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

Dental Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435976
• Other study ID #: DS_01_CIP
• Status: Recruiting
• Start date: September 12, 2022
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Meccellis Biotech
• Contact: Claire CISTERNI, PhD
• Phone: +33 (0)6 68 13 76 26
• Email: claire.cisterni[@]meccellis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Surgery

Intervention

Device:
• CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)
Biological membranes used in dental surgery

Locations

Country	Name	City	State
France	Cabinet dentaire Grange Blanche	Lyon
France	CMCT (Centre Médico-Chirurgical de Touraine)	Saint Cyr sur Loire
France	Cabinet PISB	Saint-Brieuc
France	Cabinet dentaire des chênes	Saint-Pierre-du-Mont
France	Cabinet dentaire Saint Priest en Jarez	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Meccellis Biotech

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of periodontium thickness	Photographs	Before surgery and at the 15-day and 3-month follow-up visits
Secondary	Evaluation of keratinized tissue width	Measures using a periodontal probe	Before surgery and at the 15-day and 3-month follow-up visits
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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