Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa (NCT01834326) | Clinical Trial Compass
TerminatedPhase 2
Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa
Stopped: The funding period for the study ended. The study did not reach full enrollment.
United States18 participantsStarted 2014-04
Plain-language summary
The purpose of this study is to improve the current standard of care of repairing mouth soft tissue defects.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Clinical Increase in Zone (Width) of Keratinized Mucosa at Grafted Site