Treatment of Multiple Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft: a Randomized Controlled Clinical Study

Centre Hospitalier Universitaire de Nice1 site in 1 country12 target enrollmentJune 23, 2017

ConditionsGingival Recession

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gingival Recession
Sponsor: Centre Hospitalier Universitaire de Nice
Enrollment: 12
Locations: 1
Primary Endpoint: Percentage of Root coverage
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 23, 2017

End Date

September 7, 2020

Last Updated

last month

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nice

Responsible Party

Sponsor

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 ≥
•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.