OrACELL™ vs. Connective Tissue in Miller Class 3 Defects

Texas A&M University

Status: Completed

Conditions: Gingival Recession

Treatments: Device: OrACELL; Device: Connective Tissue Graft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03226600

2014-0833-BCD-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Connective Tissue Graft

Active Comparator group

Description:

Connective Tissue is harvested from the palate of the subject then placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the connective tissue graft and the recession.

Treatment:

Device: Connective Tissue Graft

OrACELL

Experimental group

Description:

Allograft Tissue (human dermis) is removed from packing and placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the OrACELL graft and the recession.

Treatment:

Device: OrACELL