Informations générales (source: ClinicalTrials.gov)
Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures (ObsR+)
Observational
Septodont (Voir sur ClinicalTrials)
février 2024
décembre 2025
25 juin 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hospital University of Nantes - 44000 - Nantes - France | Alain Hoornaert, DDS | Contact (sur clinicalTrials) | |||
| Private dental practice office of Dr. Alain Hoornaert - 44000 - Nantes - France | Alain Hoornaert, DDS | Contact (sur clinicalTrials) | |||
| Private dental practice office of Dr. Aurélien Fruchet - 85340 - Olonne-sur-Mer - France | Aurélien Fruchet, DDS | Contact (sur clinicalTrials) | |||
| Private dental practice office of Dr. Edouard Lanoiselée - 44170 - Nozay - France | Edouard Lanoiselée, DDS | Contact (sur clinicalTrials) | |||
| Private dental practice office of Dr. Hélène Le Hécho - 49530 - Orée d'Anjou - France | Hélène Le Hécho, DDS | Contact (sur clinicalTrials) | |||
| Private dental practice office of Dr. Nicolas Strube - 44700 - Orvault - France | Nicolas Strube, DDS | Contact (sur clinicalTrials) | |||
| Private dental practice office of Dr. Romain Besnier - 44700 - Orvault - France | Romain Besnier, DDS | Contact (sur clinicalTrials) | |||
| Private dental practice office of Dr. Samer Saloum-Rouxel - 44000 - Nantes - France | Samer Saloum-Rouxel, DDS | Contact (sur clinicalTrials) | |||
| Private dental practice office of Dr. Xavier Struillou - 44000 - Nantes - France | Xavier Struillou, DDS | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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