Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa
Technical Report,30 Sep 2017,29 Sep 2018
Regents of the University of Michigan Ann Arbor United States
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This is a randomized, parallel-group phase II study to assess the safety and efficacy for use of human EVPOME for soft tissue intraoral grafting procedures compared to the gold standard palatal oral mucosa POM graft. The study will determine differences in the primary efficacy measure of increased keratinized mucosa secondary measures of graft contracture and Wound Healing Index and ancillary outcome measures of tissue perfusion measured graft color and laser Doppler flowmetry, and postoperative pain. Sixty subjects, thirty subjects per treatment group, will be randomized to receive either the experimental treatment, EVPOME Group 1, or standard of care, the palatal oral mucosa POM graft Group 2. The study population will include non-smoking adults ages 18 and older in need of additional keratinized oral mucosa This trial was awarded a No Cost Extension to continue its recruitment efforts thru September2018. The trial was recently awarded an additional No Cost Extension to extend the study follow-up thru the end of the year 2018.
- Medicine and Medical Research