Dental SurgeryNCT05435976
Evaluation of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery
An observational study of Dental Surgery, run by Meccellis Biotech at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Surgery
- What is being tested?
- CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 5 sitesFrance
- Study dates
- 12 Sep 2022to 8 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Cabinet dentaire Grange Blanche
Lyon
Cabinet PISB
Saint-Brieuc
CMCT (Centre Médico-Chirurgical de Touraine)
Saint-Cyr-sur-Loire, 37540
Cabinet dentaire des chênes
Saint-Pierre-du-Mont
Cabinet dentaire Saint Priest en Jarez
Saint-Priest-en-Jarez
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Surgery
- Being tested
- CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)
- Keywords
- dental regeneration of soft tissue, biological mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)Device
Biological membranes used in dental surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events including reoperation following a complication and matrix removal
Percentage
Measured: From the surgical procedure throughout the entire 24-month follow-up period
Secondary outcomes (7)
Evaluation of periodontium thickness
Photographs
Measured: Before surgery and at the 15-day and 3-month follow-up visits
Evaluation of keratinized tissue width
Measures using a periodontal probe
Measured: Before surgery and at the 15-day and 3-month follow-up visits
Evaluation of the periodontal biotype
Maynard and Wilson classification
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start12 Sep 2022
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meccellis Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rémy CAHUZAC, Principal investigator, Cabinet dentaire des chênes, Saint Pierre du Mont, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435976
- Sponsor's protocol ID
- DS_01_CIP
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery
- ClinicalTrials.gov ID
- NCT05435976
- Acronym / sponsor ID
- DS_01_CIP
- Conditions
- Dental Surgery
- Keywords
- dental regeneration of soft tissue, biological mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meccellis BiotechIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CELLIS Dental (Porcine Acellular Dermal Matrix, PADM)Biological membranes used in dental surgery | Device | – |
Primary outcome
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
7 secondary outcomes
Evaluation of periodontium thickness
Time frame: Before surgery and at the 15-day and 3-month follow-up visits
Evaluation of keratinized tissue width
Time frame: Before surgery and at the 15-day and 3-month follow-up visits
Evaluation of the periodontal biotype
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).
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).
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).
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.
Time frame: During the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémy CAHUZAC principal investigator
Cabinet dentaire des chênes, Saint Pierre du Mont, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Surgery, run by Meccellis Biotech at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.