Gingival RecessionMUCODERMNCT03162016
Treatment Off Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft.
A study testing transplants in people with Gingival Recession, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft harvesting. We want to show if mucoderm used in tunnel technique to recover miller class I and II recessions defects could be an alternative to connective tissue graft. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- transplants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2017to 7 Sep 2020
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 45 years, postmenopausal women (ie with amenorrhea for more than a year).
- Subject with bilateral Miller class I or II recessions defects
- non smoking patients
- patients having read and understood the information note on the study and signed the informed consent form.
- patients affiliated to the social security system.
Who cannot join
- Patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever.
- Patient with metabolic bone disease (Paget's disease, osteomalacia, osteogenesis imperfecta)
- Patient with an ASA score ≥ 3.
- Patient with absolute contra-indication to dental surgery
- Patient with severe hematologic disease
- Patient with I or type II diabetes
Show all 22Show fewer
- Patients with previous or current acute illness or severe chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, neuro-psychiatric, considered by the investigator to be incompatible with the conduct of the study.
- Patients treated with retinoids, oral bisphosphonates, oral anticoagulants or anticonvulsants.
- Patient have or have had cancer of the upper aerodigestive tract treated by radiotherapy.
- Patient taking a steroidal or non-steroidal anti-inflammatory, anti-cancer or immunosuppressive chemotherapy in the last 6 months.
- Patient monitoring considered difficult by the investigator.
- Patient with poor oral hygiene incompatible with oral surgery.
- Patients with periodontal disease unstabilized
- Patient with oral dermatitis or adverse occlusion.
- Patient with an acute or chronic infection of the surgical site (osteomyelitis).
- Patient with a known allergy to collagen
- Patient with autoimmune disease
- Patient with a linguistic or mental incapacity to understand information
- Patient younger than 45 years old
- Patient trust under curatorship or judicial protection
- Patients aged over 45 premenopausal.
- Patient participating in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Multiple Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft: a Randomized Controlled Clinical Study
Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft harvesting. We want to show if mucoderm used in tunnel technique to recover miller class I and II recessions defects could be an alternative to connective tissue graft.
Read the detailed description
Connective tissue graft harvested from the palate does not always have sufficient size to cover multiple recession defects. Moreover, connective tissue graft shows significant postoperative morbidity to treat generalized multiple gingival recessions. The goal of this study is to show if Mucoderm could be considered has a substitute of connective tissue graft in the coverage of gingival recession defects.
- Conditions
- Gingival Recession
- Being tested
- transplants
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplantsProcedure or surgery
Transplant of palatine tissue and transplant of connective tissue Mucoderm
| Study group | Role | What they receive |
|---|---|---|
| Transplants of acellular matrix | Experimental | Not described Receives: Procedure: transplants |
| Transplants of connective tissue | Active comparator | Not described Receives: Procedure: transplants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Root coverage
Comparison of Percentage of Root coverage at baseline and 6 months postoperatively
Measured: at 6 month
Secondary outcomes (5)
postoperation pain
visual analogic scale (at control and test side),
Measured: at day 1 postoperation
postoperation pain
visual analogic scale (at control and test side),
Measured: at day 2 postoperation
postoperation pain
visual analogic scale (at control and test side),
Measured: at day 3 postoperation
postoperation pain
visual analogic scale (at control and test side),
Measured: at day 5 postoperation
postoperation pain
visual analogic scale (at control and test side),
Measured: at day 10 postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start23 Jun 2017
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162016
- Sponsor's protocol ID
- 16-PP-07
- Acronym
- MUCODERM
- Status last verified
- Mar 2026
- First submitted
- 15 May 2017
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vincent-Bugnas S, Laurent J, Naman E, Charbit M, Borie G. Treatment of multiple gingival recessions with xenogeneic acellular dermal matrix compared to connective tissue graft: a randomized split-mouth clinical trial. J Periodontal Implant Sci. 2021 Apr;51(2):77-87. doi: 10.5051/jpis.2002400120.
PubMed 33913631
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Multiple Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03162016
- Acronym / sponsor ID
- MUCODERM / 16-PP-07
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 22 May 2017 (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.
Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft harvesting. We want to show if mucoderm used in tunnel technique to recover miller class I and II recessions defects could be an alternative to connective tissue graft.
Detailed description
Connective tissue graft harvested from the palate does not always have sufficient size to cover multiple recession defects. Moreover, connective tissue graft shows significant postoperative morbidity to treat generalized multiple gingival recessions. The goal of this study is to show if Mucoderm could be considered has a substitute of connective tissue graft in the coverage of gingival recession defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transplants of acellular matrix | Experimental | Procedure: transplants |
| Transplants of connective tissue | Active comparator | Procedure: transplants |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients > 45 years, postmenopausal women (ie with amenorrhea for more than a year).
- Subject with bilateral Miller class I or II recessions defects
- non smoking patients
- patients having read and understood the information note on the study and signed the informed consent form.
- patients affiliated to the social security system.
Key exclusion criteria (22 listed)
- Patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever.
- Patient with metabolic bone disease (Paget's disease, osteomalacia, osteogenesis imperfecta)
- Patient with an ASA score ≥ 3.
- Patient with absolute contra-indication to dental surgery
- Patient with severe hematologic disease
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 |
|---|---|---|
| transplantsTransplant of palatine tissue and transplant of connective tissue Mucoderm | Procedure or surgery | Transplants of acellular matrix, Transplants of connective tissue |
Primary outcome
Percentage of Root coverage
Time frame: at 6 month
Comparison of Percentage of Root coverage at baseline and 6 months postoperatively
5 secondary outcomes
postoperation pain
Time frame: at day 1 postoperation
postoperation pain
Time frame: at day 2 postoperation
postoperation pain
Time frame: at day 3 postoperation
postoperation pain
Time frame: at day 5 postoperation
postoperation pain
Time frame: at day 10 postoperation
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 24 Mar 2026.
- Results publication: PubMed 33913631Vincent-Bugnas S, Laurent J, Naman E, Charbit M, Borie G. Treatment of multiple gingival recessions with xenogeneic acellular dermal matrix compared to connective tissue graft: a randomized split-mouth clinical trial. J Periodontal Implant Sci. 2021 Apr;51(2):77-87. doi: 10.5051/jpis.2002400120.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transplants in people with Gingival Recession, run by Centre Hospitalier Universitaire de Nice at 1 site 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 5 inclusion and 22 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage of Root coverage (time frame: at 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03162016, which also lists 1 linked publication.
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 24 Mar 2026.