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ORIGINAL ARTICLE
Year : 2019  |  Volume : 37  |  Issue : 1  |  Page : 60-66
 

Comparative evaluation of biodentine, 2% chlorhexidine with RMGIC and calcium hydroxide as indirect pulp capping materials in primary molars: An in vivo study


Department of Pedodontics and Preventive Dentistry, GITAM dental College and Hospital, Visakhapatnam, Andhra Pradesh, India

Date of Web Publication25-Feb-2019

Correspondence Address:
Dr. Kondala Rao Boddeda
Department of Pedodontics and Preventive Dentistry, KIMS Dental College and Hospital, Amalapuram, Andhra Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JISPPD.JISPPD_213_17

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   Abstract 


Background: Indirect pulp therapy (IPT) is conventional treatment of deep dentinal carious lesions without risk of pulp exposure. Development of new biomaterials with biocompatibility and seal has changed the attitudes toward IPT. Aim/Objectives: This study was conducted to evaluate and compare the clinical and radiographic success of biodentine, 2% chlorhexidine gluconate with resin-modified glass ionomer cement (RMGIC), and calcium hydroxide as indirect pulp-capping materials in primary molars over an observation period of 12 months. Materials and Methods: A total of 54 primary molars within the age group of 3–9 years, which were indicated for IPT were randomized into three groups of 18 samples each; Group I: biodentine, Group II: 2% chlorhexidine gluconate followed by RMGIC, Group III: calcium hydroxide (Dycal). These cases were followed up for evaluation clinically and radiographically at 3, 6, and 12 months. The recorded data were subjected to statistical analysis using Chi-square test. Results: After 12 months, the clinical and radiographic success of biodentine group was 100% (18/18), with 2% chlorhexidine gluconate disinfecting solution followed by RMGIC was 94.4% (17/18) and calcium hydroxide (Dycal) was 94.4% (17/18), failures included one at 3 months with RMGIC and another at 12 months with calcium hydroxide group; but there was no statistically significant difference observed between them with P = 0.361 at 3 months and P = 0.371 at 12 months interval. Conclusion: Biodentine can be effectively used as indirect pulp-capping medicament in primary teeth which has similar clinical and radiographic success as 2% chlorhexidine gluconate in conjunction with RMGIC and calcium hydroxide.


Keywords: 2% chlorhexidine gluconate, biodentine, calcium hydroxide, indirect pulp treatment, resin-modified glass ionomer cement


How to cite this article:
Boddeda KR, Rani CR, V Vanga NR, Chandrabhatla SK. Comparative evaluation of biodentine, 2% chlorhexidine with RMGIC and calcium hydroxide as indirect pulp capping materials in primary molars: An in vivo study. J Indian Soc Pedod Prev Dent 2019;37:60-6

How to cite this URL:
Boddeda KR, Rani CR, V Vanga NR, Chandrabhatla SK. Comparative evaluation of biodentine, 2% chlorhexidine with RMGIC and calcium hydroxide as indirect pulp capping materials in primary molars: An in vivo study. J Indian Soc Pedod Prev Dent [serial online] 2019 [cited 2019 Jul 17];37:60-6. Available from: http://www.jisppd.com/text.asp?2019/37/1/60/252853





   Introduction Top


Although there have been many advances in the prevention of dental caries, many teeth are still lost at an early age.[1] So, preserving deciduous teeth until their natural exfoliation is absolute for normal oral function and facial growth.[2] Hence, teeth with dental caries should ideally be restored rather than extracted.

In modern endodontics conservation of tissues is of prime consideration, where vital pulp therapy (VPT) is one, which is more biologically acceptable and less technically demanding[3] which include indirect pulp treatment (IPT), direct pulp capping, and pulpotomy.[4],[5],[6]

Teeth with deep carious lesions approximating the pulp with no signs or symptoms of pulp degeneration IPT is recommended, where the deepest layer of the remaining carious dentin is covered with biocompatible materials,[4] where the few viable bacteria in the deeper dentine layers gets inactivated with dramatic reduction in the colony-forming units of bacteria.[5] Along with hard tissue formation, the ideal properties of a pulp-capping material is to maintain vitality and function of the dental pulp, aid formation of a dentin bridge, have appropriate mechanical properties, adhere to dentin, and be simple to handle clinically.[3]

Calcium hydroxide was considered as the “gold standard” material for several decades.[7] However, they reported multiple defects in the dentinal bridge, which leads to pulp irritation, internal resorption, and ultimately tooth loss.[1],[8] Hence, over the last two decades, a number of new materials have been tested.[8]

The other material which gained interest is glass ionomer cement (GIC) as pulp-capping material because of its ability to bond with the enamel and dentin, fluoride ion release, but are sensitivity to desiccation and moisture contact during early setting stages.[9],[10],[11] To overcome these resin-modified GIC (RMGIC) were introduced, which contain hydroxyl ethyl methacrylate (HEMA) or bisphenol glycidyl methacrylate (BIS-GMA).[12]

Chlorhexidine gluconate is a chemical antiseptic commonly used in oral antimicrobial therapy which has been used as both an irrigant and an intracanal medicament and also exerts an additive effect on caries prevention when combined with fluoride.[13],[14]

In the evolution of materials which are not only biocompatible but also bioinductive, the emphasis has shifted from mere preservation to reparation of the remaining pulp tissue. One such material is Biodentine (Septodont, St. Maur-des-Fosses, France), also called as smart dentin replacement,[15] which is a bioactive calcium silicate-based material, had high mechanical properties with excellent biocompatibility, as well as a bioactive behavior.[16] It shares both its indications and mode of action with calcium hydroxide but does not have its drawbacks.[15],[16]

Considering the superior properties of Biodentine and additional property of chlorhexidine gluconate, this study was undertaken to assess clinically and radiographically the comparison of Biodentine, 2% chlorhexidine gluconate with RMGIC, and calcium hydroxide as indirect pulp-capping materials in primary molars.


   Materials and Methods Top


Patient selection and consent

Ethical clearance was attained from the Ethical Committee of GITAM Dental College and Hospital, Visakhapatnam, where 44 children within the age group of 3–9 years, who attended the Department of Pedodontics and Preventive Dentistry, GITAM Dental College and Hospital, with a total of 54 teeth were selected of which 18 teeth were considered for each material group, after informed consent was obtained. The criteria for selecting the patients for the present study were similar to the one outlined by Al-Zayer et al.[17] and Falster et al.[18]

Inclusion criteria

Clinical:

  • Patients who are healthy with no underlying systemic disorder/medical condition.
  • Primary molars with deep dental caries approximating pulp.
  • No history of spontaneous pain.
  • No tenderness to palpation or percussion.


Radiographic:

  • Radiographic evidence of an intact lamina dura.
  • Dental caries close to the pulp.
  • No signs of internal or external root resorption.


Exclusion criteria

Clinical:

  • Medically compromised patients.
  • Patients who decline to participate in the study.
  • Sharp continuous pain, persisting even after with drawl of stimulus.
  • Fistula, abscess, and swelling of the soft and periodontal tissues.
  • Pathological mobility.


Radiographic:

  • Large carious lesion with radiographic pulp exposure.
  • Radiographically the diagnosis of inter radicular or periapical radiolucency.
  • Internal/external root resorption that is not related to the normal exfoliation process.


Treatment Procedure

First appointment

After evaluating the findings related to history, clinically and radiographically, the teeth which met the inclusion criteria were anesthetized[17],[19] using 2% lignocaine (lignox × 2%, 1:80,000 adrenaline). Under rubber dam isolation,[17],[20] all the carious-infected dentin was excavated, but a layer of affected dentin was left on the floor to prevent pulp exposure. The cavity was then rinsed with water and dried [Figure 1].
Figure 1: Caries excavation

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A sable sleek caries indicator (Ultradent product, USA) was placed in the cavity preparation to ascertain whether all infected dentin had been removed from the pulpal floor, and washed out with water after 15 s, then air-dried. Areas stained dark green highlighted infected dentin and were therefore removed. Areas stained light green indicated demineralization dentin and were allowed to remain in the cavity [Figure 2] and [Figure 3].
Figure 2: Caries indicator application

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Figure 3: Indicator of infected dentine

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In Group I, Biodentine, according to manufacturer instructions, liquid was dispensed into capsule-containing powder, placed in an amalgamator designated for its manipulation, triturated for 30 s, and then the amalgamated mixture was placed in the prepared cavity till the occlusal level and occlusal adjustments were performed [Figure 4].
Figure 4: Cavity filled with biodentine

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In Group II, before the placement of RMGIC liner, 2% chlorhexidine gluconate viscous solution (Consepsis V, Ultradent product) was applied using applicator tip onto the pulpal floor for 60 s. The preparation was then air-dried, RMGIC liner (Fuji II LC, GC Corporation, Tokyo, Japan) placed into the prepared cavity, and light cured for 30 s. Care was taken to ensure that this RMGIC liner covered the pulpal floor at the deepest areas of the preparation, then finally restored with composite (Filtek™ Z250 universal Restorative-3M, ESPE, St. Paul, USA) in increments [Figure 5] and [Figure 6].
Figure 5: Application of 2% chlorhexidine gluconate

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Figure 6: RMGIC

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In Group III, calcium hydroxide (Dycal, DENTSPLY) was placed on the pulpal floor then a glass ionomer liner over it and finally restored with composite (Filtek™ Z250 universal Restorative-3M, ESPE, St. Paul, USA) in increments [Figure 7].
Figure 7: Dycal

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In all the groups following restoration, a baseline radiograph was taken using radiovisiograph in a standard radiographic procedure.

Second appointment

After 3 months, the findings related to history and clinical examination are evaluated. In Group I (Biodentine), the cavity that was filled with Biodentine is reduced to a base level followed by etching (Solo Etch 37% Orthophosphoric acid) for 15 s, rinsed with water and dried, then bonding agent (3M ESPE) was applied, polymerized for 20 s with light curing unit, and finally restored with composite (Filtek™ Z250 universal Restorative-3M, ESPE, St. Paul, USA) in increments.

Follow-up

In all the three groups, the patients were recalled for follow-up visits at 3, 6, and 12 months and interpreted with respect to findings related to history, clinically, and radiographically using radiovisiography [Figure 2], [Figure 4], and [Figure 6]

Treatment was considered to be successful if the combined clinical and radiographic features were met.[17],[18] Clinical determinants of success include intact restoration, absence of spontaneous pain, absence of sensitivity to percussion and palpation, absence of abnormal tooth mobility, no abscess/sinus formation, and no abnormal reaction to hot and cold stimuli. Radiographically included were intact lamina dura, presence of normal development of permanent successor, presence of normal physiological root resorption, lack of periapical/interradicular pathology, and absence of pathological internal and external tooth resorption.

If any of the teeth that presented clinical, radiographic signs or symptoms of irreversible pulp pathologies or necrosis were considered as failure. At the end of 1 year, the teeth without any adverse clinical signs and symptoms or free of radiographic signs of pathosis were concluded to be successful. Then, the results of the study were tabulated and subjected to statistical analysis using Chi-square test which were performed using Statistical Package for Social Sciences Version 21 (IBM, Armonk, Newyork, USA).


   Results Top


Qualitative analysis was carried out based on evaluation of the history with respect to postoperative pain and swelling during the follow-up period. Clinical examination was done to check for the presence of any intraoral swelling, pus discharge, abscess/sinus tract, dislodged restoration, tooth mobility, and tenderness to percussion and palpation. Regarding radiographic evaluation, the parameters assessed were intact lamina dura, any furcation or periapical radiolucency, and presence of any internal root resorption over a period of 1 year evaluated at 3, 6, and 12 months for all the three groups.

When evaluated both clinically and radiographically at each group at time intervals of 3, 6, and 12 months [Table 1]. In Group I (Biodentine) at 3, 6, and 12 months follow-up, all of them (18/18) showed success (100%) after evaluating both clinically and radiographically.
Table 1: Descriptive statistics showing the success and failure percentage for all the three groups at three different follow up intervals both clinically and radiographically

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In Group II (2% chlorhexidine and RMGIC) out of 18 teeth, at 3-month evaluation period, 17 teeth showed clinical success (94.4%), while one tooth is failure (1/18) as one patient complains of pain and on clinical examination, it has sinus tract with increased tooth mobility and tenderness on percussion; radiographic evidence of discontinuity of lamina dura and radiolucency at furcation and periapical area, so the radiographic success was also 94.4%. So only 17 teeth were further evaluated, which showed 100% success (17/17) both clinically and radiographically, when evaluated at 6 and 12 months.

In Group III (calcium hydroxide), out of 18 teeth, all the tooth (18/18) showed success (100%) at 3 and 6 months period, when evaluated both clinically and radiographically, while at evaluation period of 12 months, one tooth had increased the tooth mobility and had positive response to tenderness to percussion and radiographically showed discontinuity of lamina dura and radiolucency at furcation and periapical area; therefore, 1 out of 18 teeth showed failure both clinically and radiographically, so only 17 teeth showed success rate, that is, 94.4%.

To evaluate the intercomparison between the three group at 3-interval follow-up and regarding clinical and radiographic success, Chi-square test was used. The Chi-square and P value obtained when statistical analysis was done was 2.04 and P = 0.361 at 3 months and at 12 month follow-up, it was 1.98 and P = 0.371, respectively, which specifies that there is no significant difference in clinical success and radiographic success among the three groups as well as at three different evaluation periods [Table 2].
Table 2: Descriptive statistics showing the Chi-square and P values for all the three groups that three different follow up intervals both clinically and radiographically

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   Discussion Top


According to Pinto et al.,[21] the principle behind the IPT is that the deposition of reparative dentine by existing odontoblasts, where infected dentin is completely removed and anything beneath this, affected dentin must be protected. The rationale is sealing viable bacteria remain in deep dentin layers.[6]

Some describe IPT as a procedure which can be performed as a one or two visit treatment,[6],[19] Maltz et al.[19] and Orhan et al.[6] reported that one-visit approach have drawn attention to the success and claimed that there is insufficient evidence to support reentry. It was also stated that, the second visit may lead to pulp exposures and further damage to the pulp and persistence of a few microorganisms might be irrelevant. Hence, in this present clinical study, one-visit IPT was the treatment of choice.

Piva et al.[22] and Harorli et al.[23] evaluated the influence of sable seek on the microleakage of adhesive materials and found it was efficient. Hence, in this study, sable seek was used to differentiate the infected and affected dentin, a syringe delivery system containing food, drug, and cosmetic (FD and C) dark green dye in a 70% propylene glycol base, with a pH of 6.5.

Many early studies of indirect pulp capping used calcium hydroxide and found significant results. Pinto et al. (2006)[21] showed a success rate of 100%, Kerkhove et al.[24] had got a success rate of 89%, and Nirschl and Avery[25] of about 94% has been reported. Its significance was so high that whatever material comes to dental market it has been compared with calcium hydroxide, so this material is chosen as the control group in this present study against which new materials are evaluated.

The other commonly used material as pulp-capping medicament is GIC.[9],[11],[20] Owing to the modifications, new types of GICs have been developed such as the RMGIC, which can bond to both enamel and dentin, thermal expansion similar to that of tooth structure, longer working time, and operator control over the setting reaction by light activation of the resin component and consequently, an earlier development of higher bond strength, reduced brittleness, increase of tensile and flexural strengths, resistance to desiccation and acid attack, and lower moisture sensitivity and solubility.[12],[20]

According to Pinto et al.,[21] some amount of viable microorganisms still remain in the inner carious-affected dentin. So to reduce these, Rosenberg et al.[2] has advocated the use of chlorhexidine gluconate to disinfect dentin, which is a bisbiguanide antiseptic and has wide range of applications in dentistry. It also has unique feature in that dentin medicated with it acquires antimicrobial substantivity.[13],[14]

A new bioactive cement, also called as smart dentin replacement and popularly known as Biodentine,[26] is introduced as a dentin substitute. Camilleri[27] inferred that Biodentine achieves biomimetic mineralization within the depths of a carious cavity. It is available in the form of powder and liquid. The powder mainly contains tricalcium and dicalcium silicate (3 CaO SiO2 and 2 CaO SiO2), the principal component of Portland cement as well as calcium carbonate (CaCO3). Zirconium dioxide (ZrO2) serves as contrast medium. The liquid consists of calcium chloride (CaCl2.2H2O) which is used as a setting accelerator and water as reducing agent in aqueous solution with an admixture of polycarboxylate (superplasticizing agent).[15],[26]

Biodentine shares both its indications and mode of action like calcium hydroxide but does not have the drawbacks of MTA.[15],[26],[28] The distinguishing properties of biodentine which made it idiosyncratic are setting period is as short as 9–12 min, biologically it is perfectly biocompatible and capable of inducing reactionary dentin by stimulating odontoblast activity[18] and reparative dentin, by induction of cell differentiation and with better handling property. It is in effect a dentin substitute that can be used as a coronal restoration material (for indirect pulp capping) but can also be placed in contact with the pulp.

The overall success rate is 94.4% at the end of 12 months using calcium hydroxide (Dycal) as indirect pulp capping material in the present study, similar results were reported by Al-Zayer et al.[17] which showed 95% success over a period of 2 weeks to 73 months and Falster et al.[18] with 100% success at 3 and 6 months period, while at 12 months, it is 95.6%.

The IPT in primary molars using 2% chlorhexidine gluconate disinfecting solution and RMGIC liner group with the overall success rate of 94.4% at the end of 12 months follow-up. Similar results of success of IPT were reported by Marchi et al.[20] with 93% success at 4-year follow-up, while Farooq et al.[10] the success rate was 96.5%, when RMGIC was used as IPT medicament. The high success rate obtained in this present study using RMGIC in conjunction with chlorhexidine gluconate may also be due to the additive effect of chlorhexidine.[14]

Madfa et al.[26] claimed that during the setting phase of Biodentine and calcium hydroxide ions are released from the cement, which results in a pH of about 12.5 and a basification of the surroundings. This high pH inhibits the growth of microorganisms and can disinfect the dentine. Nowicka et al.[29] in an clinical and histological study, observed complete dentin bridge formation without any inflammatory pulpal response, with well-organized odontoblast and odontoblast-like cells were found to form tubular dentin under the osteodentine. Arora et al.[15] reported that the tunnel defects which is one of the drawbacks of calcium hydroxide[1],[9] is overcome by Biodentine, which showed a pattern well-localized dentine bridge formation at the injury site. Hence, Biodentine might be considered as an interesting and promising pulp-capping material during VPT.[16]

Treatment failures in two teeth were observed one at 3 months evaluation period in 2% chlorhexidine gluconate and RMGIC group and other at 12 months evaluation period in calcium hydroxide group. Nirschl and Avery[25] stated that most of the times failure is not material dependent, but due to inappropriate case selection.

The clinical and radiographic outcome after 12 months evaluation period were similar to findings observed by Marchi et al.[20] where they compared calcium hydroxide and RMGIC; with 88% with calcium hydroxide and 93% with RMGIC over a period of 4 years, while Duque et al.[30] also reported similar rate of success over a period of 3 months.

Hence, IPT is an acceptable procedure for primary teeth with reversible pulp inflammation, provided that the diagnosis is based on a good history and proper clinical and radiographic examination, and the tooth has been sealed with a leakage-free restoration and the most important factor is the appropriate case selection for the success.


   Conclusion Top


Although Biodentine exhibited the highest success rate (100%). Calcium Hydroxide liner (94.4%) and also using RMGIC liner in conjunction with 2% Chlorhexidine gluconate as disinfecting solution (94.4%) no significant difference was observed between them. This study highlights the success of IPT in primary teeth and demonstrates and justify the use of conservative treatment in VPT in deep caries lesion with asymptomatic primary teeth.

However, further longitudinal studies with longer follow-up periods should be conducted to corroborate these findings. Additional histological investigations are needed to support these findings.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

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Rosenberg L, Atar M, Daronch M, Honig A, Chey M, Funny MD, et al. Observational: Prospective study of indirect pulp treatment in primary molars using resin-modified glass ionomer and 2% chlorhexidine gluconate: A 12-month follow-up. Pediatr Dent 2013;35:13-7.  Back to cited text no. 2
    
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Bona AD, Pinzetta C, Rosa V. Effect of acid etching of glass ionomer cement surface on the microleakage of sandwich restorations. J Appl Oral Sci 2007;15:230-4.  Back to cited text no. 12
    
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Delany GM, Patterson SS, Miller CH, Newton CW. The effect of chlorhexidine gluconate irrigation on the root canal flora of freshly extracted necrotic teeth. Oral Surg Oral Med Oral Pathol 1982;53:518-23.  Back to cited text no. 13
    
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Gomes BP, Souza SF, Ferraz CC, Teixeira FB, Zaia AA, Valdrighi L, et al. Effectiveness of 2% chlorhexidine gel and calcium hydroxide against Enterococcus faecalis in bovine root dentine in vitro. Int Endod J 2003;36:267-75.  Back to cited text no. 14
    
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Arora V, Nikhil V, Sharma N, Arora P. Bioactive dentin replacement. IOSR J Dent Med Sci 2013;12:51-7.  Back to cited text no. 15
    
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[PUBMED]  [Full text]  
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Duque C, Negrini Tde C, Sacono NT, Spolidorio DM, de Souza Costa CA, Hebling J, et al. Clinical and microbiological performance of resin-modified glass-ionomer liners after incomplete dentine caries removal. Clin Oral Investig 2009;13:465-71.  Back to cited text no. 30
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]
 
 
    Tables

  [Table 1], [Table 2]



 

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