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Completed

NCT Number: NCT00587834

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

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nevins Perio, LLC, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gintuit

Device

Application of Gintuit at Day 0 to the gingival bed

Autologous palatal tissue

Other

Tissue will be harvested from the subject's palate and placed on the gingival bed

Primary outcomes

  1. Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.

    Time frame: 6 months

    The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.

Secondary outcomes

  1. Color Same as Adjacent Tissues After 6 Months (Superiority)

    Time frame: 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.

  2. Texture Same as Adjacent Tissues After 6 Months (Superiority)

    Time frame: 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.

  3. Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.

    Time frame: 6 months

    The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.

  4. Patient Preference After 6 Months/Early Termination (Superiority)

    Time frame: 6 months

    Number of patients expressing preference for Gintuit.

  5. Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)

    Time frame: 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.

  6. Pain Absent After 3 Days (Superiority)

    Time frame: Day 3

    Pain Assessment(Modified Intent-to-Treat Population)

Sponsors and collaborators

Lead sponsor

Organogenesis

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 7, 2008
Registry last updated
Nov 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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