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Completed

NCT Number: NCT02891876

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®.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chevalier

Brest, 29200, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: CPDB

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 8, 2016
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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