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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-12

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dental Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)

Biological membranes used in dental surgery

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No