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

Safety and Clinical Performance 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.

Study Overview

• Status: Recruiting
• Conditions: Dental Surgery
• Intervention / Treatment: Device: CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Guillaume HOFMANSKI; Phone Number: +33 (0)7 6131 11 33; Email: guillaume.hofmanski@meccellis.com
• Study Contact Backup: Name: Claire CISTERNI, PhD; Phone Number: +33 (0)6 68 13 76 26; Email: claire.cisterni@meccellis.com

Study Locations

• France
  • Lyon, France
    • Not yet recruiting
    • Cabinet dentaire Grange Blanche
    • Contact: Maud GRAMMATICA
    • Principal Investigator: Maud GRAMMATICA
  • Saint Cyr sur Loire, France, 37540
    • Not yet recruiting
    • CMCT (Centre Médico-Chirurgical de Touraine)
    • Principal Investigator: Florent SURY, MD
  • Saint-Brieuc, France
    • Not yet recruiting
    • Cabinet PISB
    • Contact: Antoine TREMELOT
    • Principal Investigator: Antoine TREMELOT
  • Saint-Pierre-du-Mont, France
    • Recruiting
    • Cabinet dentaire des chênes
    • Contact: Rémy CAHUZAC
    • Principal Investigator: Rémy CAHUZAC
  • Saint-Priest-en-Jarez, France
    • Recruiting
    • Cabinet dentaire Saint Priest en Jarez
    • Contact: Raphaëlle CONTENCIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of periodontium thickness	Photographs	Before surgery and at the 15-day and 3-month follow-up visits
Evaluation of keratinized tissue width	Measures using a periodontal probe	Before surgery and at the 15-day and 3-month follow-up visits
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Meccellis Biotech
• Investigators: Principal Investigator: Rémy CAHUZAC, Cabinet dentaire des chênes, Saint Pierre du Mont, France

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: biological mesh; dental regeneration of soft tissue
• Other Study ID Numbers: DS_01_CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No