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
Septodont
90 participants
Feb 9, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria9
- 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
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Interventions
* 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
* 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
* 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)
View Full Details on ClinicalTrials.gov
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NCT06467630