A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva
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
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2005
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 28, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedApril 9, 2012
April 1, 2012
8 months
February 28, 2012
April 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of attached gingiva
Change in the amount of attached gingiva
6 months
Secondary Outcomes (9)
Inflammation
week 1, week 4, month 3 and month 6
Color of grafted tissue
4 weeks, 3 months, 6 months
Texture of grafted tissue
4 weeks, 3 months, 6 months
Oral muscle pull
6 months
Probing depth
6 months
- +4 more secondary outcomes
Study Arms (2)
Split-mouth design: Treatment
EXPERIMENTALSplit-mouth design: Control
ACTIVE COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- Subject is 18 years of age or older at the time of enrollment, and not older than seventy years.
- 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).
- Root coverage is not desired or indicated at the time of grafting.
- Females of childbearing potential must have a documented negative urine or serum 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.
You may not qualify if:
- 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.
- Subjects with any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) which could compromise wound healing and preclude periodontal surgery.
- 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.
- Subjects with the presence of acute infectious lesions in the areas intended for surgery.
- Subjects who smoke.
- Teeth requiring treatment are molars.
- Teeth with axial mobility.
- Known hypersensitivity to bovine collagen.
- Subjects enrolled in medical, dental, or any investigational device study for any disease within the past four weeks.
- Subjects who have received an investigational drug or biological treatment within the three months prior to study enrollment (medical or dental).
- Subjects previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organogenesislead
Study Sites (1)
PerioHealth
Houston, Texas, 77063, United States
Related Publications (1)
McGuire MK, Scheyer ET, Nunn ME, Lavin PT. A pilot study to evaluate a tissue-engineered bilayered cell therapy as an alternative to tissue from the palate. J Periodontol. 2008 Oct;79(10):1847-56. doi: 10.1902/jop.2008.080017.
PMID: 18834238RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2012
First Posted
March 8, 2012
Study Start
September 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
April 9, 2012
Record last verified: 2012-04