Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dental Surgery
- Sponsor
- Meccellis Biotech
- Enrollment
- 50
- Locations
- 5
- Primary Endpoint
- Rate of adverse events including reoperation following a complication and matrix removal
- Status
- Active, Not Recruiting
- Last Updated
- 7 months ago
Overview
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 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Rate of adverse events including reoperation following a complication and matrix removal
Time Frame: From the surgical procedure throughout the entire 24-month follow-up period
Percentage
Secondary Outcomes
- Evaluation of keratinized tissue width(Before surgery and at the 15-day and 3-month follow-up visits)
- Evaluation of periodontium thickness(Before surgery and at the 15-day and 3-month follow-up visits)
- Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain).(At the 15-day, 3-month, 12-months and 24-months follow-up visits)
- Evaluation of the periodontal biotype(Before surgery and at the 15-day, 3-month, 12-months and 24-months follow-up visits)
- Patient satisfaction using a visual analogue scale (VAS) scored from 1 to 10 (1=unsatisfactory; 10=very satisfactory).(At the 15-day, 3-month, 12-months and 24-months follow-up visits)
- Surgeon aesthetic evaluation using a visual analogue scale (VAS) scored from 1 to 10 (1=unsatisfactory; 10=very satisfactory).(At the 15-day, 3-month, 12-months and 24-months follow-up visits)
- Device malfunctions-deficiencies: inadequacy of a medical device with respects to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.(During the surgical procedure)