Comparison of two dental devices for treatment of obstructive sleep apnea syndrome (OSAS).

Previous case reports have indicated dental devices can be an effective nonsurgical treatment for snoring and obstructive sleep apnea. This pilot study evaluated the effectiveness of two intraoral devices in reducing the Respiratory Disturbance Index (RDI) and Epworth Sleepiness Scale (ESS) scores in a group of 24 adult volunteers with a history of loud snoring. Subjects were randomly assigned to two groups. Twelve subjects were fitted with a dental device designed to increase vertical dimension and protrude the mandible (device A). The other 12 subjects received a different device designed to minimally increase vertical opening without protruding the mandible (device B). Unattended home sleep monitoring (Edentrace II Digital Recorder, Edentech Corp.) was used to compute RDI at two time periods: (T0) before using any dental device and (T1) while using a dental device 2 weeks after the initial delivery date. The mean RDI and ESS scores at T0 for subjects in the device A group were 35.6 +/- 28.4 and 12.0 +/- 3.9, respectively. Means for the same measures at T1 were 21.1 +/- 21.4 and 8.2 +/- 4.0. For subjects in the device B group, means for RDI and ESS scores at T0 were 36.5 +/- 43.7 and 13.0 +/- 4.5, the means at T1 were 46.8 +/- 47.0 and 12.5 +/- 5.7. The effectiveness of the two devices was estimated by comparing the difference in RDI scores from T0 to T1 for the 10 subjects who were using device A and completed the study and the 8 subjects who were using device B and completed the study. Six subjects withdrew for various reasons. From T0 to T1, device A reduced RDI scores in 9 of 10 subjects, with a mean reduction in RDI of 14.5 (p < or = 0.05) and in ESS score of 3.8 (p < or = 0.005). Device B showed no change or an increased RDI score in 8 of 8 subjects. Seven of the eight subjects who showed no improvement in RDI with device B were then fitted with device A. Four of these seven subjects showed a reduction in RDI and five showed a reduction in ESS after using device A for 2 weeks. The mean reduction in RDI and ESS was 2.4 +/- 19.8 and 2.4 +/- 3.0, respectively. Hence, we conclude that a dental device that advances the mandible and increases the vertical dimension to open the upper airway is more effective in reducing the number of apneic and snoring events during sleep than one which does not.

RCT Entities:   Population Interventions Outcomes