Accession Number : AD1047985


Title :   Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa


Descriptive Note : Technical Report,30 Sep 2016,29 Sep 2017


Corporate Author : Regents of the University of Michigan Ann Arbor United States


Personal Author(s) : Feinberg, Stephen E


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/1047985.pdf


Report Date : 01 Oct 2017


Pagination or Media Count : 6


Abstract : 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 has recently been awarded a No Cost Extension to continue its recruitment efforts.


Descriptors :   SKIN GRAFTS , clinical trials , RECONSTRUCTIVE SURGICAL PROCEDURES , ORAL SURGERY


Subject Categories : Medicine and Medical Research


Distribution Statement : APPROVED FOR PUBLIC RELEASE