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Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
Sponsor: Septodont
Summary
The goal of this observational study is to measure in real practice the performance and safety of RTR+Membrane, a synthetic dental membrane for guided tissue regeneration in periodontal or dental implant surgery. The main question it aims to answer is to measure the post-operative wound healing several months after surgery. Participants will be followed after their dental surgery via clinical examination and radiological and photos images.
Official title: Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
OBSERVATIONAL
Enrollment
90
Start Date
2024-02-09
Completion Date
2025-12
Last Updated
2024-06-21
Healthy Volunteers
No
Conditions
Interventions
Preserving alveolar bone volume after tooth extraction
* Visit 1: A periodontal or dental implant surgery is done aiming to preserve alveolar bone volume after extraction * Visit 2 (10 days ± 4 days) - Early post-surgery follow-up * V2bis (1 month +/- 1 week) - Early post-surgery follow-up * Visit 3 (5 months ± 1 month) - Late post-surgery follow-up
Alveolar crest reconstruction
* Visit 1: A periodontal or dental implant surgery is done aiming to alveolar crest reconstruction * Visit 2 (10 days ± 4 days) - Early post-surgery follow-up * Visit 3 (5 months ± 1 month) - Late post-surgery follow-up
Covering bone defects during immediate implant placement.
* Visit 1: A periodontal or dental implant surgery is done aiming to cover bone defects during immediate implant placement. * Visit 2 (10 days ± 4 days) - Early post-surgery follow-up * Visit 3 (3 months ± 1 month) - Late post-surgery follow-up
Locations (9)
Hospital University of Nantes
Nantes, France
Private dental practice office of Dr. Alain Hoornaert
Nantes, France
Private dental practice office of Dr. Samer Saloum-Rouxel
Nantes, France
Private dental practice office of Dr. Xavier Struillou
Nantes, France
Private dental practice office of Dr. Edouard Lanoiselée
Nozay, France
Private dental practice office of Dr. Aurélien Fruchet
Olonne-sur-Mer, France
Private dental practice office of Dr. Hélène Le Hécho
Orée d'Anjou, France
Private dental practice office of Dr. Nicolas Strube
Orvault, France
Private dental practice office of Dr. Romain Besnier
Orvault, France