Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration
Condition: Gingival Recession
MeSH terms: Gingival Recession
Intervention: Gintuit; Autologous palatal tissue
Intervention description: Application of Gintuit at Day 0 to the gingival bed; Tissue will be harvested from the subject's palate and placed on the gingival bed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate Gintuit as a safe and effective alternative to
      palatal tissue in the treatment of subjects (with recession-type defects) who have an
      insufficient zone of attached gingiva associated with at least two nonadjacent teeth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is at least 18 years of age but no more than 70 years of age.

          -  Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw
             with an insufficient zone (< or = 1mm) of attached gingiva that requires soft tissue
             grafting. (1-3 teeth may be treated. In case of adjacent teeth requiring grafting,
             only one tooth at each site will act as test or control tooth, but all teeth will get
             the same treatment).

          -  Root coverage is not desired at the time of grafting.

          -  Females of childbearing potential must have a documented negative urine 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:

          -  Subject with class III recession in the presence of a shallow vestibule or class IV
             recession.

          -  Subject with vestibule depth of less than 7mm from base of recession.

          -  Subject with any systemic conditions that could compromise wound healing and preclude
             periodontal surgery (i.e., diabetes mellitus, cancer, human immunodeficiency virus
             (HIV), bone metabolic diseases).

          -  Subject who is currently receiving or has received within two months prior to study
             entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or
             chemotherapy which could compromise wound healing and preclude periodontal surgery.

          -  Subject with the presence of acute infectious lesions in the areas intended for
             surgery.

          -  Subject who has used any tobacco product within 3 months.

          -  Subject who is taking intramuscular or intravenous bisphosphonates.

          -  Subject with only molar teeth suitable for soft tissue grafting.

          -  Subject with teeth that have Miller Grade 2 or higher mobility.

          -  Subject with known hypersensitivity to bovine collagen and/or iodine (shellfish
             allergy).

          -  Subject who has received an investigational drug or biological/bioactive treatment
             within 30 days prior to study enrollment (medical or dental).

          -  Subject who was previously treated with Gintuit, Dermagraft or any other skin graft at
             the target site(s) or immediately adjacent teeth.

          -  Subject, 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.