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

A Clinical Trial to Evaluate Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) as an Alternative to Tissue From the Palate to Enhance Oral Soft Tissue Regeneration and Wound Healing

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 Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Device: Gintuit; Other: Autologous palatal tissue

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Nevins Perio, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Michigan Center for Oral Health Research
  • Texas
    • Houston, Texas, United States, 77063
      • Perio Health Professionals, PLLC
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Science Center - San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Within-subject design: one side of the mouth receives Gintuit	Device: Gintuit; Application of Gintuit at Day 0 to the gingival bed
Active Comparator: 2; Within-subject control: one side of mouth receives tissue harvested from the palate	Other: Autologous palatal tissue; Tissue will be harvested from the subject's palate and placed on the gingival bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6 months
Patient Preference After 6 Months/Early Termination (Superiority)	Number of patients expressing preference for Gintuit.	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.	6 months
Pain Absent After 3 Days (Superiority)	Pain Assessment(Modified Intent-to-Treat Population)	Day 3

Collaborators and Investigators

• Sponsor: Organogenesis
• Investigators: Principal Investigator: Michael McGuire, DDS, Perio Health Professionals, PLLC

Publications and helpful links

General Publications

• McGuire MK, Scheyer ET, Nevins ML, Neiva R, Cochran DL, Mellonig JT, Giannobile WV, Bates D. Living cellular construct for increasing the width of keratinized gingiva: results from a randomized, within-patient, controlled trial. J Periodontol. 2011 Oct;82(10):1414-23. doi: 10.1902/jop.2011.100671. Epub 2011 Mar 29.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 7, 2008

Study Record Updates

• Last Update Posted (Estimate): November 8, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 06-PER-002-CTX