3-months Success Rate of Direct Pulp Capping With Biodentine®

Completed

• Conditions: Dental Pulp Capping

• Registration Number: NCT02891876
• Lead Sponsor: University Hospital, Brest

Brief Summary

Biodentine® is a most recent material for direct pulp capping. The aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®.

Detailed Description

Context : When a pulpal exposure happens on a vital tooth (without irreversible inflammation), direct pulp capping can be realized by using different biomaterials : CaOH2, MTA or Biodentine®. Biodentine® is the most recent material and its success rate for direct pulp capping is poorly documented.

Objective : The main aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®. The other aims are to determine the factors which have an influence over the success or the failure of direct pulp capping.

Method : The patient's non-opposition is obtained after a loyal explanation of the study in order to collect clinical data, if a pulpal exposure (\<2mm) happens on a vital tooth during decy excavation.

The operator registers the following data: age of the patient, type of the concerned tooth, volume of coronal pulp, surface of the pulp exposure, location, area and duration of pulp bleeding. An evaluation is realized 3 months later with the same clinical evaluation and a radiographic evaluation. If the pulp vitality is normal, the final coronal filling is then realized.

A statistical analysis will be performed to determine the success rate (binomial distribution with p=0.05). The predictive factors of success or failure will be analyzed with a logistic regression (with p=0.05).

Study Timeline

• Study Start: 2015-05-27
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Primary Completion: 2016-12-02
• Study Completion: 2016-12-02
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• adult patients with a small pulp exposure (<2mm) created during decy removal on a vital tooth
• absence of spontaneous pain, of fistula, of swelling, of mobility, of periodontal enlargement, of resorption, of periapical pathosis, of furcation defect, on this tooth
• normal periodontal probing around this tooth
• cold vitality test : positive but non increased on this tooth

Exclusion Criteria

• patient with at risk of endocarditis,
• patient with allergic reactions to a product used in the protocol,
• patient with a lack of oral hygiene,
• tooth with spontaneous pain, fistula, swelling, increased mobility, periodontal enlargement, resorption, periapical pathosis, furcation defect, pulpal necrosis, pulpal irreversible inflammation, excessive dental destruction, very abundant pulp bleeding, impossible set-up of the rubber dam
• tooth with a pulp exposure >2mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success	3 months after the dental direct pulp capping	Treatment success will be asses only if clinical AND radiographic examination are successful

Trial Locations

Locations (1)

Chevalier; 🇫🇷 Brest, France