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

Dental Caries Clinical Trial

— IPT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02799927
• Other study ID #: CEI-FE-003-014
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: May 19, 2016
• Last updated: June 14, 2016
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: June 2016
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
José Arturo Garrocho Rangel

References & Publications (6)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain. Binary variable (present/absent).	Pain is assessed through interrogatory. It is a binary variable (pain present or pain absent)	2 years	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes