Status:
TERMINATED
Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa
Lead Sponsor:
Stephen E. Feinberg
Conditions:
Disorder of Oral Mucous Membrane
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to improve the current standard of care of repairing mouth soft tissue defects.
Detailed Description
This study will test a tissue equivalent ex vivo produced oral mucosa equivalent(EVPOME), which is a subject's own cells grown on top of a piece of AlloDerm (a commercially available freeze dried huma...
Eligibility Criteria
Inclusion
- Deficient band (\<3mm) of keratinized mucosa prior to or following dental implant placement
- Surgery to increase width of keratinized mucosa is clinically indicated or requested by the patient to facilitate oral hygiene procedures or to improve esthetics
- Patients in need of a graft of approximately 15 x 10 x 20 mm in dimension
Exclusion
- Subjects with potential medical complications such as evidence of clinically significant (as described by investigators) renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease which may complication execution of the protocol and/or interpretation of results
- Current radiation therapy or history of radiation therapy treatment to the intraoral donor biopsy site or recipient site for graft placement
- Documented history of syphilis, HIV, Hepatitis B or C virus
- Pregnant women or women planning to become pregnant or unwilling to abstain or use double barrier contraceptives during the course of the study
- Smoking or use of tobacco products within 6 months prior to screening
- History of either alcohol or drug abuse
- Subjects taking medications that can result in gingival enlargement/overgrowth (Cyclosporine, Dilantin, calcium channel blockers)
- Current use of intravenous bisphosphonate or current oral bisphosphate use or a history of bisphosphonate use for over 5 years
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01834326
Start Date
April 1 2014
End Date
January 15 2019
Last Update
September 5 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan, Department of Oral & Maxxillofacial Surgery
Ann Arbor, Michigan, United States, 48109-5018