3-months Success Rate of Direct Pulp Capping With Biodentine®
NCT ID: NCT02891876
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2015-05-27
2016-12-02
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
40 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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Chevalier
Brest, , France
Countries
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Other Identifiers
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CPDB
Identifier Type: -
Identifier Source: org_study_id