Gingival Recession Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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