Tooth Injury Clinical Trial
Official title:
Open Trial, Not Randomized Study Evaluating the Efficacy and the Tolerance of RD94 in Patients Needing Endodontic Care, Medical Device Class III
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)
METHODOLOGY:
This multi-centre and open-label study comprises six groups corresponding to the six
indications tested. No placebo or reference product is involved. No randomization is required
as the indication will define the patient selection.
The six indications studied are:
- Direct pulp capping following carious pulp exposure
- Direct pulp capping following dental trauma injury to healthy pulp (partial pulpotomy)
- Repairing perforated root canals and/or the pulp chamber floor
- Retrograde endodontic surgery
- Pulpotomy in primary molars
- Apexification
Study start: October 2009
Inclusion period: 1/10/2009 to 30/06/2011
Study duration: 2 years
OBJECTIVES:
The trial objective is to illustrate the clinical efficacy and tolerance of RD94 in the
indications described.
Primary objective:
The primary objective is to show that RD94 can be easily applied in the claimed indications
and to evaluate its efficacy. This can be defined after a 6 month follow-up.
Secondary objective:
The secondary objective is to evaluate the efficacy of RD94 after a two year follow-up which
is important for safety and the longevity of the product.
TRIAL POPULATION AND NUMBER OF PATIENTS:
60 patients in three French study centers, 10 per indication studied. Depending on the
indication, children (from 3 years onwards), and/or adults will be included.
DURATION OF TREATMENT:
The product is applied on D0 (Inclusion) of the study. The follow-up period includes 2 years
with six visits: Visit1 - Week 1, Visit 2 - Month 1, Visit 3 - Month 3, Visit 4 - Month 6,
Visit 5 - Year 1, Visit 6 - Year 2.
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