Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration
NCT ID: NCT00587834
Last Updated: 2012-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
96 participants
INTERVENTIONAL
2007-10-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Within-subject design: one side of the mouth receives Gintuit
Gintuit
Application of Gintuit at Day 0 to the gingival bed
2
Within-subject control: one side of mouth receives tissue harvested from the palate
Autologous palatal tissue
Tissue will be harvested from the subject's palate and placed on the gingival bed
Interventions
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Gintuit
Application of Gintuit at Day 0 to the gingival bed
Autologous palatal tissue
Tissue will be harvested from the subject's palate and placed on the gingival bed
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Organogenesis
INDUSTRY
Responsible Party
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Principal Investigators
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Michael McGuire, DDS
Role: PRINCIPAL_INVESTIGATOR
Perio Health Professionals, PLLC
Locations
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Nevins Perio, LLC
Boston, Massachusetts, United States
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States
Perio Health Professionals, PLLC
Houston, Texas, United States
University of Texas Health Science Center - San Antonio
San Antonio, Texas, United States
Countries
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References
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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.
Other Identifiers
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06-PER-002-CTX
Identifier Type: -
Identifier Source: org_study_id