NCT02891876

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®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2016

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

August 30, 2016

Last Update Submit

November 28, 2017

Conditions

Dental Pulp Capping

Keywords

direct pulp capping, biodentine

Outcome Measures

Primary Outcomes (1)

  • Treatment success

    Treatment success will be asses only if clinical AND radiographic examination are successful

    3 months after the dental direct pulp capping

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

adult patients with a small pulp exposure (\<2mm) created during carie removal on a vital tooth

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chevalier

Brest, 29200, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 8, 2016

Study Start

May 27, 2015

Primary Completion

December 2, 2016

Study Completion

December 2, 2016

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

FR(1)