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

Dental Caries Clinical Trial

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

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02799927
Study type Interventional
Source Universidad Autonoma de San Luis Potosí
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date November 2014
Completion date November 2016
View Details
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