Clinical trial NCT03162016: Treatment Off Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft.
Official title: Treatment of Multiple Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft: a Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Root coverage
timeFrame: at 6 month
Secondary outcomes:
measure: postoperation pain
timeFrame: at day 1 postoperation
measure: postoperation pain
timeFrame: at day 2 postoperation
measure: postoperation pain
timeFrame: at day 3 postoperation
measure: postoperation pain
timeFrame: at day 5 postoperation
measure: postoperation pain
timeFrame: at day 10 postoperation
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
citation: 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.