Treatment Off Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft.
- Conditions
- Gingival Recession
- Interventions
- Procedure: transplants
- Registration Number
- NCT03162016
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Transplants of acellular matrix transplants - Transplants of connective tissue transplants -
- Primary Outcome Measures
Name Time Method Percentage of Root coverage at 6 month Comparison of Percentage of Root coverage at baseline and 6 months postoperatively
- Secondary Outcome Measures
Name Time Method postoperation pain at day 10 postoperation visual analogic scale (at control and test side),
Trial Locations
- Locations (1)
CHU de Nice
🇫🇷Nice, France