A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva
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.
|Gingival Recession||Device: Gintuit Other: autologous Free Gingival Graft (FGG)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Clinical Trial to Assess the Safety and Efficacy of Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) in Establishing a Functional Zone of Attached Gingiva|
- Amount of attached gingiva [ Time Frame: 6 months ]Change in the amount of attached gingiva
- Inflammation [ Time Frame: week 1, week 4, month 3 and month 6 ]Change from baseline in inflammation score
- Color of grafted tissue [ Time Frame: 4 weeks, 3 months, 6 months ]Color match of the grafted tissue to the adjacent tissue
- Texture of grafted tissue [ Time Frame: 4 weeks, 3 months, 6 months ]Texture match of the grafted tissue to the adjacent tissue
- Oral muscle pull [ Time Frame: 6 months ]Resistance to oral muscle pull
- Probing depth [ Time Frame: 6 months ]Change in probing depth from baseline
- 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) [ Time Frame: 6 months ]Change in clinical attachment level (mm) from baseline
- Overall Subject Preference [ Time Frame: 6 months ]VAS scale subject assessment of each treated site with anchors of "disappointed" and "fully satisfied".
- Recession depth [ Time Frame: 3 months, 6 months ]Change in recession depth
- Keratinized tissue [ Time Frame: 3 months, 6 months ]Width of keratinized tissue
|Study Start Date:||September 2005|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
|Experimental: Split-mouth design: Treatment||
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.
|Active Comparator: Split-mouth design: Control||
Other: autologous Free Gingival Graft (FGG)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547962
|United States, Texas|
|Houston, Texas, United States, 77063|