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.

Condition	Intervention	Phase
Facial Neoplasms Head and Neck Neoplasms Head Injuries, Penetrating Birth Injuries	Device: Chlorinated polyethylene elastomer	Phase III

Further Study Details: 

Primary Outcomes: 1. Non-inferiority of CPE material; 2. Non-inferiority of quality of life of CPE material; 3. Estimate of service life (longevity)
Expected Total Enrollment:  100

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 , a) treats few patients, making the subspecialty unprofitable for manufacturers to develop new materials, b) offers fundamental rehabilitation and improvement in the quality of life to patients who may have exhausted personal or third party funding, and c) 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 a) experimental thermoplastic CPE, and b) control silicone (Silastic Adhesive A/MDX4-4210) materials for non-inferiority of CPE based on functional & 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.

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

-Requires treatment for developmental or acquired extraoral facial defect - Fully healed wound (6 months after surgery and/or radiation) - Defect no larger than 9 x 12 cm (3.5 x 4.5 inches, the diameter of a giant bronze flask) - Cognizant enough to answer questionnaires - Agrees to wear the prosthesis at least 6 hours per day - Agrees to use the prescribed adhesive (Epithane-3 – now called Daro Adhesive Extra Strength) and clean and store as instructed - Plans to be able to return to the research institution for a 10 month period - Able to manage prosthesis themselves or with caregiver for a 10 month period - Karnofsky score greater or equal to 60 www.hospicepatients.org/karnofsky.html - No framework or implant/magnet retention - No multiple recurrences of tumor - No hypersensitivity to adhesives or test materials - No current systemic or topical facial steroid treatment - Not legally blind - Not expected to have further surgeries to defect, radiation therapy, or other cytoreductive therapy over the next 10 months - No evidence of active skin condition/disease - Not an infectious risk patient

Please refer to this study by ClinicalTrials.gov identifier  NCT00123097

Kentucky
      University of Louisville, Louisville,  Kentucky,  40292-0001,  United States; Recruiting

Study chairs or principal investigators

Sudarat Kiat-amnuay, DDS MS,  Study Chair,  University of Texas Dental Branch   
Mark S Chambers, DMD MS,  Study Chair,  MD Anderson Cancer Center, Dept. of Head & Neck Surgery   
James D Anderson, DDS MScD,  Principal Investigator,  Toronto Sunnybrook Regional Cancer Centre   
Lawrence Gettleman, DMD, MSD,  Principal Investigator,  University of Louisville, School of Dentistry   

Study ID Numbers:  NIDCR-14543; 5U01 DE-014543
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00123097
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26