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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
Cabinet de Chirurgie Dentaire rue Saint Didier
Paris, France
Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière
Paris, France
Service d'Odontologie Hôpital Rothschild
Paris, France
Efficacy
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 3 month follow-up.
Time frame: 3 months
Long term efficacy and safety
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.
Time frame: 2 years
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NONE
Enrollment
53