Jonathan A. Parker, DDS, Salim Kathawlla, MD, Sue Ravenscraft, MD, Joan Fox,
MD
Kevin Komadina, MD, Keith Harmon, MD, Ted Berman, MD
Barry Cosens, MD, Barb Feider, RPT.
[In Sleep Vol. 22 (Suppl 1): S230-31; April 15, 1999.]
ABSTRACT
The current clinical research supports the effectiveness of mandibular repositioning appliances for treatment of primary snoring and mild obstructive sleep apnea. The research also hints that these devices can be effective for moderate obstructive sleep apnea. This is a prospective pilot study evaluating the effectiveness of a mandibular repositioning appliance used for the treatment of moderate obstructive sleep apnea. This study evaluated the changes in the signs and symptoms of obstructive sleep apnea in 15 patients. The evaluation and diagnostic testing were completed at an accredited sleep center (Methodist Hospital Sleep Disorders Center). The objective data for each subject in the study was taken from an overnight polysomnogram completed prior to treatment, and a follow-up polysomnogram was completed with the patient wearing the oral appliance throughout the night approximately 3 months later. An MSLT was completed on the following day, after each sleep study. Subjective information was gathered using questionnaires to evaluate patient compliance, daytime drowsiness, level of satisfaction with the appliance and changes in snoring.
The 15 subjects in this study included 13 males and 2 females, ranging in age from 30 to 72 years old. Each subject was evaluated by a physician at the sleep disorders center, and they were enrolled in the study after an informed consent process was completed. These subjects had an all night polysomnogram completed, and if the results of the initial polysomnogram and MSLT were within the parameters of the selection criteria, the patient was referred to the dental office for evaluation and confirmation of their participation in the study. The selection criteria for subjects in this study included: an RDI between 15 and 50 events per hour, an adequate number of teeth to retain the appliance, normal range of motion of the jaw, minimal or no TMJ symptoms, no evidence of narcolepsy, no cardiovascular problems, and periodic limb movements less than 100 per night. These patients had no previous treatment. Treatment was carried out using a mandibular repositioning device (PM Positioner). This device is made of a heat-sensitive acrylic material which fits over all maxillary and mandibular teeth. The mandible was positioned anteriorly approximately 65-75% of maximum protrusion with an increase in the vertical opening of approximately 5 mm between the incisal edges of the maxillary and mandibular incisors. Following placement of the appliance, the patient was seen every 10-14 days to update their progress and alter the mandibular position if the device was not adequately managing their symptoms. After approximately 3 months of treatment with the appliance, if the symptoms were reduced subjectively, the patient was referred to the sleep disorders center for a follow-up polysomnogram and MSLT with the appliance in place.
Fifteen subjects began treatment with the appliance, however, 2 patients discontinued treatment because they were unable to tolerate the device in their mouth. Therefore, 13 subjects completed the entire evaluation and treatment process for the study. The definition of successful treatment was a 50% decrease in the RDI while reducing the RDI to 10 events per hour or less. In addition, the patient must have subjective resolution of symptoms. The respiratory disturbance index prior to treatment ranged from 15 to 43 events per hour, with an average of 25.8. The respiratory disturbance index for patients using the appliance during the follow-up study revealed a range of 0.5 to 33 events per hour, with an average of 7.3 events per hour. The average of the lowest oxygen saturation level during the night, before treatment, was 78.2% and while using the appliance during the night, increased to 83.8%. The percentage of REM sleep during the pre-treatment polysomnogram averaged 14%, but this percentage increased to 18.8% of the night with the appliance in place. The MSLT prior to treatment and when using the appliance was virtually unchanged (no different). The Epworth Sleepiness Scores before treatment were at an average score of 12, and this subjective index after treatment was at a score of 6.4.
The preliminary data from this prospective study revealed that 10 out of
15 (67%) patients originally enrolled in this study were successfully treated
with the mandibular repositioning device. If we included only those subjects
who completed the pre and post-treatment polysomnograms and MSLT, then 10
out of 13 (77%) would be considered successful. Based on this preliminary
data, this mandibular repositioning appliance may be an effective treatment
alternative for management of moderate obstructive sleep apnea. However, a
larger sample size is necessary to compile adequate data to draw conclusions
from this pilot study. Note: We will continue to evaluate and treat a total
of 25 patients as we work towards completion of this study.
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