| 1625 Design of Multicenter Phase III Clinical Trial for Maxillofacial Prosthetics | ||
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L. GETTLEMAN, University of Louisville, KY, USA, S. KIAT-AMNUAY, University of Texas - Houston/Health Science Center, Dental Branch, USA, D.A. JOHNSTON, Baylor University, Department of Mathematics, Waco, TX, USA, J.D. ANDERSON, University of Toronto, Toronto Sunnybrook Regional Cancer Centre, Canada, and R.F. JACOB, University of Texas - Houston/Health Science Center, M.D. Anderson Cancer Center, USA Chlorinated polyethylene (CPE) was developed by us in the 1980s as a low-cost alternative skin replacement material for costly silicone rubber maxillofacial prostheses. CPE is thermoplastic, molded in gypsum at 110ºC, followed by surface coloration and lamination. A Phase II clinical trial, conducted by Gulf South Research Institute at Charity Hospital/New Orleans, showed equivalency to the silicone control material. Objectives: A Phase III multicenter clinical trial grant has been awarded to the University of Louisville, the University of Texas-Houston Dental Branch, and 3 cancer centers: J.G. Brown Cancer Center (Louisville), M.D. Anderson Cancer Center (Houston), and Toronto Sunnybrook Regional Cancer Centre (Toronto). Hypothesis: determine non-inferiority of the CPE (experimental) versus silicone (control) material, based on functional/subjective characteristics and quality of life of the patient. Methods: Outcome measures are: a) anaplastologist/ dental laboratory technician; b) 2 independent prosthodontists; c) failure evaluation, and d) the patient for functional/subjective details, and e) the Toronto Outcomes Measure of Craniofacial Prostheses for quality of life. Longevity is estimated after the crossover trial; patients wear the better prosthesis as long as they wish. Results: Guided by 3 power analyses from previous studies (patient satisfaction: 71; frayed margin length: 65; Toronto Quality-of-Life: 71 patients), the trial treats 100 extraoral maxillofacial prosthetic patients in a randomized single-crossover double-blind design to determine non-inferiority. Control prostheses of Medical Silastic Adhesive A/MDX4-4210 are compared with low-cost CPE; both prostheses are made to the same sculpture, using the same skin adhesive. Each prosthesis is randomly and alternately delivered to the patient, worn 4 months, with outgoing and incoming evaluations performed. Conclusions: A unique clinical trial design for maxillofacial prosthetics has been devised, in this case to compare facial materials. Other variables are possible in facial prosthetics for clinical trials using this experimental design. Supported by cooperative agreement 1-U01-DE014543-01A1 from the NIDCR, NIH. | ||
| Seq #185 - Removable/Maxillofacial Prosthodontics and Articulators 8:00 AM-9:30 AM, Friday, 12 March 2004 Hawaii Convention Center 321-B | ||
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