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

¹ Department of Otorhinolaryngology, Head and Neck Surgery, and ² Department of Pulmonary Medicine, University Hospital Antwerp, Edegem, Belgium; ³ Department of Orthodontics, Umeå University, Umeå, Sweden; ⁴ Department of Dentistry, University Hospital Antwerp, Edegem, Belgium; and ⁵ Department of Pulmonary Medicine, Umeå University, Umeå, Sweden

Correspondence and requests for reprints should be addressed to Olivier M. Vanderveken, M.D., Ph.D., University Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, BE-2650 Edegem, Belgium. E-mail: Olivier.Vanderveken{at}telenet.be

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/m²) 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.

Key Words: excessive somnolence • oral appliances • polysomnography • sleep apnea • snoring

AT A GLANCE COMMENTARY Scientific Knowledge on the Subject Mandibular advancement devices (MADs) have emerged as a conservative, noninvasive treatment for sleep-disordered breathing. To date, there is only limited information available comparing the efficacy of thermoplastic with custom-made MADs. What This Study Adds to the Field This randomized controlled cross-over study shows that a custom-made MAD is more effective in the treatment of sleep-disordered breathing than is a thermoplastic MAD.

 

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