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Efficacy and the Safety Study of RD94 in Patients With Endodontic Care

NCT01737229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2013-07-24

No results posted yet for this study

Summary

TRIAL TITLE Open trial, not randomized study evaluating the efficacy and the tolerance of RD94 in patients needing endodontic care, medical device class III.

SPONSOR:

SEPTODONT, 58 rue de Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91

Reference protocol: 09/001

PRODUCT NAME: Biodentine™ (RD94)

MEDICAL DEVICE:

Class: Bioactive dental substitute (Tricalcium silicate) Dose: not applicable Application : one single time

DEVELOPMENTAL PHASE: not applicable (medical device class III)

Conditions

  • Tooth Injury

Interventions

DEVICE

Application of Biodentine™ (RD94), dentin substitute

Sponsors & Collaborators

  • AscoPharm is conducting the study under the responsibility of SEPTODONT

    collaborator UNKNOWN

  • Ascopharm Groupe Novasco

    lead OTHER

Principal Investigators

  • Frédéric RILLIARD, Pr · Université Paris 7-Denis Diderot

  • Chantal Naulin-Ifi, Docteur · Service d'Odontologie du GHPS

  • Pierre Colon, Pr · Université Paris VII Garancière.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01737229 on ClinicalTrials.gov