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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
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.
PerioHealth
Houston, Texas, United States
Amount of attached gingiva
Change in the amount of attached gingiva
Time frame: 6 months
Inflammation
Change from baseline in inflammation score
Time frame: week 1, week 4, month 3 and month 6
Color of grafted tissue
Color match of the grafted tissue to the adjacent tissue
Time frame: 4 weeks, 3 months, 6 months
Texture of grafted tissue
Texture match of the grafted tissue to the adjacent tissue
Time frame: 4 weeks, 3 months, 6 months
Oral muscle pull
Resistance to oral muscle pull
Time frame: 6 months
Probing depth
Change in probing depth from baseline
Time frame: 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
Time frame: 6 months
Overall Subject Preference
VAS scale subject assessment of each treated site with anchors of "disappointed" and "fully satisfied".
Time frame: 6 months
Recession depth
Change in recession depth
Time frame: 3 months, 6 months
Keratinized tissue
Width of keratinized tissue
Time frame: 3 months, 6 months
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