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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: Gintuit
* Other: autologous Free Gingival Graft (FGG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age or older at the time of enrollment, and not older than seventy years. Subject has at least two non-adjacent teeth with an insufficient zone of attached gingiva which requires soft tissue grafting. The two selected teeth must be located in contralateral quadrants. (In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but both teeth will get the same treatment). Root coverage is not desired or indicated at the time of grafting. Females of childbearing potential must have a documented negative urine or serum pregnancy test. Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form. Subjects must be able and willing to follow study procedures and instructions. Exclusion Criteria: Teeth that have an insufficient zone of attached gingiva that would be best treated using soft tissue grafts, which would attempt to cover the denuded root surface. Subjects with any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) which could compromise wound healing and preclude periodontal surgery. Subjects who are currently receiving or have received within one week prior to study entry, systemic corticosteroids (including inhaled), immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. Subjects with the presence of acute infectious lesions in the areas intended for surgery. Subjects who smoke. Teeth requiring treatment are molars. Teeth with axial mobility. Known hypersensitivity to bovine collagen. Subjects enrolled in medical, dental, or any investigational device study for any disease within the past four weeks. Subjects who have received an investigational drug or biological treatment within the three months prior to study enrollment (medical or dental). Subjects previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s). Subjects who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Split-mouth design: Treatment<br> | Device: Gintuit<br>* 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.<br>|
| Active Comparator: Split-mouth design: Control<br> | Other: autologous Free Gingival Graft (FGG)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of attached gingiva | Change in the amount of attached gingiva | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |