title: Clinical trial of chlorinated polyethylene for facial prosthetics.
abstract: OBJECTIVE
  Extraoral maxillofacial prostheses have been fabricated with silicone elastomer for 50 years with few improvements. The objective of this controlled, randomized, prospective, double-blind, single-crossover, multicenter, phase III clinical trial was to determine the noninferiority of chlorinated polyethylene elastomer (CPE) to silicone elastomer for fabricating prostheses.
  
  
  METHODS
  Forty-two patients were randomly assigned to wear a custom-made prosthesis fabricated from both materials for 4 months and asked to rate their satisfaction (0 = not satisfied, 10 = completely satisfied). Many other measures of prosthesis performance were investigated (see online appendices).
  
  
  RESULTS
  Of the 28 patients who completed the study, 68% had used silicone prostheses previously. Overall, patients rated the silicone prosthesis higher than CPE (difference: 2.2, 95% confidence interval [CI]: 0.9 to 3.6, P = .017). Previous users had a stronger preference for silicone (difference: 3.3, 95% CI: 1.7 to 4.9, P = .001), while the 9 new users rated the two materials similarly (difference: 0.0, 95% CI: -2.1 to 2.1, P = 1.00).
  
  
  CONCLUSIONS
  The noninferiority of CPE could not be established because of the early termination of the trial. Previous users of silicone prostheses preferred those made of silicone. However, new users expressed no preference between prostheses fabricated with the low-cost CPE or silicone. The authors have developed original clinical trial methodology for assessing extraoral maxillofacial prostheses.
authors.affiliation: Department of Restorative Dentistry and Biomaterials, University of Texas Dental Branch at Houston, Texas, USA.
authors.forename: Sudarat
authors.initials: S
authors.lastname: Kiat-amnuay
authors.forename: Rhonda F
authors.initials: RF
authors.lastname: Jacob
authors.forename: Mark S
authors.initials: MS
authors.lastname: Chambers
authors.forename: James D
authors.initials: JD
authors.lastname: Anderson
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Sheppard
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Johnston
authors.forename: Gilbert S
authors.initials: GS
authors.lastname: Haugh
authors.forename: Lawrence
authors.initials: L
authors.lastname: Gettleman
mesh_terms: D000328:Adult; D001294:Attitude to Health; D018592:Cross-Over Studies; D004311:Double-Blind Method; D020724:Elastomers / Q000737:chemistry*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011095:Polyethylenes / Q000737:chemistry*; D011140:Polyurethanes / Q000737:chemistry; D011446:Prospective Studies; D019736:Prostheses and Implants; D017797:Prosthesis Coloring; D011474:Prosthesis Design; D017755:Prosthesis Fitting; D011788:Quality of Life; D012826:Silicone Elastomers / Q000737:chemistry; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D020724:Elastomers; D011095:Polyethylenes; D011140:Polyurethanes; D012826:Silicone Elastomers; C045578:polyethylene chloride; C078082:silastic 4-4210