A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2005
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.
Epistemonikos ID: 125259ac1d57477488792cd00bc0206daf9f79ef
First added on: May 10, 2024