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

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.

• Authors: Olivier M Vanderveken, Annick Devolder, Marie Marklund, An N Boudewyns, Marc J Braem, Walter Okkerse, Johan A Verbraecken, Karl A Franklin, Wilfried A De Backer, Paul H Van de Heyning
• Journal: American journal of respiratory and critical care medicine (Am J Respir Crit Care Med) Vol. 178 Issue 2 Pg. 197-202 (Jul 15 2008) ISSN: 1535-4970 [Electronic] United States
• PMID: 17673699 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Topics

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