Accession Number:

AD1039056

Title:

Clinical Trial of Intraoral Grafting of Human Tissue-Engineered Oral Mucosa, Phase 2

Descriptive Note:

Technical Report,30 Sep 2013,29 Sep 2014

Corporate Author:

Regents of the University of Michigan Ann Arbor United States

Personal Author(s):

• Feinberg,Stephen E.

Report Date:

2014-10-01

Pagination or Media Count:

6.0

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 for dental rehabilitation with dental implants. This trial has started recruitment.

Descriptors:

• combat injuries
• GRAFTS
• RECONSTRUCTIVE SURGICAL PROCEDURES
• Clinical trials

Subject Categories:

• Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE