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

Phase 2

• Conditions: Dental Caries

• Registration Number: NCT02799927
• Lead Sponsor: José Arturo Garrocho Rangel

Brief 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.

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 Timeline

• Study Start: 2014-11
• Primary Completion: 2016-04
• Study First Submitted: 2016-05-19
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-09
• Last Update Submitted: 2016-06-14
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-16
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain. Binary variable (present/absent).	2 years	Pain is assessed through interrogatory. It is a binary variable (pain present or pain absent)

Secondary Outcome Measures

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