Treatment Off Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft. (MUCODERM)

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: transplants

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • France
    • Nice, France, France, 06000
      • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transplants of acellular matrix	Procedure: transplants; Transplant of palatine tissue and transplant of connective tissue Mucoderm
Active Comparator: Transplants of connective tissue	Procedure: transplants; Transplant of palatine tissue and transplant of connective tissue Mucoderm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Root coverage	Comparison of Percentage of Root coverage at baseline and 6 months postoperatively	at 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperation pain	visual analogic scale (at control and test side),	at day 1 postoperation
postoperation pain	visual analogic scale (at control and test side),	at day 2 postoperation
postoperation pain	visual analogic scale (at control and test side),	at day 3 postoperation
postoperation pain	visual analogic scale (at control and test side),	at day 5 postoperation
postoperation pain	visual analogic scale (at control and test side),	at day 10 postoperation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2017
• Primary Completion (Actual): September 7, 2020
• Study Completion (Actual): September 7, 2020

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession; Surgical Procedures, Operative; Transplantation; Organ Transplantation
• Other Study ID Numbers: 16-PP-07

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