Tooth Injury
Conditions
Brief 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)
Detailed description
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.
Interventions
DEVICEApplication of Biodentine™ (RD94), dentin substitute
Sponsors
AscoPharm is conducting the study under the responsibility of SEPTODONT
Ascopharm Groupe Novasco
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* provide signed, informed consent. * be affiliated to social security. criteria for the corresponding indication: Direct pulp capping following carious pulp exposure - children (6 to 18 years) + adults * Symptomatic or asymptomatic mature or immature tooth that presented pulp exposure when scraping out carious lesions or performing cavity preparation. Direct pulp capping following dental trauma injury to healthy pulp, reformulated as a partial pulpotomy - children (6 to 18 years) + adults \- Permanent mature or immature single-root tooth having suffered traumatic injury \< 72 hours, with amelodentinal coronal fracture causing pulp exposure. Repairing perforated root canals and/or the pulp chamber floor - adults * Iatrogenic perforation of the pulpal floor, with or without LEO. * Iatrogenic perforated root canals following post space preparation involving dentin matrix, with or without LEO. * Iatrogenic perforated root canals with stripping not involving dentin matrix, with or without LEO. Retrograde endodontic surgery - adults * Failure of endodontic treatment or retreatment, evidenced by recent or persistent clinical or radiological signs of LEO and/or symptoms on a tooth in which the root canal filling looks to be of sufficiently good quality, provided that a working coronal restoration is in place. * Failure of endodontic treatment evidenced by recent or persistent clinical or radiological signs of LEO and/or symptoms on a tooth in which the root canal filling is inadequate, when orthograde retreatment does not offer a more favorable risk-benefit ratio than the surgery option. Pulpotomy in primary molars - children ( 3 to 12 years ) * Molar presenting deep carious lesion without irreversible pulpal disease, as the molar has to stay on the dental arch for at least 3 years. * Pulp exposure during excision of a carious lesion on a temporary molar that does not present irreversible pulp disease. The molar has to stay of the dental arch for at least 3 years. Apexification - children (7 to 18 years) + adults * Permanent immature single-root tooth having suffered periodontal or dentoalveolar injury causing pulp necrosis with or without periapical disease (LEO) in children, teenagers or adult patients. * Permanent immature single-root tooth presenting pulp necrosis with or without periapical disease (LEO) in children. * Apical Root Resorption
Exclusion criteria
1. History of malignancy in the last 5 years. 2. Systemic disease not stabilized within 1 month before the Inclusion Visit or judged by the investigator to be incompatible with the study or condition incompatible with the frequent assessments needed by the study. 3 Risk A cardiopathies 4. Known hypersensitivity to one of the components of the study or procedural medications. 5\. Presence or history of severe systemic allergy. 6. Presence or history of drug addiction or alcohol abuse. 7. Patient who has participated in a clinical trial with a new active substance during the month before study entry. 8\. Participation in another clinical study at the same time as the present study. 9\. Known pregnancy or lactation at study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long term efficacy and safety | 2 years | 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. |
Countries
France
Outcome results
None listed