Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea

• 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-madedevice (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.

Nyckelord

excessive somnolence

oral appliances

polysomnography

sleep apnea

snoring

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