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

Meccellis Biotech

Status: Active, not recruiting

Conditions: Dental Surgery

Treatments: Device: CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)

Study type: Observational

Funder types: Industry

Identifiers

NCT05435976

DS_01_CIP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.