Status:
ACTIVE_NOT_RECRUITING
Evaluation of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery
Lead Sponsor:
Meccellis Biotech
Conditions:
Dental Surgery
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
The study will be prospective, multicentric, single-arm observational (non-interventional) to evaluate the safety and performance of the CELLIS Dental membrane used in dental surgery. All evaluations...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05435976
Start Date
September 12 2022
End Date
December 31 2026
Last Update
September 29 2025
Active Locations (5)
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1
Cabinet dentaire Grange Blanche
Lyon, France
2
Cabinet PISB
Saint-Brieuc, France
3
CMCT (Centre Médico-Chirurgical de Touraine)
Saint-Cyr-sur-Loire, France, 37540
4
Cabinet dentaire des chênes
Saint-Pierre-du-Mont, France