Clinical trial NCT00587834: Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Recession
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
First posted: 2008-01-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
timeFrame: 6 months
Secondary outcomes:
measure: Color Same as Adjacent Tissues After 6 Months (Superiority)
timeFrame: 6 months
measure: Texture Same as Adjacent Tissues After 6 Months (Superiority)
timeFrame: 6 months
measure: Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
timeFrame: 6 months
measure: Patient Preference After 6 Months/Early Termination (Superiority)
timeFrame: 6 months
measure: Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)
timeFrame: 6 months
measure: Pain Absent After 3 Days (Superiority)
timeFrame: Day 3
Other outcomes:
Locations:
city: Boston
country: United States
facility: Nevins Perio, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
city: Houston
country: United States
facility: Perio Health Professionals, PLLC
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center - San Antonio
state: Texas
Study officials:
affiliation: Perio Health Professionals, PLLC
name: Michael McGuire, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.