Dental Pulp Capping Clinical Trial
Official title:
3-months Success Rate of Direct Pulp Capping With Biodentine®
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®.
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).
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