Evaluating a synthetic membrane for dental surgery
Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
Septodont · NCT06467630
This study is testing a new synthetic dental membrane to see if it helps people heal better after different dental surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Septodont (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Nantes and 8 other locations) |
| Trial ID | NCT06467630 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance and safety of RTR+Membrane, a synthetic dental membrane, in guided tissue regeneration during various dental surgical procedures. Participants will undergo one of three treatments: post-extraction socket preservation, alveolar ridge augmentation, or Guided Tissue Regeneration (GTR) during immediate implant placement. The study will follow patients through clinical examinations, radiological imaging, and photography to evaluate post-operative wound healing over several months.
Who should consider this trial
Good fit: Ideal candidates are adult patients requiring specific dental treatments such as socket preservation, ridge augmentation, or GTR.
Not a fit: Patients with active infections, certain chronic conditions, or those undergoing simultaneous dental treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve healing outcomes and success rates in dental surgeries involving guided tissue regeneration.
How similar studies have performed: Other studies have shown promising results with similar synthetic membranes in dental procedures, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female adult patient * Patient with one of the 3 following dental treatments to be done with the study device: post-extraction socket preservation, alveolar ridge augmentation, or Guided Tissue Regeneration (GTR) during immediate implant placement. * Patient affiliated or beneficiary of a social security system. * Patient has signed his/her informed consent form. Exclusion Criteria: * Pregnancy or lactation * Active tissue infection at the implant site * Several dental treatments done simultaneously in non-contiguous dental zones * Heavy smoker (\>10 cigarettes / day) * Patient receiving long-term corticosteroid therapy, anti-rejection drugs, bisphosphonates, head \& neck radiotherapy or chemotherapy * Patient with chronic infections (such as osteomyelitis) at the surgical site * Patient with poorly controlled metabolic disorders (such as diabetes, osteomalacia, thyroid disorders) * Patient with an auto-immune disease * Patient under tutelage, vulnerable person, person without liberty, or unable to complete questionnaire independently
Where this trial is running
Nantes and 8 other locations
- Hospital University of Nantes — Nantes, France (RECRUITING)
- Private dental practice office of Dr. Alain Hoornaert — Nantes, France (RECRUITING)
- Private dental practice office of Dr. Samer Saloum-Rouxel — Nantes, France (NOT_YET_RECRUITING)
- Private dental practice office of Dr. Xavier Struillou — Nantes, France (NOT_YET_RECRUITING)
- Private dental practice office of Dr. Edouard Lanoiselée — Nozay, France (NOT_YET_RECRUITING)
- Private dental practice office of Dr. Aurélien Fruchet — Olonne-sur-Mer, France (NOT_YET_RECRUITING)
- Private dental practice office of Dr. Nicolas Strube — Orvault, France (NOT_YET_RECRUITING)
- Private dental practice office of Dr. Romain Besnier — Orvault, France (NOT_YET_RECRUITING)
- Private dental practice office of Dr. Hélène Le Hécho — Orée d'Anjou, France (RECRUITING)
Study contacts
- Principal investigator: Alain Hoornaert, DDS — University Hospital of Nantes
- Study coordinator: CCP from the Sponsor
- Email: clinical-operations@septodont.com
- Phone: +33 1 49 76 70 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Guided Bone Regeneration, Dental surgical procedures