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

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Gingival Recession

Treatments

Procedure: transplants

Study type

Interventional

Funder types

Other

Identifiers

NCT03162016

16-PP-07

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.