Comparison of a Custom-Made and a Thermoplastic Oral Appliance for the Treatment of Mild Sleep Apnea

Posted by Thomas Corwin, on February 8th, 2013

Vanderveken OM, Devolder A, Marklund M, Boudewyns AN, Braem MJ, Okkerse W, Verbraecken JA, Franklin KA, De Backer WA, Van de Heyning PH.

Source: Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, BE-2650 Edegem, Belgium. Olivier.Vanderveken@telenet.be

ABSTRACT

Rationale: 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.

Objectives: 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.

Measurements and Main 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.

Am J Respir Crit Care Med. 2008 Jul 15;178(2):197-202. Epub 2007 Aug 2.

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