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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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
Nevins Perio, LLC
Boston, Massachusetts, United States
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States
Perio Health Professionals, PLLC
Houston, Texas, United States
University of Texas Health Science Center - San Antonio
San Antonio, Texas, United States
Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.
Time frame: 6 months
Color Same as Adjacent Tissues After 6 Months (Superiority)
An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Red", "Equally Red", or "Less Red" as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome.
Time frame: 6 months
Texture Same as Adjacent Tissues After 6 Months (Superiority)
An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Firm", "Equally Firm", or "Less Firm" as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome.
Time frame: 6 months
Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.
Time frame: 6 months
Patient Preference After 6 Months/Early Termination (Superiority)
Number of patients expressing preference for Gintuit.
Time frame: 6 months
Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)
The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.
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Time frame: 6 months
Pain Absent After 3 Days (Superiority)
Pain Assessment(Modified Intent-to-Treat Population)
Time frame: Day 3