A COMPARATIVE STUDY OF ROOT COVERAGE USING OrACELL™ VERSUS SUBEPITHELIAL CONNECTIVE TISSUE GRAFT: A RANDOMIZED CONTROLLED TRIAL
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gingival Recession
- Sponsor
- Texas A&M University
- Enrollment
- 24
- Primary Endpoint
- Gingival Recession (Root Coverage)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.
Detailed Description
Twenty-four non-smoking, healthy patients, with 2mm or greater facial gingival recession at a minimum of one site that classified as a Miller Class I, II, or III recession defect were included. Patients were randomly assigned to either control (CTG) or OrACELL™ (test) groups, which were treated with identical surgical techniques. All root coverage clinical parameters were evaluated at baseline, 3-, and 6-months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
- •The defect must be at least 2mm in length, (measured from the CEJ to the midfacial gingival margin) and classified as either Miller Class I, II or III
- •Study is limited to vital and nonvital incisors, canines, and premolars
- •If teeth adjacent to the site to be treated had recession as well, they were included in the grafting procedure but not included in measurement
- •Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
- •Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery
Exclusion Criteria
- •Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
- •History of previous history of surgery performed at surgical sites included in study
- •Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
- •Non-English speakers
- •Pregnant or lactating females
- •Immunosuppressant medications
Outcomes
Primary Outcomes
Gingival Recession (Root Coverage)
Time Frame: 6 months
The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin