Gingival Recession
Conditions
Keywords
Gingival Recession, Connective Tissue Graft, OrACELL, Decellularized Dermis, Periodontics
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.
Interventions
DEVICEOrACELL
OrACELL is human dermis that undergoes the MATRACELL process. MATRACELL is a patented and validated process that renders allograft tissue acellular, without compromising the biomechanical or desired biochemical properties of an allograft bio-implant for its intended surgical application.
DEVICEConnective Tissue Graft
A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession
Sponsors
LifeNet Health
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized Controlled Trial between two treatment modalities for gingival recession with 6 month follow-up
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Recession (Root Coverage) | 6 months | The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin |
Outcome results
None listed