Clinical trial of chlorinated polyethylene for facial prosthetics.
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.
Kiat-amnuay
Sudarat
S
Department of Restorative Dentistry and Biomaterials, University of Texas Dental Branch at Houston, Texas, USA.
Jacob
Rhonda F
RF
Chambers
Mark S
MS
Anderson
James D
JD
Sheppard
Rachel A
RA
Johnston
Dennis A
DA
Haugh
Gilbert S
GS
Gettleman
Lawrence
L
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
D020724:Elastomers; D011095:Polyethylenes; D011140:Polyurethanes; D012826:Silicone Elastomers; C045578:polyethylene chloride; C078082:silastic 4-4210