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

Am J Respir Crit Care Med. 2008 Jul 15;178(2):197-202. doi: 10.1164/rccm.200701-114OC. Epub 2007 Aug 2.


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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Analysis of Variance
  • Cross-Over Studies
  • Female
  • Humans
  • Male
  • Mandibular Advancement / instrumentation*
  • Middle Aged
  • Orthodontic Appliances, Removable*
  • Polysomnography
  • Sleep Apnea, Obstructive / therapy*
  • Snoring / therapy*