3-months Success Rate of Direct Pulp Capping With Biodentine® (CPDB)
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|ClinicalTrials.gov Identifier: NCT02891876|
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : November 29, 2017
|Condition or disease|
|Dental Pulp Capping|
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 Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||3-months Success Rate of Direct Pulp Capping With Biodentine®|
|Actual Study Start Date :||May 27, 2015|
|Actual Primary Completion Date :||December 2, 2016|
|Actual Study Completion Date :||December 2, 2016|
- Treatment success [ Time Frame: 3 months after the dental direct pulp capping ]Treatment success will be asses only if clinical AND radiographic examination are successful
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891876
|Brest, France, 29200|