A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Organogenesis
ClinicalTrials.gov Identifier:
NCT01547962
First received: February 28, 2012
Last updated: April 6, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a free autogenous graft using donor tissue harvested from the subject's palate in the treatment of subjects who have an insufficient zone of attached gingiva associated with at least two non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment and control in the change in amount of attached gingiva over the 6 month observation period.

Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft will be placed in the other. The grafts will be evaluated clinically to determine the change in the amount of attached gingiva and on at least three subjects, a small biopsy will be taken to allow histologic evaluation and comparison of both grafts.


Condition Intervention
Gingival Recession
Device: Gintuit
Other: autologous Free Gingival Graft (FGG)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial to Assess the Safety and Efficacy of Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) in Establishing a Functional Zone of Attached Gingiva

Further study details as provided by Organogenesis:

Primary Outcome Measures:
  • Amount of attached gingiva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in the amount of attached gingiva


Secondary Outcome Measures:
  • Inflammation [ Time Frame: week 1, week 4, month 3 and month 6 ] [ Designated as safety issue: No ]
    Change from baseline in inflammation score

  • Color of grafted tissue [ Time Frame: 4 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
    Color match of the grafted tissue to the adjacent tissue

  • Texture of grafted tissue [ Time Frame: 4 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
    Texture match of the grafted tissue to the adjacent tissue

  • Oral muscle pull [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Resistance to oral muscle pull

  • Probing depth [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in probing depth from baseline

  • Clinical attachment level (ie, distance from the cemento-enamel junction (CEJ; or another definite chosen landmark) to the base of the sulcus or periodontal pocket) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in clinical attachment level (mm) from baseline

  • Overall Subject Preference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    VAS scale subject assessment of each treated site with anchors of "disappointed" and "fully satisfied".

  • Recession depth [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    Change in recession depth

  • Keratinized tissue [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    Width of keratinized tissue


Enrollment: 25
Study Start Date: September 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Split-mouth design: Treatment Device: Gintuit
Gintuit is prepared in a "S" fold and trimmed to fit the prepared wound bed, with a standardized width of 5 mm and sutured in place with a 5/0 gut suture.
Active Comparator: Split-mouth design: Control Other: autologous Free Gingival Graft (FGG)
Autologous FGG harvested from the subject's palate, the width of the FGG will be 5 mm and sutured in place with a 5/0 gut suture.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is 18 years of age or older at the time of enrollment, and not older than seventy years.
  2. Subject has at least two non-adjacent teeth with an insufficient zone of attached gingiva which requires soft tissue grafting. The two selected teeth must be located in contralateral quadrants. (In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but both teeth will get the same treatment).
  3. Root coverage is not desired or indicated at the time of grafting.
  4. Females of childbearing potential must have a documented negative urine or serum pregnancy test.
  5. Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
  6. Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

  1. Teeth that have an insufficient zone of attached gingiva that would be best treated using soft tissue grafts, which would attempt to cover the denuded root surface.
  2. Subjects with any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) which could compromise wound healing and preclude periodontal surgery.
  3. Subjects who are currently receiving or have received within one week prior to study entry, systemic corticosteroids (including inhaled), immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
  4. Subjects with the presence of acute infectious lesions in the areas intended for surgery.
  5. Subjects who smoke.
  6. Teeth requiring treatment are molars.
  7. Teeth with axial mobility.
  8. Known hypersensitivity to bovine collagen.
  9. Subjects enrolled in medical, dental, or any investigational device study for any disease within the past four weeks.
  10. Subjects who have received an investigational drug or biological treatment within the three months prior to study enrollment (medical or dental).
  11. Subjects previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s).
  12. Subjects 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547962

Locations
United States, Texas
PerioHealth
Houston, Texas, United States, 77063
Sponsors and Collaborators
Organogenesis
  More Information

Publications:
Responsible Party: Organogenesis
ClinicalTrials.gov Identifier: NCT01547962     History of Changes
Other Study ID Numbers: 05-PER-001
Study First Received: February 28, 2012
Last Updated: April 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy

ClinicalTrials.gov processed this record on August 28, 2014