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

NCT05435976 | Active Not Recruiting

• 1 other identifier: DS_01_CIP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Dental Surgery

Keywords

dental regeneration of soft tissue; biological mesh

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Evaluation of periodontium thickness

  Before surgery and at the 15-day and 3-month follow-up visits

• Evaluation of keratinized tissue width

  Before surgery and at the 15-day and 3-month 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

• 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

• 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

Interventions

CELLIS Dental (Porcine Acellular Dermal Matrix, PADM) DEVICE

Biological membranes used in dental surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meccellis Biotech: lead

Study Sites (5)

Cabinet dentaire Grange Blanche

Lyon, France

Location

Cabinet PISB

Saint-Brieuc, France

Location

CMCT (Centre Médico-Chirurgical de Touraine)

Saint-Cyr-sur-Loire, 37540, France

Location

Cabinet dentaire des chênes

Saint-Pierre-du-Mont, France

Location

Cabinet dentaire Saint Priest en Jarez

Saint-Priest-en-Jarez, France

Location

Study Officials

• Rémy CAHUZAC

  Cabinet dentaire des chênes, Saint Pierre du Mont, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 28, 2022
• Study Start: September 12, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)