Trials / Active Not Recruiting
Active Not RecruitingNCT05435976
Evaluation of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery
Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Meccellis Biotech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 will be performed and products used according to the usual practice and the device IFU. CELLIS Dental will be used in accordance with its approved labelling. The study will be conducted in France in 4 investigational centres including 50 patients scheduled for dental regeneration of soft tissue defects and development of soft tissues around teeth or implants. Each patient will participate in one assessment period including a preoperative visit followed by the surgical procedure. Patients will return for ambulatory visits on day 15 (+/- 5 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery. CELLIS Dental will be implanted following standard techniques according to indications: * Treatment of recession defects (gingival recession), * Soft tissue augmentation around teeth and implants, * Soft tissue grafting in combination with GBR/GTR, * Covering/sealing of extraction sockets.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CELLIS Dental (Porcine Acellular Dermal Matrix, PADM) | Biological membranes used in dental surgery |
Timeline
- Start date
- 2022-09-12
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2022-06-28
- Last updated
- 2025-09-29
Locations
5 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05435976. Inclusion in this directory is not an endorsement.