Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration

Phase 3

Completed

Conditions: Gingival Recession

Interventions: Device: Gintuit
Other: Autologous palatal tissue

Registration Number: NCT00587834

Lead Sponsor: Organogenesis

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 96

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gintuit	Within-subject design: one side of the mouth receives Gintuit
2	Autologous palatal tissue	Within-subject control: one side of mouth receives tissue harvested from the palate

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.	6 months	The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.	6 months	The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.
Pain Absent After 3 Days (Superiority)	Day 3	Pain Assessment(Modified Intent-to-Treat Population)
Texture Same as Adjacent Tissues After 6 Months (Superiority)	6 months	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.
Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)	6 months	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.
Patient Preference After 6 Months/Early Termination (Superiority)	6 months	Number of patients expressing preference for Gintuit.
Color Same as Adjacent Tissues After 6 Months (Superiority)	6 months	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.

Trial Locations

Locations (4): Nevins Perio, LLC
🇺🇸
Boston, Massachusetts, United States
Perio Health Professionals, PLLC
🇺🇸
Houston, Texas, United States
Michigan Center for Oral Health Research
🇺🇸
Ann Arbor, Michigan, United States
University of Texas Health Science Center - San Antonio
🇺🇸
San Antonio, Texas, United States