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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
Sponsor:
Information provided by (Responsible Party):
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®.

Condition or disease
Dental Pulp Capping

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).

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients with a small pulp exposure (<2mm) created during carie removal on a vital tooth
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

Information from the National Library of Medicine

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


Locations
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France
Chevalier
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02891876    
Other Study ID Numbers: CPDB
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Keywords provided by University Hospital, Brest:
direct pulp capping, biodentine