Active — Not RecruitingNot Applicable

Evaluation of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery

France50 participantsStarted 2022-09-12

Plain-language summary

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Dental membrane used in dental surgery and to identify emerging risks in comparison to clinical data related to other treatment modalities. The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 50 patients followed for 24 months. The study will be conducted in France in 4 investigational centres.

Who can participate

Age range

18 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: * Patient aged ≥18 years, * Patient with an indication of keratinized soft tissue regeneration in the buccal cavity and/or keratinized soft tissue development around teeth or implants, * Patient being informed of his participation to the study and of the follow-up visits, and having given his written informed consent, * Patient being informed of the porcine origin of the device in advance of the procedure. Exclusion Criteria: * Patient with known hypersensitivity to porcine materials, * Patient with acute or chronic infection or inflammation of the buccal cavity, * Patient with a general illness contra-indicated for implantology, periodontology, stomatology, cranio-maxillo-facial surgery, * Patient who is pregnant, * Patient who is incapacitated including protected and deprived of liberty person, * Patient having refused to participate in the study, * Patient refusing to return for the follow-up visits.

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

Rate of adverse events including reoperation following a complication and matrix removal

Timeframe: From the surgical procedure throughout the entire 24-month follow-up period

Trial details

NCT IDNCT05435976

SponsorMeccellis Biotech

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Dental Surgery trials