Comparison Between Biodentine and Calcium Hydroxide in the Indirect Pulp Treatment on Primary Teeth (IPT)

A Split-mouth Trial Comparing Biodentine and Calcium Hydroxide in the Indirect Pulp Treatment on Primary Teeth

Objective: The study's main purpose is to evaluate and compare the clinical and radiographic outcomes of Biodentine and a light-activated calcium hydroxide based-liner (Ultra-Blend plus®) as indirect pulp treatment (IPT) liners, over the dentin-pulp complex of vital primary molars with carious lesions approaching the pulp. Study design: 80 four-to-eight year-old patients were enrolled from a Mexican University Pediatric Dentistry Clinic. A split-mouth design trial is being conducted in order to compare both IPT interventions on 160 bilateral primary teeth, without signs or symptoms of irreversibly inflamed or degenerative pulp tissue. Teeth were treated and restored with a preformed crown in a single session, and then closely followed-up for 1, 3, 6, 12, 18, and 24 months.

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: Indirect Pulp Treatment with Bioactive Dentin Substitute; Procedure: Indirect Pulp treatment with Calcium hydroxide

Detailed Description

A Split-mouth clinical trial was the design selected. Clinical Procedures: IPT procedures were carried out by three pediatric dentistry residents (E.K.C.G., R.A.V.V., and J.M.A.R.), previously trained in the clinical setting with a pilot sample of 10 similar child patients each. Study participants received local anesthesia and rubber dam isolation, which was disinfected, followed by the remove of the carious peripheral dentin with high speed tungsten-carbide bur # 3, and air-water spray. Then, the soft dentin layer was carefully removed with a sharply-edged sterilized hand excavator, based on tactile and visual standards, leaving only the hard dentin adjacent to the pulp ceiling. The cavity was thoroughly rinsed only with water and then dried with sterilized cotton pellets; no other special disinfection protocol was applied. The next step consisted in the placement of the correspondent liner over the remanent carious dentin layer, following the manufacturers' instructions, and according to the randomly assignment scheme previously described. In the case of the control group, the liner was cured undr 20 seconds of light exposure. All treated molar were restored with stainless steel preformed crowns (3M ESPE) cemented with glass ionomer (Ketac-Cem, 3M ESPE). One week later, the same procedure was repeated in the opposite tooth with the contrary IPT agent.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• At least one restorable first or second primary molar in each side of the mouth, affected by an occlusal cavitated active caries lesion in deep dentin.
• Cooperative patients.
• Participants were included in the trial after parental acceptance through a signed informed consent.

Exclusion criteria:

• Molars with mobility, spontaneous pain or fistula, and radiographic findings such as a carious lesion with no evidence of residual dentin over the pulp chamber or manifest pulp exposition.
• Normally internal root resorption or physiological root resorption less than 1/3.
• Presence of periradicular/furcal radiolucent lesions.
• Occurrence of a carious pulp exposure and bleeding during the operative procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biodentine; Biodentine (Septodont, Saint-Maur-des-Fosses, France) has been recently introduced and marketed as a bioactive dentin substitute. The Biodentine powder contains tricalcium silicate, dicalcium silicate and calcium oxide, while its liquid consists of calcium chloride and a carboxylate-based hydrosoluble polymer (water-reducing agent). After local anesthesia and rubber dam isolation, carious peripheral dentin is eliminated with a high speed tungsten-carbide bur # 3, and air-water spray. Then, the cavity's floor soft dentin layer is carefully removed with a sharply-edged sterilized hand excavator, leaving only the hard dentin adjacent to the pulp ceiling. The cavity is thoroughly rinsed only with water and dried with sterilized cotton pellets. The next step consists in the preparation of Biodentine liner (a mix of powder and liquid), following the manufacturers' instructions, and its placement over the remanent carious dentin layer.	Procedure: Indirect Pulp Treatment with Bioactive Dentin Substitute; The indirect pulp treatment (IPT), with Biodentine is a vital pulp procedure for dep cariously primary teeth without carious exposure, involving the removal of the softened, humid and infected dentin layer, leaving intact intentionally the deepest layer of the dentin-pulp complex, followed by the placement of Biodentine and a hermetic restoration to provide a seal against microleakage, without the necessity to reenter for removing the residual caries.; Other Names: Biodentine
Active Comparator: Ultra-Blend plus (Calcium hydroxide); Ultra-Blend plus® (Ultradent Products Inc., South Jordan, UT, USA). This material is a light-activated calcium hydroxide based-liner. Calcium hydroxide has demonstrated to reduce and promote immediate deactivation of the residual microorganisms after IPT. After local anesthesia and rubber dam isolation, carious peripheral dentin is eliminated with a high speed tungsten-carbide bur # 3, and air-water spray. Then, the cavity's floor soft dentin layer is carefully removed with a sharply-edged sterilized hand excavator, leaving only the hard dentin adjacent to the pulp ceiling. The cavity is thoroughly rinsed only with water and dried with sterilized cotton pellets. The next step consists in the placement of Ultra-Blend plus liner over the remanent carious dentin layer, using a dycal metallic applicator. Finally, the liner is cured through light exposure during 20 seconds .	Procedure: Indirect Pulp treatment with Calcium hydroxide; The indirect pulp treatment (IPT), with Biodentine is a vital pulp procedure for dep cariously primary teeth without carious exposure, involving the removal of the softened, humid and infected dentin layer, leaving intact intentionally the deepest layer of the dentin-pulp complex, followed by the placement of Ultra-Blend plus, and a hermetic restoration to provide a seal against microleakage, without the necessity to reenter for removing the residual caries.; Other Names: Ultra-Blend plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain. Binary variable (present/absent).	Pain is assessed through interrogatory. It is a binary variable (pain present or pain absent)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity to percussion. Binary variable (present/absent).	Treated tooth is softly hit with a dental handle mirror. Sensitivity is recorded as a binary variable (present/absent).	2 years
Abnormal tooth mobility. Binary variable (present/absent).	This variable is measured by handling the treated tooth with two fingers. It is a binary variable (present/absent).	2 years
Soft tissues inflammation. Binary variable (present/absent).	This feature is assessed through visual examination of surrounding soft gingival tissues (texture, color, size). It is a binary variable(present/absent) .	2 years
Periradicular lesions. Binary variable (present/absent).	These lesions are observed through radiographic examination. They appear as radiolucencies around the tooth's root (s). It is a binary variable (present/absent)	2 years
Sensitivity to palpation. Binary variable (present/absent).	Treated tooth is softly pressed with a finger. Sensitivity is recorded as a binary variable (present/absent).	2 years

Collaborators and Investigators

• Sponsor: José Arturo Garrocho Rangel
• Investigators: Study Chair: María S Ruiz, M. Sc., Pediatric Dentistry Postgraduate Program

Publications and helpful links

General Publications

• Al-Zayer MA, Straffon LH, Feigal RJ, Welch KB. Indirect pulp treatment of primary posterior teeth: a retrospective study. Pediatr Dent. 2003 Jan-Feb;25(1):29-36.
• Casagrande L, Bento LW, Rerin SO, Lucas Ede R, Dalpian DM, de Araujo FB. In vivo outcomes of indirect pulp treatment using a self-etching primer versus calcium hydroxide over the demineralized dentin in primary molars. J Clin Pediatr Dent. 2008 Winter;33(2):131-5. doi: 10.17796/jcpd.33.2.82r1tp71x75m5345.
• Fernandes JM, Massoni AC, Ferreira JM, Menezes VA. Use of calcium hydroxide in deep cavities of primary teeth. Quintessence Int. 2013;44(6):417-23. doi: 10.3290/j.qi.a29503.
• Kim J, Song YS, Min KS, Kim SH, Koh JT, Lee BN, Chang HS, Hwang IN, Oh WM, Hwang YC. Evaluation of reparative dentin formation of ProRoot MTA, Biodentine and BioAggregate using micro-CT and immunohistochemistry. Restor Dent Endod. 2016 Feb;41(1):29-36. doi: 10.5395/rde.2016.41.1.29. Epub 2016 Jan 4.
• Petrou MA, Alhamoui FA, Welk A, Altarabulsi MB, Alkilzy M, H Splieth C. A randomized clinical trial on the use of medical Portland cement, MTA and calcium hydroxide in indirect pulp treatment. Clin Oral Investig. 2014;18(5):1383-9. doi: 10.1007/s00784-013-1107-z. Epub 2013 Sep 17.
• Trairatvorakul C, Sastararuji T. Indirect pulp treatment vs antibiotic sterilization of deep caries in mandibular primary molars. Int J Paediatr Dent. 2014 Jan;24(1):23-31. doi: 10.1111/ipd.12022. Epub 2013 Jan 24.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 14, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Indirect Pulp Treatment; Primary Teeth; Biodentine; Calcium Hydroxide; Split-Mouth design
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: CEI-FE-003-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Yes. Only in case of future systematic reviews with meta-analysis.