Comparative evaluation of biodentine and endosequence root repair material as direct pulp capping material: A clinical study.

Aim: The study was designed to clinically evaluate biodentine and endosequence root repair material (ERRM) as direct pulp capping agent at 3 months, 6 months, and 12 months intervals. Materials and
Methods: Sixty permanent posterior teeth with deep caries, without any signs of irreversible pulpitis were allotted into two experimental groups: Group I -Biodentine, Group II-ERRM. Follow-up evaluations were done. Every 24 h for 7 days, the pain was assessed using visual analog scale. Statistical Analysis: Paired t-test along with Pearson's Chi-square test was performed.
Results: The success rate of clinical assessment at 12 months for biodentine group is 78.60% and ERRM Group is 64.70%.
Conclusion: Biodentine group performed superior than ERRM group clinically at all-time interval and hence it can be successfully used to restore exposed vital tooth. Copyright:

INTRODUCTION

Vital pulp therapy can be generally demarcated as “Any aspect of restorative dental management which is proposed to reduce trauma to the dental pulp tissue.”[1] direct pulp capping can be performed whenever the tooth shows signs of reversible pulpitis which can produce “reparative dentin” there by protecting from further insults.[2]

Conventionally, calcium hydroxide (Ca (OH)2) has been used extensively as direct pulp capping agent because of its high pH (12.5), which forms bridge over the dentine but one of the drawback of Ca (OH)2is that it provides a poor seal to the exposed pulp.[34] Some of the investigators also asserted the need to consider alternatives to Ca (OH)2as this bridge fails to seal the pulp because of tunnel defects leading to the microleakage.[5] It was also noted that Ca (OH)2has a propensity to dissolve and degenerate leading to voids creating pathways for microorganisms. Hence, it is not regarded as an ideal pulp capping material.[6]

Biodentine was introduced as a dentine substitute having Active Bio-silicate Technology. It is bioactive and the biocompatible, used as a material of choice for the pulpotomy and pulp capping material. Other than improved strength biodentine has a benefit of less setting time of 10–12 min as compared to MTA which has 2–3 h.[78] It has similar mechanical properties to that of the dentin. On vital pulp cells, it has a positive effect and promotes reparative dentin formation.[910]

Over the past decade, new developments have been seen, especially in bioceramic nanotechnology, which lead to the introduction of a novel bioceramic material “Endosequence root repair material (ERRM)” (brasseler, Savannah, GA, USA).[11] It is described as a hydrophilic, insoluble, radiopaque and aluminum-free ready to use material supplied as a premixed product in both low and high viscosity form recommended for pulp capping, perforation repair, apical surgery, and apical plug. It consists of Tantalum Oxide, Calcium Silicates and Calcium Phosphate Monobasic, Zirconium Oxide, Filler and thickening agents. Moisture is necessary for the materials to harden and set. It has Working time ≥30 min and setting time 20 min to 2 h depending upon viscosity of the material. It has high pH value (12.5), biocompatible and antibacterial properties.[1112]

Very scarce scientific literature available on evaluating biodentine and ERRM in deep carious teeth. Hence, the purpose of this research was to evaluate the incidence of postoperative pain after direct pulp capping with biodentine and ERRM at Baseline, 3, 6, and 12 months' intervals. The null hypothesis (H0) considered that there was no difference among Biodentine and ERRM as direct pulp capping materials.

MATERIALS AND METHODS

After obtaining approval from the Institutions Human Ethics Committee, University-Protocol number SVIEC/ON/Dent/BNPG-16/D17012 was obtained and study was designed in accordance with the 2010 CONSORT guidelines.

Patient's age 18–40 years with deep carious lesion who were referred to the department for the management of teeth with deep carious lesions on either the occlusal/proximal surface in their permanent posteriors teeth were included. Asymptomatic teeth with positive thermal and electrical tests with absence of tenderness, showing signs of reversible pulpitis, radiographic findings revealing the deep caries, teeth with any accidental pulp exposure and with the absence of periapical lesions were included.

Tooth with fracture, any systemic diseases or medically compromised patients, teeth with periodontal involvement, any periapical pathology, ankylosed tooth, developmental anomaly of teeth, and carious pulp exposure site >0.5–1 mm were excluded.

Before patient recruitment, the sample size was estimated following the formula suggested by Leye Benoist et al.[1] With the expectation of dropout, a 20% increase in number of samples were done and the minimum number of subjects needed for a statistical significance (P < 0.05) for final sample size was calculated as 60 using α =5% with a power of 80%, which was further divided into 2 groups of 30 samples. Patients were explained about all the procedural steps, possible complications and after that informed consent was taken.

The sterilization protocol was maintained and treatment procedure was thoroughly monitored by principal investigator. Teeth were subjected to cold, heat, electrical pulp test for vitality confirmation and all vital deep carious lesions were radiographically evaluated by taking periapical radiographs with grid using paralleling technique to confirm the extension of lesion till pulp chamber.

Application of local anesthetic agent followed by rubber dam isolation was done. Removal of caries was done with no. 4 sterile carbide round bur on a slow speed hand piece or medium sharp spoon excavator (hu-freidy, USA). Complete pulp hemostasis was achieved using a cotton pellet soaked in saline. The cavity was dried and the exposure site was covered with 1–2 mm thick layer of one of the chosen materials as per the instructions of manufacturer. Patients were randomly divided using odd-even numbering method into two groups:

Group I: Biodentine (septodont, Saint-Maur-des-Fossés Cedex, France) (n = 30)

Group II: ERRM (brasseler, Savannah, GA, USA) (n = 30).

Once the material is set, the resin modified glass ionomer cement (gc corporation, Tokyo, Japan) was placed as intermediate restorative material for 2 weeks during evaluation and replaced with composite resin (Solare X – gc corporation, Tokyo, Japan) as permanent restorative material [Figure 1]. The patient was advised to report back to the department in case of loss of intermediate restoration or any discomfort.

Figure 1

Representative case of Biodentine group: (a) Preoperative clinical photograph, (b) Exposure of pulp, (c) Placement of Biodentine over the exposure site, (d) Evaluation after 6 months and restoration with resin-modified Glass ionomer cement (GIC) as base and Final restoration with Composite. Representative case of Endosequence Root Repair material group: (e) Preoperative clinical photograph, (f) Exposure of pulp, (g) Placement of Endosequence Root Repair material over the exposure site, (h) Evaluation after 6 months and Final restoration with Composite

After completing all the Clinical procedure, a periapical radiograph was taken as a baseline for further follow-ups and for assessment of dentin bridge formation at 3, 6, and 12 months. Clinical and radiographic investigations were carried out by blinded examiner at 3, 6, and 12 months. Radiographs were scanned and an increase in dentin thickness was measured through sequential imaging with the help of “Image J” image processing and analysis software (1.4 versions, Informer Technologies, Inc.).

The primary outcome was to measure the clinical success at 12-months of follow-up, and the secondary outcome was to assess intensity of postoperative pain after 7 days. Pain was documented at baseline, 6, 12, 18 h and 1, 2, 3, 4, 5, 6, 7 days after the procedure. Patients were advised to take prescribed analgesic if they experienced pain and to record their pain score according to the visual analog scale.[13] The patient and examiner were blinded about the types of capping material which was used.

Statistical analysis

SPSS Version 20.0 (Armonk, NY, USA: IBM Corp) was used for analysis of the collected data. PAIRED t-test with Pearson's Chi-square test was used for analysis wherein P value for the statistical significance was taken as <0.05 and <0.001 as highly significant.

RESULTS

A total of 168 patients were considered for the initial recruitment out of which 108 participants got rejected because of nonexposure of pulp upon caries excavation and not meeting inclusion criteria. Consequently, 60 subjects were eventually included after making allowance for the drop outs [Figure 2].

Figure 2

Flow chart of the subjects included and their progress throughout all the phases of study

The success rate of clinical assessment at 12 months for biodentine group is 78.60% and ERRM Group is 64.70%. At 3, 6, and 12 months. The rate of failure and intensity of postoperative pain with biodentine and ERRM was not statistically significant at all the intervals [Table 1]. Vitality assessment also revealed an insignificant difference between both the groups.

Table 1

Chisquare tests for clinical evaluation for comparison of the two groups

GROUP		Percussion Test					Heat test				Cold test				Electric test
		n (%)	baseline	3 months	6 months	12 months	baseline	3 months	6 months	12 months	baseline	3 months	6 months	12 months	Baseline	3 months	6 months	12 months
GROUP A	POSITIVE	0 (0)	0 (0)	0 (0)	0 (0)	VITAL	28 (100)	22 (91.70)	21 (100)	21 (100)	30 (100)	22 (91.70)	21 (100)	0 (21 (100)	30 (100)	22 (91.70)	21 (100)	21 (100)
	NEGATIVE	30 (100)	21 (100)	21 (100)	21 (100)	NON VITAL	0 (0)	2 (8.30)	0 (0)	0 (0)	0 (0)	2 (8.30)	0 (0)	0 (0)	0 (0)	2 (8.30)	0 (0)	0 (0)
GROUP B	POSITIVE	0 (0)	0 (0)	0 (0)	0 (0)	VITAL	30 (100)	19 (100)	19 (100)	17 (100)	30 (100)	19 (95.00)	19 (100)	17 (100)	30 (100)	19 (95.00)	19 (100)	17 (100)
	NEGATIVE	30 (100)	25 (100)	21 (100)	17 (100)	NON VITAL	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (5.00)	0 (0)	0 (0)	0 (0)	1 (5.00)	0 (0)	0 (0)
	Chi - square								1.661				0.191				0.191
	P								0.198				0.662				0.662

DISCUSSION

Inadequate evidence is available for use of bioceramics as pulp capping procedures in adult population. No reported randomized clinical trials were found, which compares biodentine and ERRM as direct pulp capping materials. Premixed bioceramic materials are advocated for pulp capping procedure due to their improved sealing ability as well as they do not discolor the adjacent dentin. Hence, these properties of premixed bioceramic materials like ERRM make them suitable for it to be used as pulp capping agent. Many studies on premixed endodontic bioceramic materials have shown that the properties of a bioceramic material are comparable to MTA.[14]

Bhat et al. presented the use of biodentine in their case report on direct pulp capping in an immature incisor and they have concluded that it is a favorable material that had significant potential to preserve vitality of pulp in cases carefully selected for direct pulp capping.[15] Nowicka et al. compared biodentine with MTA for pulp capping in human molar teeth clinically as well as histologically and established that biodentine is as good as MTA for pulp capping treatment.[7] The dentin bridge formation induced by biodentine showed a pattern well-localized at the injury site contrasting to that caused by Ca (OH)2that showed an expanding structure in terms of the presence of tunnel defects in the pulp chamber. The quality of the formed dentin was more constructive as compared with Ca(OH)2.[6]

ERRM is a new bioceramic material which is delivered as a premixed product in low viscosity paste form dispensed from a syringe, fast-set, ready-to-use. It contains Nanosphere particles having maximum diameter of 1 × 10−3μm, which let the material to enter into the dentinal tubules, conditioned by dentin liquid and produces a mechanical bond on setting.[16] Shokouhinejad et al. established the bioactivity of ERRM by exposing the set material on phosphate-buffered saline and concluded that there was presence of precipitation of apatite crystalline structures, which shows its bioactivity. Endosequence has been shown to have negligible cytotoxicity and capability to induce cytokine expression.[17] Hence, it is a biocompatible material, with ability to form apatite to enhance formation of dentinal bridge on human dental pulp cells and other alternate human cells in vitro and in vivo studies without any severe problems.[18]

Pulp vitality assessment is one of the criteria for a successful restoration which includes cold, heat, electrical pulp test for pulp vitality confirmation. In the present study, all the samples showed vitality at baseline but after 3, 6, and 12 months of follow-up period only 21 out of 24 patients from biodentine group (Group I) and 17 out of 22 patients from ERRM group (Group II) reported positive signs of vitality. Although the difference is not statistically significant but clinically more samples of the biodentine group were showing positive signs of vitality compared to ERRM group as well as in the radiographs biodentine group samples showed an increase in dentin thickness when measured through sequential imaging with the help of “image J” software.

Ikhar et al. in their study comparing ERRM with MTA as pulp capping material concluded that though, ERRM is newer promising material but MTA produced better results.[11] Solanki et al. in their systematic review stated that the good sealing ability of MTA is related to its good biological properties.[19] Whereas Ghattas et al. concluded that when used as a retrograde filling material ERRM showed similar ability of sealing to white MTA.[20] There was no reported study on clinical assessment of ERRM as a pulp capping agent in human teeth.

In the present research, the baseline parameters did not have significant difference among the groups, thus confirming equal and homogenous distribution of the samples among two groups (successful randomization). The success rate of clinical assessment at 12 months for Biodentine group is 78.60% and ERRM group is 64.70%. Group I reported 3 failures and Group II reported 5 failures after 12 months of follow-up. The failed cases gave a negative heat test, cold test, and electric test but had no pain. For all failed cases, root canal treatment was performed.

Postoperative pain assessment was considered as secondary outcome. After confirming the insignificant difference in the baseline scores, postoperative pain amongst the groups were analyzed at 24 h, which revealed no statistical significant difference. However, in Biodentine group (22 [73.30%]) patients did not report any pain in comparison with the ERRM group (26 [86.70%]) [Graph 1]. Iwamoto et al. (2006), in their research also found similar result in favor of using bio ceramics in order to have less incidence of postoperative pain. They compared white mineral trioxide aggregate and Ca (OH)2which yielded no difference in posttreatment pain, even though a histological study indicated not as much of inflammation with MTA in comparison to Ca (OH)2.[132122] Above findings supports the outcomes of the current research for postoperative pain evaluation which was in the favor for the use of these materials.

Graph 1

Postoperative pain assessment

Studies have shown that the success rate of pulpectomy in posteriors found to be 93%, but the success rate of root canal treatment is more only if it is done by specialists than general practitioners.[2324] Hence, the relatively considerable better performance of biodentine (78.60%) and ERRM (64.70%) in the current research may also challenge the choice of treatment for exposed carious posterior tooth if specialist endodontic treatment is not accessible. It is necessary to identify whether this favorable result can be correlated to other calcium silicate materials.[25]

The limitations of the study are, the investigator cannot be blinded due to dissimilar characteristics of the materials and the relatively small sample size. Hence, randomized controlled trial with a large sample sizes and long-term follow-up are necessary to confirm the promising result of the bioceramic materials.

CONCLUSION

There was no statistically significant difference seen in the performance of biodentine and ERRM as pulp capping agent. Hence, the null hypothesis was accepted. However, a clinically better performance was noted with biodentine group at all interval of time.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.