Clinical Trial of New Elastomer for Maxillofacial Prosthetics

Overview

The purpose of this study is to evaluate a new rubber material used to make prosthetic replacements of the face lost to cancer, trauma, or birth defects.

Maxillofacial prosthetics is a subspecialty of prosthodontics, providing the clinical rehabilitation treatment of patients who have lost parts of the face due to cancer, trauma, or birth defects. It is an orphan field that: * treats few patients, making the subspecialty unprofitable for manufacturers to develop new materials; * offers fundamental rehabilitation and improvement in the quality of life to patients who may have exhausted personal or third party funding; and * provides a dental solution to an essentially medical problem. Silicone rubber materials have been used for facial rehabilitation for more than 4 decades with few improvements. There is a clear need for new, alternative, and more economic materials for extraoral maxillofacial prostheses. Research at Gulf South Research Institute in New Orleans by the Principal Investigator and others in the 1970s and 1980s developed an alternative low-cost thermoplastic industrial rubber material (chlorinated polyethylene, CPE) that met all toxicological (safety) and physical (effectiveness) requirements. A Phase 2 clinical trial at the time yielded equivocal results when compared to conventional but costly silicone rubber products. This research is a controlled, randomized, single-crossover, double-blinded investigator-initiated multicenter Phase 3 clinical trial treating 100 patients that evaluates: * experimental thermoplastic CPE; and * control silicone (Silastic Adhesive A/MDX4-4210) materials for non-inferiority of CPE based on functional and subjective characteristics, and on the quality of life. The clinical centers of the trial are at M.D. Anderson Cancer Center in Houston, Texas, and at the Toronto Sunnybrook Regional Cancer Centre in Toronto, Canada.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes