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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELLIS Dental (Porcine Acellular Dermal Matrix, PADM) | Device | Biological membranes used in dental surgery |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult with an indication of keratinized soft tissue regeneration in the buccal cavity and/or keratinized soft tissue development around teeth or implants
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| Name | Affiliation | Role |
|---|---|---|
| Rémy CAHUZAC | Cabinet dentaire des chênes, Saint Pierre du Mont, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet dentaire Grange Blanche | Lyon | France | ||||
| Cabinet PISB |
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| 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 |
| Saint-Brieuc |
| France |
| CMCT (Centre Médico-Chirurgical de Touraine) | Saint-Cyr-sur-Loire | 37540 | France |
| Cabinet dentaire des chênes | Saint-Pierre-du-Mont | France |
| Cabinet dentaire Saint Priest en Jarez | Saint-Priest-en-Jarez | France |