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

Dental Pulp Capping Clinical Trial

— CPDB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891876
• Other study ID #: CPDB
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: November 28, 2017
• Start date: May 27, 2015
• Est. completion date: December 2, 2016

Study information

• Verified date: November 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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®.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2, 2016
• Est. primary completion date: December 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Capping

Locations

Country	Name	City	State
France	Chevalier	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success	Treatment success will be asses only if clinical AND radiographic examination are successful	3 months after the dental direct pulp capping