An observational study in Dental Surgery, sponsored by Meccellis Biotech. Active, not recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Meccellis Biotech · Observational
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:
Meccellis Biotech is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult with an indication of keratinized soft tissue regeneration in the buccal cavity and/or keratinized soft tissue development around teeth or implants
Exclusion Criteria:
Biological membranes used in dental surgery
Rate of adverse events including reoperation following a complication and matrix removal
Percentage
Time frame: From the surgical procedure throughout the entire 24-month follow-up period
Evaluation of periodontium thickness
Photographs
Time frame: Before surgery and at the 15-day and 3-month follow-up visits
Evaluation of keratinized tissue width
Measures using a periodontal probe
Time frame: Before surgery and at the 15-day and 3-month follow-up visits
Evaluation of the periodontal biotype
Maynard and Wilson classification
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During the surgical procedure
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Meccellis Biotech