Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa
Stopped early · Phase 2
Conditions studied: Disorder of Oral Mucous Membrane
In brief
The purpose of this study is to improve the current standard of care of repairing mouth soft tissue defects.
Key facts
- Study ID
- NCT01834326
- Run by
- Stephen E. Feinberg
- People needed
- 18
- Starts
- 2014-04-01
- Expected to finish
- 2019-01-15
- Last updated by the study team
- 2021-09-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Michigan, Department of Oral & Maxxillofacial Surgery — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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