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Year : 2019  |  Volume : 30  |  Issue : 2  |  Page : 191-195
Clinical evaluation of biodentine: Its efficacy in the management of deep dental caries

Department of Conservative Dentistry and Endodontics, Sri Rajiv Gandhi Dental College of Science and Hospital, Bengaluru, Karnataka, India

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Date of Web Publication29-May-2019


Background: The advancement in the dentin regeneration aiming at the preservation of pulpal vitality has challenged the traditional concept of substituting diseased tooth with inert materials. Clinical studies, demonstrating preservation of pulpal vitality with the use of biomimetic materials in deep carious lesions, are lacking in the literature. Objective: This clinical study aims to assess the treatment outcome of vital pulp therapy using Biodentine in cases of deep carious lesion in a single visit treatment protocol. Methodology: Twelve posterior teeth with deep carious lesion with no signs of irreversible pulpitis were selected for the study. After rubber dam application, excavation of caries was performed until all infected dentin was removed leaving behind affected dentine. Biodentine was applied followed by immediate restoration with bonded composite resin. The patient was recalled at time intervals of 1 day, 1 month, 3 months, 6 months and up to 1 year for clinical and radiographic evaluation. Outcome was described in terms of success and failure. Success was defined as clinical absence of signs and symptoms, response to sensibility test on every recall visits, no tooth discoloration seen, and radiographical absence of periapical pathosis. Results: All the 12 patients were recalled at the end of 1 year for follow-up. The overall success rate was 83.4%. Two of the twelve cases required root canal treatment to relieve painful pulpitis. On clinical and radiographic examination, no signs of periapical pathosis were noted in the 10 successful cases. Conclusion: In deep carious lesions, vital pulp therapy with Biodentine has proven to maintain the pulpal vitality in permanent teeth with single visit treatment protocol.

Keywords: Biodentine, deep carious lesion, vital pulp therapy

How to cite this article:
Kusumvalli S, Diwan A, Pasha S, Devale MR, Chowdhary CD, Saikia P. Clinical evaluation of biodentine: Its efficacy in the management of deep dental caries. Indian J Dent Res 2019;30:191-5

How to cite this URL:
Kusumvalli S, Diwan A, Pasha S, Devale MR, Chowdhary CD, Saikia P. Clinical evaluation of biodentine: Its efficacy in the management of deep dental caries. Indian J Dent Res [serial online] 2019 [cited 2023 Mar 27];30:191-5. Available from:

   Introduction Top

One of the most critical factors in determining the prognosis of a tooth after restorative treatment in case of deep carious lesion is preserving the pulpal vitality.[1] Vital pulp therapy in the form of pulp capping and pulpotomy has long been documented as a procedure designed to maintain the vitality of the dental pulp exposed by caries.[2] Vital pulp therapy is aimed at sealing the pulp after injury and stimulating the formation of tertiary dentin.[3]

In deep carious lesions, which are closer to the dental pulp, there occurs an increased number of macrophages, lymphocytes, and occasional polymorphonuclear leukocytes. Dilation of blood vessels becomes apparent; however, the pulp remains structurally intact.[4] The activity of a deep carious lesion in dentine can be preferentially modified, by sealing in the dentine caries. This allows reparative pulp-dentine complex reactions to take place.[5] The dental pulp, when exposed, may respond favorably to application of a variety of materials used in pulp capping procedures. Many studies have confirmed the formation of hard tissue over the site of the exposure.[6] The success rates of vital pulp therapy in permanent teeth after 3 year follow-up are 72.9%.[7]

“The deep caries lesion dilemma” – A sense of inadequacy, often bordering on frustration, frequently accompanies any attempt to predict the pathologic state of the dental pulp.[4],[8] It has been acknowledged for some time that one of the prerequisites for success in vital pulp therapy procedure is the satisfactory diagnosis of the status of the pulp at the time of the clinical procedure.[2],[9]

The quest for “interactive” or “bioactive” dental restorative materials which regenerates dentine is not a totally new endeavor. Improved knowledge at both biomaterial and cellular level has led to the introduction of “hydraulic calcium silicate” cement. Hydraulic calcium silicate cements, also known as the bioceramic materials, are bioactive materials showing a dynamic interaction with dentine and pulp tissue interface.[10] “Biodentine,” a calcium silicate-based product, is specifically designed as a “dentine replacement” material. Biodentine had the potential to significantly increase TGF-β1 secretion from pulp cells and induce an early form of reparative dentin synthesis. Based on all its properties, Biodentine has been claimed to be a bioactive dentine substitute, with perfect sealing ability, for direct pulp capping, pulpotomy, repair of root perforation, apexification, and retrograde root fillings.[11]

Hence, this study is intended to assess clinically and radiographically the success rate of Biodentine as pulp capping material in human permanent teeth with deep carious lesion.

   Methodology Top

The patients selected for this study were taken from the Department of Conservative Dentistry and Endodontics of Sri Rajiv Gandhi College of Dental Sciences, Bangalore, over a period of 1 year between 2016 and 2017. Twelve patients were treated after the diagnosis of deep dental caries which was confirmed both clinically and radiographically.

The institutional review board ethics committee gave ethical approval for the study (SRGCDS/2015/538/C). All the participants or legal guardians were asked to sign an informed consent form in which the treatment was explained briefly. Inclusion criteria were patients aged between 15 and 40 years, a positive cold test, absence of spontaneous or lingering pain, absence of pain on percussion, and absence of sinus tract or swelling. Teeth with any periapical changes or open apex were excluded from the study. A detailed clinical history was taken followed by percussion and sensibility tests. Radiographic examination was performed which included an IOPAR and a bitewing of the involved tooth.

All the procedures were performed under rubber dam (Hygienic; Coltene/Whaledent AG, Switzerland) and local anesthesia with 2% lignocaine containing epinephrine 1:100,000 (Lignox 2% ADR; Warren Pharmaceutical Pvt Ltd, Mumbai, India). Caries excavation was performed by using a 3-step procedure:

  1. High-speed caries enamel removal with a round diamond bur (Mani, Japan)
  2. Removal of carious dentin was done with a low-speed carbide bur (SS White, Lakewood, NJ)
  3. Final excavation of soft carious dentin was done using a sharp spoon excavator (Dentsply Maillefer, Switzerland).

In cases where pulpal bleeding occurred, hemostasis was achieved by pressing moist cotton pellets on the pulp wound for 1–2 min and finally disinfecting the cavity with 3% sodium hypochlorite. The surrounding dentin was gently air dried with a two-way syringe until all the excess water was removed.

Biodentine was chosen as a pulp-capping material. It was mixed as per the manufacturers' recommendation, i.e., 5 drops of liquid of the Biodentine pack is emptied in the capsule containing the powder and then it is mixed in the amalgamator at a speed of 4000–4200 rotations/min for 30 s. The mix is then carried on the exposed pulp tissue using an amalgam carrier and is then applied evenly using a plastic filling instrument. Biodentine allows a working time of 5–6 min and sets in approximately 12 min. After 12 min of application of Biodentine on the exposed pulp, the material sets. During this time, the appearance of the Biodentine surface changed from glossy to matt, and then, a final restoration of composite was done. A matrix band was adjusted, and self-etch adhesive agent (OptiBond Solo; KerrHawe Neos, Orange) was then applied with a microbrush in a brushing motion for 20 s and excess blown out. It was then light cured for 20 s. All cavities were filled with composites (Tetric evo Ceram, Ivoclar Vivadent) in increments and light cured for 40 s [Figure 1], [Figure 2], [Figure 3], [Figure 4]. Patients were recalled at 1-month, 3-month, and 6-month interval to evaluate the outcome of the treatment through pulp vitality test and radiographic evaluation.
Figure 1: Preoperative radiograph (n = 47)

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Figure 2: Caries excavation

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Figure 3: Biodentine placement

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Figure 4: Final restoration

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Success was defined as clinically no signs and symptoms, responds to sensibility tests at every follow-up, no tooth discoloration seen, and radiographically no periapical changes seen.

Data entry and analysis were performed by Fisher's exact test with a significance level of P < 0.05.

   Results Top

The sample size in this study consisted of 12 adult permanent teeth which include both occlusal and proximal deep caries. Out of the 12 teeth, direct pulp capping was carried out in 7 and the rest went for indirect pulp capping procedure. Two out of the 12 treated teeth had undergone failure, i.e., the patient returned back within a period of 3 months with the complaint of continuous pain. In the 2 failed cases, on clinical examination, there was tenderness on percussion but no swelling, abscess, or sinus opening; radiographically, there was widening of the periodontal ligament space. In one of the failed cases, bleeding had occurred on caries excavation; however, it stopped within 5 min and direct pulp capping procedure was carried out; however, in the other failed case, no bleeding was observed. The rest 10 patients were recalled at follow-up periods for 12 months. In all the follow-ups, both clinical and radiographic examinations were carried out; clinically, the teeth presented with no clinical signs and symptoms were responding positive to the sensitivity tests, and radiographically, there was no changes in the periapical region seen [Figure 5] and [Figure 6]. The overall success observed was 83.4% (10 of 12), and the failure rate was 16.7% (2 of 12) [Table 1].
Figure 5: 6-month follow-up

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Figure 6: 12-month follow-up

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Table 1: Outcome of vital pulp therapy with Biodentine

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   Discussion Top

One of the most controversial dilemmas in endodontics is management of deep carious lesion. Two schools of thought which are most debated in the management of such cases are whether to go for a conservative approach with vital pulp therapy or to consider an invasive but reliable procedure, i.e., root canal treatment. Vital pulp therapy aims to preserve and maintain pulp tissue that has been compromised but not destroyed by caries, trauma, or restorative procedures in a healthy state.[12]

This procedure should be carried out in teeth with reversible pulpitis as the main requirement of this procedure is the presence of vital pulp tissue. However, accurate determination of the status of the pulp becomes a challenging factor. The clinical signs and symptoms and the sensibility testing do not precisely determine the status of the pulp. Hence, preserving the vital pulp tissues and eliminating the diseased ones lead to an optimal treatment outcome in vital pulp therapy.[13]

Another crucial factor determining the success of vital pulp therapy is a suitable dressing material. Since ages, calcium hydroxide has been considered as the “gold standard” in the treatment of vital pulp therapy. The success rate of direct pulp capping with CH varied widely between 31.8% after 1 year[14] and 72.7% after 10 years.[15] However, the disadvantages with this material are poor bonding to dentin, material resorptions, tunnel defects, and mechanical instability because of which calcium hydroxide does not prevent microleakage in the long run. In addition, the high pH (12.5) of calcium hydroxide suspensions causes liquefaction necrosis at the surface of the pulp tissue.[16]

Biodentine™ (Septodont Ltd., Saint Maur des Faussex's, France), a new tricalcium silicate (Ca3 SiO5)-based cement, advertised as “bioactive dentine substitute,” has drawn attention in recent years and has been advocated to be used in pulp capping procedures. The results have shown that Biodentine encourages hard tissue regeneration and provoke no signs of pulp.[16]

Nowicka et al. in their study observed that when Biodentine is used as a pulp-capping material, complete dentinal bridge formation occurred with absence of inflammatory pulp response. Furthermore, well-arranged layers of odontoblast-like cells were found to form tubular dentin under the osteodentin.[17]

The case selection criteria in this study was no history of spontaneous pain, sensitivity to cold was shortlived, electric pulp test demonstrated a vital tooth, and radiographs did not show any evidence of apical lesion which indicated a vital pulp. The condition of the pulp plays a decisive role in the outcome of conservative pulp treatment; hence, the pulp should be carefully examined to decide whether the pulp is worthy of preserving. When encountering clinical pulp exposure, it has been claimed that the degree of pulpal bleeding reflects the severity of pulpal inflammation. Profuse bleeding that is difficult to stop indicates that the pulp tissue is severely inflamed.[18] Several studies considered the “time to stop bleeding” should be within 5–10 min, and this parameter acts as a cutoff point to discriminate between the reversible and irreversible condition of the pulp.[19] In this study, however, this “time to stop bleeding” parameter was found to be within this range, thereby indicating a healthy pulp.

In the cases done here, placement of a permanent restoration was done at the same appointment. This one-stage procedure helps to prevent the chance of failure as well as restores the esthetics of the tooth. However, when opting for this approach, it is important to wait for Biodentine™ to set (about 12–15 min after mixing) before proceeding with the restorative treatment. Studies have found that Biodentine performs well without any conditioning treatment as a dentine substitute.[20] Hence, etching of Biodentine is not recommended, and it is directly bonded to the resin composite. Odabaş et al. compared the shear bond strength of different adhesive systems to Biodentine and found no statistically significant difference between 1-step self-etch, 2-step self-etch adhesives, and etch–and-rinse adhesive systems.[21] In this study, a total etch adhesive system was used for bonding composite resin.

The success rate of this procedure in this study is optimum if the following conditions are met: (1) the pulp was not inflamed, (2) hemorrhage was properly controlled, (3) the nontoxic nature of Biodentine as pulp capping material, and (4) the capping material and restoration seal out all the bacteria.[12]

The success seen in this study is probably due to noncytotoxic and nongenotoxic effect on pulp tissues,[11],[22] its sealing ability due to penetration of Biodentine into pulpal tissues forming tag-like structures in dentinal tubules,[23] and adequate marginal seal at the interface of enamel, dentine, and dentine-bonding agents with adequate microhardness.[20],[24]

Information of the two failed cases did not provide any conclusion as to which factors caused the unfavorable outcomes. Failed cases presented either with painful pulpitis or apical periodontitis. One of the causes of failure may be attributed to the fact that uncontrolled deterioration of the remaining pulp must have occurred. The unfavorable outcomes also reflect flaws which might have occurred during case selection in terms of pulpal pathosis.

   Conclusion Top

Biodentine tricalcium silicate cement appears to offer a promising therapeutic intervention for preservation of pulp vitality in cases of deep caries. The ability of Biodentine to achieve biomimetic mineralization has great potential to revolutionize the management of affected teeth in the operative dentistry and endodontics.

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Conflicts of interest

There are no conflicts of interest.

   References Top

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Laurent P, Camps J, About I. Biodentine (TM) induces TGF-β1 release from human pulp cells and early dental pulp mineralization. Int Endod J 2012;45:439-48.  Back to cited text no. 11
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Bjørndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Näsman P, et al. Treatment of deep caries lesions in adults: Randomized clinical trials comparing stepwise vs. Direct complete excavation, and direct pulp capping vs. Partial pulpotomy. Eur J Oral Sci 2010;118:290-7.  Back to cited text no. 14
Horsted P, Sandergaard B, Thylstrup A, El Attar K, Fejerskov O. A retrospective study of direct pulp capping with calcium hydroxide compounds. Endod Dent Traumatol 1985;1:29-34.  Back to cited text no. 15
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Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, et al. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod 2013;39:743-7.  Back to cited text no. 17
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Correspondence Address:
Dr. S Kusumvalli
Department of Conservative Dentistry and Endodontics, Sri Rajiv Gandhi Dental College of Science and Hospital, Chola Nagar, R T Nagar Post, Bengaluru - 560 032, Karnataka
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijdr.IJDR_333_17

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  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]

  [Table 1]

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