NCT06467630

Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures

Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Septodont · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants are any adult patients with one of the 3 following dental treatments to be done with RTR+Membrane: * post-extraction socket preservation, * alveolar ridge augmentation, * Guided Tissue Regeneration (GTR) during immediate implant placement. Since it is a real-life evidence study in current practice, patients will be followed at their surgery and their follow-ups. Below are listed visits and type of data collected. * V1 - Surgery: Demography, Medical history and concomitant treatments, Clinical/technical information (tooth extraction, surgery, membrane and grafting materials use), Clinical Exam, Photography, X-rays or Cone Beam Computed Tomography (CBCT) * V2 - Early follow-up (including suture removal, if needed): Clinical Exam, Questionnaire, Photography * V2bis - Early follow-up: Clinical Exam, Photography * V3 - Late follow-up: Clinical Exam, Photography, X-rays or CBCT, Questionnaire

Conditions

• Guided Bone Regeneration

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	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
PROCEDURE	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

Timeline

• Start date: 2024-02-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

9 sites across 1 country: France