KoreaMed], and Google Scholar). The literature search was performed from January 2010 to February 2018, based on a predetermined PICOS statement. The
population was adult patients; the intervention was tricalcium silicate cement/Biodentine; the comparator was MTA; the outcome was the efficacy of these two materials as a DPC; and the study designs were
clinical trials. Medical subject headings terms, “dental pulp capping” and “pulp capping and pulpectomy agents,” were used in our search. Other search words or terms were used in search strategy [Table 1].
The search strategy used in PubMed was adjusted for use in the other databases. These keywords were used with Boolean operators AND, OR, and NOT. References of the identified studies were
handsearched to identify further potentially relevant studies, relevant conference proceedings, and relevant abstracts; books as well as searching gray literatures were performed. Any disagreements in the
study selection were resolved through discussion with a third author (SM).

Table 1
Databases involved and the search terms used with the number of references obtained after filtering and applying the eligibility criteria

Study selection and data collection

Two authors (AZ and MZ) screened all the titles and abstracts and selected only studies related to DPC materials in accordance with the eligibility criteria. They independently tabulated the data of interest.
From the studies included, the following data were tabulated: authors and their country, study design, journal (year of publication), age and gender of study individuals, study groups, vital pulp treatment,
type of material evaluated, follow-up in days, and the type of teeth evaluated. Authors of the studies included were contacted through electronic mail in case data were missing or additional information

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regarding their studies was required. Fields for which information could not be found in a publication or online abstract were entered as “unknown” and were either excluded in the subsequent meta-analysis
or included as “unknown [Table 2].”

Table 2
Characteristics of the studies included

Risk of bias in individual studies

To assess article quality, two authors (SM and SE) independently used the “risk of bias (RoB) in nonrandomized studies – of interventions.”[23] It is concerned with evaluating the RoB in the results of
nonrandomized studies of the effects of interventions that compare the health effects of two or more interventions. Each criterion was rated as “Yes,” “Probably yes,” “Probably no,” “No,” and “No
information [Table 3].” For consistency, any disagreements in the assessment were resolved through discussion with a third author (MG).

Table 3
Quality assessment of included studies

Statistical analysis
Degree of chance – adjusted agreement (kappa coefficient value) was used to determine the inter-reviewer reliability.

RESULTS

Study selection
The initial search identified 8725 unique references through the search process. No additional studies were identified through handsearching. After filtering, 915 references were recorded and screened. After
the eligibility criteria were applied, seven unduplicated prospective and retrospective cohort studies were obtained and were included in the present review [Table 1 and Figure 1]. The kappa value for
interexaminer's agreements was 0.79.

Figure 1
Flowchart for article selection according to preferred reporting items for systematic reviews and meta-analyses guidelines

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Study characteristics
One study was performed in 2013 (Poland), two at 2015 (Poland and Republic of Macedonia), one in 2016 (Pakistan), and three in 2017 (India and Saudi Arabia). Six of them were prospective observational
studies while the remaining one was pilot retrospective study. Two studies were done by Nowicka et al.[16,18] evaluating the clinical and histological response of human dental pulp capped with Biodentine
or MTA. Clinical examination was done through thermal and electric testing, and in addition, plain radiographs and tomographic evaluation using CBCT imaging were performed. Histologically, they
evaluated continuity, morphology and thickness of hard tissue formation, type, intensity and extension of pulp inflammation, and other histologic features. Moreover, one study[17] carried their trial on two
levels, clinical testing and pathohistological one. The pathohistological evaluation was for dentin bridge morphology, type and intensity of pulp inflammation, and other histological features [Table 4]. The
clinical and radiological evaluations were performed after 8 and 30 days for the vitality of teeth, subjective symptoms, and amount of reparative dentin formation. The other four studies recorded the
postoperative pain of patients included using visual analog scale after 7 days, 1 month, 3 months, and 6 months. In addition, postoperative radiographs were taken on 3-month and 6-month recall visits to
detect any apical radiolucency,[19] assessed the pulpal health after 3 weeks, 3 months, 6 months, and 1 year using thermal and electrical pulp sensitivity testing, and in addition, 6-month follow-up
radiographs were taken,[20] analyzed the clinical and radiographic recall data at intervals of 1, 3, 6, 12, and 18 months. The data were comprised pain, sensibility status of the teeth, radiographic signs of
periapical pathology, and dentin bridge formation[21] and were performed clinical and radiological examination after 1-year recall.[22]

Table 4
Heterogeneity assessment of included studies

Risk of bias within studies

Heterogeneity was found between the previous studies.[16,17,18,19,20,21,22] as they used different methods of evaluation (histological, clinical, and radiological), and in addition, different scores for the
amount of dentin bridge formation were used in histological and radiological assessments. Pulp vitality was assessed with different parameters; moreover, dichotomous data were sometimes used, and in
other instances, continuous data were the main outcome. Common study limitations included inadequate randomization and allocation concealment, nonreporting of study withdrawals and participants lost to
follow-up, lack of blinding of outcome assessor, contamination, and failure to perform an intention to treat analysis. Four studies had moderate RoB, two had serious RoB, and one had critical RoB.

DISCUSSION
A systematic review, by virtue of the method used to collect information, provides a solid base for clinical decision-making, due to its high LoE. It is a systematic assessment of the available literature for the
effects of health-care interventions and is an assessment that is intended to help professionals in choosing the appropriate treatment.[24]

The main findings of the included studies were dentin bridge formation, inflammatory cell infiltration, amount of pulp necrosis, and pulp vitality. With regard to dentin bridge formation, it was found that
Biodentine and MTA are likely to promote the formation of reparative dentin, and they have positive results on odontoblasts when used in DPC. Biodentine and MTA are used in pulp capping due to their
involvement in mineralized tissue bridge formation, the preservation of pulpal vitality, and promotion of odontoblast layer integrity.[25] For health-care provider and clinicians, Biodentine is new bioactive
cement that is similar to the widely used MTA. It has dentin-like mechanical properties, which may be considered a suitable material for clinical indications of dentin-pulp complex regeneration such as DPC.

The main appeal of the RCT in health care comes from its potential to reduce selection bias. In the present systematic review, all the included studies were parallel groups without randomization and this can
be attributed to the little number of participant involved in each study. Studies with small sample sizes have a tendency to be less reliable and are more probably inconclusive due to inadequate statistical
power.[26] In addition, the study designs were based in some studies on using sound molar teeth, and in others, they depend on carious teeth. From the biological point of view, the pulp will respond
differentially in both situations even at the basis of the molecular level with differential molecular interactions that potentially affect the final outcome. The major causes of postoperative inflammation and
pulp necrosis are nonsterile procedures and bacterial micro-infiltration of the pulp through dentin tubules.[27]

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Among the drawbacks of the included studies were the short time follow-up evaluation periods. Dentin formation usually starts within 30 days of the pulp capping (there can be a delay in onset of dentin
formation if the odontoblasts of the pulp are injured during cavity removal) and is largely completed by 130 days.[28] Moreover, the size of the pulp exposure is not considerably consistent in the included
studies. The success of the pulp capping procedure greatly depends on the circumstances under which it is performed, and the prognosis depends on the age, type, site, and size of pulp exposure.[29]

The outcomes of the present systematic review should be taken with caution due to the presence of uncontrolled confounding factors in the included clinical trials. Within the limitations of the existing
clinical trials, the results of the present study suggest that the Biodentine had a similar effect on dentin bridge formation likely to MTA. However, this conclusion is based on only very few well-conducted
prospective and retrospective cohort studies.

Financial support and sponsorship

Nil.

Con icts of interest

There are no conflicts of interest.

Article information
J Conserv Dent. 2018 Sep-Oct; 21(5): 466–473.
doi: 10.4103/JCD.JCD_198_18

PMCID: PMC6161524
PMID: 30294104

Salah H. Mahmoud, Salwa A. El-Negoly,1 Ahmed M. Zaen El-Din,2 Mona H. El-Zekrid,3 Lamyaa M. Grawish,4 Hala M. Grawish,4 and Mohammed E. Grawish3

Department of Operative Dentistry, Faculty of Dentistry, Mansoura University, Mansoura, Egypt

1
Department of Dental Biomaterials, Faculty of Dentistry, Mansoura University, Mansoura, Egypt
2
Department of Operative Dentistry, Faculty of Oral and Dental Medicine, Delta University for Science and Technology, Mansoura, Egypt
3
Department of Oral Biology, Faculty of Dentistry, Mansoura University, Mansoura, Egypt
4
Department of Undergraduate Students, Faculty of Oral and Dental Medicine, Delta University for Science and Technology, Mansoura, Egypt
Address for correspondence: Prof. Mohammed E. Grawish, Faculty of Dentistry, Mansoura University, Mansoura, Egypt. E-mail: grawish2005@yahoo.com

Received 2018 Apr 23; Revised 2018 Jul 21; Accepted 2018 Jul 29.

Copyright : © 2018 Journal of Conservative Dentistry

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long
as appropriate credit is given and the new creations are licensed under the identical terms.

This article has been cited by other articles in PMC.

Articles from Journal of Conservative Dentistry : JCD are provided here courtesy of Wolters Kluwer -- Medknow Publications

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