Status:
RECRUITING
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
Lead Sponsor:
Septodont
Conditions:
Guided Bone Regeneration
Eligibility:
All Genders
18-89 years
Brief 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 impl...
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 R...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06467630
Start Date
February 9 2024
End Date
December 1 2025
Last Update
June 21 2024
Active Locations (9)
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1
Hospital University of Nantes
Nantes, France, 44000
2
Private dental practice office of Dr. Alain Hoornaert
Nantes, France, 44000
3
Private dental practice office of Dr. Samer Saloum-Rouxel
Nantes, France, 44000
4
Private dental practice office of Dr. Xavier Struillou
Nantes, France, 44000