Clinical trial NCT05435976: Evaluation of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery
Official title: Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dental Surgery
Keywords: dental regeneration of soft tissue
biological mesh
Lead sponsor: Meccellis Biotech
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult with an indication of keratinized soft tissue regeneration in the buccal cavity and/or keratinized soft tissue development around teeth or implants

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.

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.

Primary outcomes:
measure: Rate of adverse events including reoperation following a complication and matrix removal
timeFrame: From the surgical procedure throughout the entire 24-month follow-up period
Secondary outcomes:
measure: Evaluation of periodontium thickness
timeFrame: Before surgery and at the 15-day and 3-month follow-up visits
measure: Evaluation of keratinized tissue width
timeFrame: Before surgery and at the 15-day and 3-month follow-up visits
measure: Evaluation of the periodontal biotype
timeFrame: Before surgery and at the 15-day, 3-month, 12-months and 24-months follow-up visits
measure: Surgeon aesthetic evaluation using a visual analogue scale (VAS) scored from 1 to 10 (1=unsatisfactory; 10=very satisfactory).
timeFrame: At the 15-day, 3-month, 12-months and 24-months follow-up visits
measure: Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain).
timeFrame: At the 15-day, 3-month, 12-months and 24-months follow-up visits
measure: Patient satisfaction using a visual analogue scale (VAS) scored from 1 to 10 (1=unsatisfactory; 10=very satisfactory).
timeFrame: At the 15-day, 3-month, 12-months and 24-months follow-up visits
measure: 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.
timeFrame: During the surgical procedure
Other outcomes:
Locations:
city: Lyon
country: France
facility: Cabinet dentaire Grange Blanche
city: Saint Cyr sur Loire
country: France
facility: CMCT (Centre Médico-Chirurgical de Touraine)
city: Saint-Brieuc
country: France
facility: Cabinet PISB
city: Saint-Pierre-du-Mont
country: France
facility: Cabinet dentaire des chênes
city: Saint-Priest-en-Jarez
country: France
facility: Cabinet dentaire Saint Priest en Jarez
Study officials:
affiliation: Cabinet dentaire des chênes, Saint Pierre du Mont, France
name: Rémy CAHUZAC
role: PRINCIPAL_INVESTIGATOR
References: