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NCT Number: NCT05435976

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dental Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet dentaire Grange Blanche, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)

Device

Biological membranes used in dental surgery

Primary outcomes

  1. Rate of adverse events including reoperation following a complication and matrix removal

    Time frame: From the surgical procedure throughout the entire 24-month follow-up period

    Percentage

Secondary outcomes

  1. Evaluation of periodontium thickness

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

    Photographs

  2. Evaluation of keratinized tissue width

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

    Measures using a periodontal probe

  3. Evaluation of the periodontal biotype

    Time frame: Before surgery and at the 15-day, 3-month, 12-months and 24-months follow-up visits

    Maynard and Wilson classification

  4. Surgeon aesthetic evaluation using a visual analogue scale (VAS) scored from 1 to 10 (1=unsatisfactory; 10=very satisfactory).

    Time frame: At the 15-day, 3-month, 12-months and 24-months follow-up visits

    Described at each visit

  5. Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain).

    Time frame: At the 15-day, 3-month, 12-months and 24-months follow-up visits

    Described at each visit

  6. Patient satisfaction using a visual analogue scale (VAS) scored from 1 to 10 (1=unsatisfactory; 10=very satisfactory).

    Time frame: At the 15-day, 3-month, 12-months and 24-months follow-up visits

    Described at each visit

  7. 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.

    Time frame: During the surgical procedure

    Summarized and listed

Sponsors and collaborators

Lead sponsor

Meccellis Biotech

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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