Active — Not RecruitingNot Applicable

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

France90 participantsStarted 2024-02-09

Plain-language 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.

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-operative wound healing measured by the Early Wound-Healing Index

Timeframe: up to 6 months

Trial details

NCT IDNCT06467630

SponsorSeptodont

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-05

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