Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea.
BACKGROUND
The efficacy of immediate adaptation of mandibular advancement devices made of thermoplastic material as a treatment option for sleep-disordered breathing (SDB) has been demonstrated in clinical studies. To date, there have been no studies comparing the efficacy of such prefabricated devices with custom-made devices.


OBJECTIVE
Our purpose was to compare the efficacy of both types of devices in patients with SDB.


METHODS
A randomized controlled cross-over trial, comprising 4 months of treatment with a thermoplastic and a custom-made device, with a 1-month washout interval.


RESULTS
A total of 35 patients (29 males; age, 49 +/- 9 yr; apnea-hypopnea index [AHI], 13 +/- 11 events/h; body mass index, 28 +/- 4 kg/m(2)) completed the protocol. AHI was only reduced with the custom-made device (P = 0.005). In addition, this device reduced snoring to a greater extent than the thermoplastic device. The success rate was higher with the custom-made device (60 vs. 31%; P = 0.02). One-third of the patients demonstrated compliance failure with the thermoplastic device, mainly because of insufficient overnight retention. Total failure rate with the thermoplastic device was 69%, whereas the majority (63%) of these were successfully treated with the custom-made device. At the end of the study, 82% of the patients preferred the custom-made device, and 9% had no preference (P < 0.0001).


CONCLUSIONS
In this study, a custom-made device turned out to be more effective than a thermoplastic device in the treatment of SDB. Our results suggest that the thermoplastic device cannot be recommended as a therapeutic option nor can it be used as a screening tool to find good candidates for mandibular advancement therapy.
Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, BE-2650 Edegem, Belgium. Olivier.Vanderveken@telenet.be
Olivier M
OM
Vanderveken
Annick
A
Devolder
Marie
M
Marklund
An N
AN
Boudewyns
Marc J
MJ
Braem
Walter
W
Okkerse
Johan A
JA
Verbraecken
Karl A
KA
Franklin
Wilfried A
WA
De Backer
Paul H
PH
Van de Heyning
D000704:Analysis of Variance; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D019186:Mandibular Advancement / Q000295:instrumentation*; D008875:Middle Aged; D009968:Orthodontic Appliances, Removable; D017286:Polysomnography; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D012913:Snoring / Q000628:therapy*