OrACELL™ vs. Connective Tissue in Miller Class 3 Defects

A COMPARATIVE STUDY OF ROOT COVERAGE USING OrACELL™ VERSUS SUBEPITHELIAL CONNECTIVE TISSUE GRAFT: A RANDOMIZED CONTROLLED TRIAL

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.

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.

Inclusion Criteria:

1. Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
2. 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
3. Study is limited to vital and nonvital incisors, canines, and premolars
4. 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
5. Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
6. Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery

Exclusion Criteria:

1. Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
2. History of previous history of surgery performed at surgical sites included in study
3. Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
4. Non-English speakers
5. Pregnant or lactating females
6. Immunosuppressant medications