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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery

Conditions
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Dental Surgery

Intervention / Treatment
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* Device: CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)|Biological membranes used in dental surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events including reoperation following a complication and matrix removal | Percentage | From the surgical procedure throughout the entire 24-month follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of periodontium thickness | Photographs | Before surgery and at the 15-day and 3-month follow-up visits | 
| Evaluation of keratinized tissue width | Measures using a periodontal probe | Before surgery and at the 15-day and 3-month follow-up visits | 
| Evaluation of the periodontal biotype | Maynard and Wilson classification | Before surgery and 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). | Described at each visit | At the 15-day, 3-month, 12-months and 24-months follow-up visits | 
| Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain). | Described at each visit | 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). | Described at each visit | 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. | Summarized and listed | During the surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental regeneration of soft tissue, biological mesh