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The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a free autogenous graft using donor tissue harvested from the subject's palate in the treatment of subjects who have an insufficient zone of attached gingiva associated with at least two non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment and control in the change in amount of attached gingiva over the 6 month observation period.
Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft will be placed in the other. The grafts will be evaluated clinically to determine the change in the amount of attached gingiva and on at least three subjects, a small biopsy will be taken to allow histologic evaluation and comparison of both grafts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split-mouth design: Treatment | Experimental |
| |
| Split-mouth design: Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gintuit | Device | Gintuit is prepared in a "S" fold and trimmed to fit the prepared wound bed, with a standardized width of 5 mm and sutured in place with a 5/0 gut suture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of attached gingiva | Change in the amount of attached gingiva | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation | Change from baseline in inflammation score | week 1, week 4, month 3 and month 6 |
| Color of grafted tissue | Color match of the grafted tissue to the adjacent tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PerioHealth | Houston | Texas | 77063 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18834238 | Result | McGuire MK, Scheyer ET, Nunn ME, Lavin PT. A pilot study to evaluate a tissue-engineered bilayered cell therapy as an alternative to tissue from the palate. J Periodontol. 2008 Oct;79(10):1847-56. doi: 10.1902/jop.2008.080017. |
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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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| autologous Free Gingival Graft (FGG) | Other | Autologous FGG harvested from the subject's palate, the width of the FGG will be 5 mm and sutured in place with a 5/0 gut suture. |
|
| 4 weeks, 3 months, 6 months |
| Texture of grafted tissue | Texture match of the grafted tissue to the adjacent tissue | 4 weeks, 3 months, 6 months |
| Oral muscle pull | Resistance to oral muscle pull | 6 months |
| Probing depth | Change in probing depth from baseline | 6 months |
| Clinical attachment level (ie, distance from the cemento-enamel junction (CEJ; or another definite chosen landmark) to the base of the sulcus or periodontal pocket) | Change in clinical attachment level (mm) from baseline | 6 months |
| Overall Subject Preference | VAS scale subject assessment of each treated site with anchors of "disappointed" and "fully satisfied". | 6 months |
| Recession depth | Change in recession depth | 3 months, 6 months |
| Keratinized tissue | Width of keratinized tissue | 3 months, 6 months |
| D055093 |
| Periodontal Atrophy |