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| Name | Class |
|---|---|
| LifeNet Health | INDUSTRY |
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The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELLâ„¢) 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 OrACELLâ„¢ (test) groups, which were treated with identical surgical techniques. All root coverage clinical parameters were evaluated at baseline, 3-, and 6-months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connective Tissue Graft | Active Comparator | 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. |
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| OrACELL | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OrACELL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Recession (Root Coverage) | The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Randomized Controlled Trial between two treatment modalities for gingival recession with 6 month follow-up
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| Connective Tissue Graft | Device | A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession |
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| D055093 |
| Periodontal Atrophy |