Blinded patient population

1. + Blinded patient population - Controlled, Randomized, Double-Blind, Multicenter, Prospective, Phase III Clinical Trial with Single Crossover Experimental variable (CPE) Experimental variable (CPE) Recruit patients: 67 at MDACC, 33 at TSRCC. Entry Health Q, Informed Consent 4 months + 4 months Indefinite time =======► - - C R O S S O V E R RANDOMIZE OutcomeMeasures: Incoming Clinical Q, Patient Evaluation Q, TOMCP, LASA, SF-8™ (Exit Q), Temp/humidity ______________________________________________________________________- Global question:Which prosthesis do you want to continue wearing? Patient wears the preferred prosthesis; follow-up by 4-month PEQ-Telephone Survey Outcome Measure: Outgoing Clinical Q, TOMCP, LASA,SF-8™ Temp/humidity Outcome Measure: Outgoing Clinical Q, TOMCP, Temp/humidity Outcome Measures: Incoming Clinical Q, Patient Evaluation Q, TOMCP, LASA, SF-8™ (Exit Q), Temp/humidity Visit 4 Visit 5 Visit 3 + Visit 6 4 months + 4 months Visits 1 & 2 =======► - Control variable (silicone) Indefinite time Control variable (silicone) Fabrication of 1st prosthesis by anaplastologist; ADLTQ Fabrication of 2nd prosthesis by anaplastologist; ADLTQ Q ≡ questionnaire “Multicenter Trial of CPE for Maxillofacial Prosthetics”