Published ahead of print on August 2, 2007, doi:10.1164/rccm.200701-114OC Am. J. Respir. Crit. Care Med., Volume 178, Number 2, July 2008, 197-202 A more recent version of this article appeared on July 15, 2008
Submitted on January 21, 2007 Comparison of a Custom-Made and a Thermoplastic Oral Appliance for the Treatment of Mild Sleep ApneaOlivier M Vanderveken1*,1 Department of Otorhinolaryngology, Head and Neck Surgery, University of Antwerp, Antwerp University Hospital, Antwerp, Belgium; Department of Pulmonary Medicine, University of Antwerp, Antwerp University Hospital, Antwerp, Belgium, 2 Department of Pulmonary Medicine, University of Antwerp, Antwerp University Hospital, Antwerp, Belgium, 3 Department of Orthodontics, Umea University, Umea, Sweden, 4 Department of Otorhinolaryngology, Head and Neck Surgery, University of Antwerp, Antwerp University Hospital, Antwerp, Belgium, 5 Department of Dentistry, University of Antwerp, Antwerp University Hospital, Antwerp, Belgium, 6 Department of Pulmonary Medicine, Umea University, Umea, Sweden * To whom correspondence should be addressed. E-mail: olivier.vanderveken{at}telenet.be.
Background 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. 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 wash-out interval. Results A total of 35 patients (29 males; age: 49±9 y; apnea/hypopnea-index (AHI) 13±11/h; BMI 28±4 kg/m2) finished 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. The total number of failures even amounts up to 69%, whereas the majority (63%) of these were successfully treated with the custom-made device. At the end, 82% of the patients preferred the custom-made device, 9% had no preference (p<0.0001). Conclusions In this study, a custom-made device turns 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 be used as a screening tool to find good candidates for mandibular advancement therapy. Key words: Excessive Somnolence, Mandibular Advancement Devices, Polysomnography, Sleep Apnea, Snoring.
This article has been cited by other articles:
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
