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

Study Overview
=================
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).

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

Conditions
-----------------
Dental Pulp Capping

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | Treatment success will be asses only if clinical AND radiographic examination are successful | 3 months after the dental direct pulp capping | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
direct pulp capping, biodentine