Clinical Trial: Clinical Trial of New Elastomer for Maxillofacial Prosthetics
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Multicenter Trial of CPE for Maxillofacial Prosthetics
Brief Summary: 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.
Detailed Summary:
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. Sponsor: University of Louisville
- 1. Non-inferiority of CPE material
- 2. Non-inferiority of quality of life of CPE material
- 3. Estimate of service life (longevity)
Current Primary Outcome: Non-inferiority of chlorinated polyethylene elastomer (CPE) material [ Time Frame: 10 month ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Louisville
Dates:
Date Received: July 21, 2005
Date Started: February 2005
Date Completion:
Last Updated: April 5, 2017
Last Verified: April 2017
