JADA Continuing Education
The role of oral appliances in treating obstructive sleep apnea
NEDA MOHSENIN,
MINA T. MOSTOFI, D.M.D. and
VAHID MOHSENIN, M.D.
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ABSTRACT
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Background. Sleep-related breathing disorders are common and often are associated with vascular complications such as arterial hypertension, coronary heart disease and stroke. The most widely studied form of these disorders is obstructive sleep apnea. Patients usually are diagnosed with obstructive sleep apnea years after the onset of symptoms, which generally are nonspecific and include excessive daytime sleepiness, chronic fatigue and habitual snoring. The risk factors for sleep apnea are obesity, advancing age, male sex and maxillofacial abnormalities. This review focuses on the diagnosis and treatment of obstructive sleep apnea and, specifically, on the utility of oral appliances in the management of this disorder.
Methods. The review is based on a MED-LINE search for articles in English on this topic. The article discusses results of randomized studies and prospective case series.
Clinical Implications. Several treatment options are quite effective. Nasal continuous positive airway pressure, with an overall acceptance rate of 70 percent, is the most widely used treatment modality. Maxillofacial surgery, although effective, is reserved for patients who have not responded to the more conventional therapies. Newer methods include application of oral appliances. Oral appliances have been shown to alleviate the severity of respiratory disturbances during sleep by about 60 percent, with an overall acceptance rate of 75 percent. The long-term complications generally are minor and are related to occlusal changes and temporomandibular joint discomfort.
Conclusions. With the advent of oral appliances, dentists are increasingly involved in managing the care of patients with sleep-related breathing disorders. Further studies are needed to determine the long-term complications of this type of intervention for the treatment of sleep-related breathing disorders.
Breathing disorders during sleep can cause significant health problems that are associated with a high morbidity and a high risk of mortality.1,2 The most widely studied breathing disorders during sleep are obstructive sleep apnea syndrome, central hypoventilation and Cheyne-Stokes respiration. Obstructive sleep apnea, or OSA, the most common type, is characterized by repeated episodes of upper-airway obstruction during sleep.2,3 (As central hypoventilation and Cheyne-Stokes respiration are uncommon, we will not discuss them further here.)
Dentists play an increasing role in managing the care of patients with sleep-related breathing disorders.
The primary effects of OSA are frequent arousals and repeated hypoxemia during sleep. Patients with OSA commonly complain of excessive daytime sleepiness and fatigue, as well as unrefreshing sleep and neurocognitive dysfunction.4,5 Several studies have demonstrated an association between OSA and arterial hypertension, coronary heart disease and stroke.69 OSA also is associated with a poor quality of life and impaired work performance.1014 Sleep apnea syndrome, which is defined as having more than five apneas or hypopneas per hour of sleep and hypersomnia, has been demonstrated in 4 percent of the adult population in the United States and elsewhere.3,15 To place the prevalence of this condition in perspective, OSA is more common than asthma and diabetes mellitus in adults. The early epidemiologic studies of OSA included only men and, thus, reported a male preponderance. However, recent studies of the general population have reported a male-to-female prevalence ratio of about 2:1 to 3:1.2
The risk factors for the development of OSA are obesity, maxillofacial abnormalities such as retrognathia and micrognathia, obstructive tonsils and macroglossia. Increasing age also is associated with a higher prevalence of OSA. The patency of the upper airway during sleep depends on the upper airways size and stiffness and on neuronal control of the pharyngeal muscles. OSA tends to be more severe when the affected person sleeps in a supine position, in large part because of the effect of gravity on the tongue and other soft tissue and the mandible.16,17
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DIAGNOSIS OF SLEEP-RELATED BREATHING DISORDERS
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The dentist should obtain a thorough medical history and conduct a physical examination with specific attention to risk factors such as body mass index and upper airway anatomical abnormalities. The degree of sleepiness can be assessed by administration of a short questionnaire such as the Epworth Sleepiness Scale.18 If initial findings from the medical and sleep history and physical examination raise sufficient suspicion of sleep-related breathing disorders, the dentist should refer the patient to a sleep laboratory for further investigation. The standard of care requires a formal polysomnography that includes monitoring sleep stages, respiration, nasal and oral airflows, oxygen saturation, electrocardiography and electromyography.19 No uniform consensus exists about a screening method that would be sufficiently sensitive or specific to detect sleep-related breathing disorders without being as complex as formal polysomnography.
The severity of sleep apnea is reported as the total number of apneas and hypopneas per hour of sleep and is expressed as a score on either the respiratory disturbance index, or RDI, or the apnea-hypopnea index, or AHI. The American Academy of Sleep Medicine classifies the severity of sleep apnea as follows:
- mild: RDI score between five and 15 apneas or hypopneas per hour of sleep;
- moderate: RDI score between 16 and 30;
- severe RDI score higher than 30.20
Treatment is required when the RDI score is higher than five per hour of sleep in the presence of symptoms and when the RDI score is higher than 30 per hour of sleep regardless of symptoms.
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TREATMENT MODALITIES
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General treatment.
Several general treatment measures can be implemented along with the more specific treatments of OSA. These consist of altering the sleep position, avoiding use of alcohol and sedative medications before sleep, relieving nasal congestion and reducing weight. In a patient who has mild, position-dependent OSA and minimal symptomatology, the condition often can be managed if the patient is trained to sleep on his or her side. Avoiding use of alcohol and sedatives three to four hours before bedtime can prevent further relaxation of upper airway muscles and exacerbation of existing OSA.2123 A modest weight reduction in an obese person can significantly improve scores on apnea indexes, arterial oxygen saturation, sleep architecture and daytime performance.2426 A 10 percent weight reduction is expected to decrease the score on the AHI by 33 percent. 27 Treatment of concomitant lung disease and smoking cessation improves gas exchange during sleep.
Specific treatments.
Most specific treatment modalities focus on maintaining upper-airway patency during sleep. These include continuous positive airway pressure, or CPAP, devices that splint the upper airway pneumatically during sleep, a variety of surgical procedures for improving upper-airway anatomy and oral appliances that splint the upper airway open mechanically during sleep. The desired treatment outcomes are optimized sleep architecture and gas exchange and improved daytime symptoms. The selection of a particular therapeutic modality depends on the severity of the patients sleep apnea, his or her age and his or her upper-airway anatomy.
The most common therapy for OSA is pressurization of the upper airway during sleep with the use of CPAP. Although CPAP is highly effective, it is somewhat cumbersome and requires a period of acclimation before it can be tolerated. The long-term compliance with this treatment modality is on the order of 60 to 70 percent.28,29 Surgical options are viable alternatives for some patients with OSA. Because multiple sites of obstruction can be present in OSA, a multistaged approach generally is required for optimal outcomes. Practitioners should be careful in patient selection and should ensure that they evaluate the upper airway fully and appropriately before surgery, by means such as fiberoptic nasopharyngoscopy and lateral cephalometric radiography or other imaging techniques.30 The Stanford two-phase surgical protocol with uvulopalatopharyngoplasty and/or genioglossal advancement and hyoid myotomy as phase 1 had an overall response rate of 61 percent in one study.31 Response was defined as a postsurgical RDI score of fewer than 20 per hour and a reduction of RDI by at least 50 percent. Patients whose phase 1 surgery failed underwent phase 2 reconstruction, which consisted of maxillo-mandibular osteotomy. The response rate for this group was 97 percent.32
Although a systematic surgical approach in the treatment of OSA has been shown to be effective, these surgical procedures are not without risk and complications and require careful planning and patient education. A detailed discussion on the efficacy of CPAP treatment and surgical procedures for OSA is beyond the scope of this article; for this information, the reader should refer to reviews.30,33 This article will focus on mechanical means of increasing the upper airways diameter during sleep.
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MECHANISM OF ACTION OF ORAL APPLIANCES
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The use of oral devices in the treatment of sleep-related breathing disorders dates back to the early 1900s.34 There are two main appliance groups: tongue repositioning devices and mandibular repositioning appliances, or MRAs. Since most of the recent controlled studies have used MRAs,35,36 we will not discuss tongue-repositioning devices here.
Several designs of MRAs using different materials are available. These devices are made primarily of clear acrylic and are snapped onto the teeth. The acrylic appliance pieces are connected with adjustable rods and screws or with plastic extension arms in varying lengths (Figure
). Most appliances allow for mouth opening and side-to-side movement of the mandible. The oral appliance initially is adjusted to 75 percent of the protrusive range of the mandible. However, several initial fine adjustments may be necessary to optimize the advancement and to minimize discomfort. MRAs are designed to advance the mandible in relationship to the maxilla, creating more space behind the tongue and stabilizing the pharyngeal lumen during sleep.

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Figure. Mandibular repositioning appliances. A. A lateral view of a fully adjustable dynamic appliance (Klearway, The University of British Columbia, Vancouver, Canada). (Photo courtesy of Alan A. Lowe.) B. Palatal view of Klearway showing the jackscrew used to advance the jaw. (Photo courtesy of Alan A. Lowe.)
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The key anatomical relationships between upper-airway structure and mandibular advancement are shown in the box
. During sleep, and whenever the person is in the supine position, the mandible tends to move inferiorly and posteriorly.37 The vertical mandibular opening during sleep is larger in patients with OSA than in healthy adults.37 This vertical mandibular posture is associated with a decreased pharyngeal diameter and an increase in upper-airway resistance.38,39 Previous studies using fiber-optic endoscopy, computerized tomography and magnetic resonance imaging have demonstrated that patients with OSA have an elliptical upper airway shape with the long axis oriented in the lateral direction.40,41 In contrast, snorers have a circular airway, and in normal subjects the long axis is oriented in the sagittal plane.40,41 In a study using video endoscopy, the mandibular protrusion resulted in a significant increase in airway diameter, primarily in the oropharyngeal cross-sectional area, in both obese and nonobese subjects.42 In this study, an average of 50 percent of maximal protrusion produced a 33 percent increase in the upper airway caliber, whereas maximum protrusion resulted in almost a doubling of the upper airway cross-sectional area. In the latter study, during mandibular and tongue protrusion, the shape of the upper airway changed from an axially oriented ellipse to a more circular contour. This was achieved through vertical displacement of the epiglottis, tongue and soft palate.
In another study using a Herbst-type MRA in 37 patients with OSA in the supine position, cephalometric data demonstrated a significant increase in postlingual airway (19 percent, P = .003) and oropharyngeal airway (13 percent, P = .015) with a decrease in the distance between the hyoid bone and the mandibular plane (17 percent, P = .0001).43 These changes in upper-airway dimensions were associated with an improvement of AHI from a mean of ± a standard deviation, or SD, of 34 ± 22 per hour to 10 ± 5 (SD) per hour, P = .001.
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CLINICAL EFFECTIVENESS OF MANDIBULAR REPOSITIONING APPLIANCES
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Table 1
summarizes the results from a series of recent prospective case studies and randomized controlled trials of MRAs.35,36,4451 Clark and colleagues44 prospectively studied the efficacy of and compliance with a Herbst-type MRA in 24 patients with moderate to severe OSA over a three-year period. They found statistically and clinically significant reductions in RDI from a mean of 48 ± 34 (SD) to 12 ± 21 (SD) per hour (P < .05). Fifty-two percent of the patients still were using the appliance successfully at 36 months. In another study using a similar device in 19 patients, RDI decreased from a mean ± standard error of the mean, or SEM, of 35 ± 5 per hour to 13 ± 2 per hour (P < .05).45 Thirteen of 14 subjects for whom follow-up data were available had continued to use the device for a mean period of two years (range, 1 year-3.5 years).
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TABLE 1 STUDIES ON THE EFFECT OF MANDIBULAR REPOSITIONING APPLIANCES AND CONTINUOUS POSITIVE AIRWAY PRESSURE IN OBSTRUCTIVE SLEEP APNEA.
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A recent study using a two-piece adjustable appliance (Klearway, The University of British Columbia, Vancouver, Canada) showed a significant reduction in the mean RDI from the baseline of 33 ± 2 (SEM) to 12 ± 2 per hour after insertion (P < .05) in a group of 20 patients.52 The oral appliance increased the velopharyngeal area by approximately 35 percent.52 Mehta and colleagues35 published in 2001 the first randomized controlled trial of a two-piece MRA versus a control plate (without advancement), in which they showed a significant improvement in RDI and subjective daytime sleepiness. Similarly, another randomized controlled trial showed that in addition to a significant decrease (56 percent) in RDI score brought about by use of a two-piece MRA, there also was an improvement in subjective report of sleepiness and in objectively measured sleep latencies (a measure of sleepiness) in a group of 73 subjects with an average RDI score of 27 per hour.36
Three randomized controlled trials have compared use of MRAs with CPAP. In a study by Ferguson and colleagues,47 both a one-piece MRA and CPAP decreased the RDI significantly, but CPAP was much more effective than MRA (78 percent with CPAP versus 50 percent with the MRA). Similarly to this study, two subsequent crossover studies comparing one-piece and two-piece MRAs with CPAP showed that CPAP was more efficacious than MRA,50,51 but there was greater use of MRA than of CPAP.50 In other words, patients were more likely to comply with the use of the MRA than with use of CPAP.
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PATIENT SELECTION AND PREDICTORS OF MANDIBULAR REPOSITIONING APPLIANCES EFFECTIVENESS
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The patients with symptomatology suggestive of OSA should undergo a sleep study to determine the presence and assess the severity of OSA so that the practitioner can formulate the best therapeutic approach. The ideal candidate for an oral appliance is a symptomatic patient who is not obese, who snores or has mild-to-moderate OSA, who has an adequate protrusive range of motion of the mandible and who has adequate dentition. In addition, oral appliances can be used with patients who cannot tolerate CPAP or in those with whom surgical intervention failed.
There is no reliable way of predicting a patients response to the use of a mandibular advancement device. However, measurements obtained from cephalometric imaging may prove to be a reliable method for selecting patients who may benefit from using these devices.45 A recent study using cephalometric and physiological methods demonstrated potential predictors of the efficacy of an adjustable oral appliance for treating OSA.53 These included younger subjects with lower body mass index, a longer maxilla, a smaller oropharynx, a smaller overjet, less erupted maxillary molars and a larger ratio of vertical airway length to the cross-sectional area of the soft palate in the form of either a longer pharynx or smaller soft palate (Table 2
). In a similar study, the perpendicular distance between the hyoid bone and the mandibular plane was the only cephalometric variable associated with a successful clinical outcome.54
Generally, oral appliances are more effective in patients with mild-to-moderate sleep apnea. This thesis is supported in a study by Marklund and colleagues,49 who specifically evaluated the efficacy of mandibular advancement devices in OSA patients with varying levels of severity of sleep apnea. In this prospective study, they demonstrated a significant reduction in AHI in patients with a wide range of OSA severities, but the greatest improvement was seen in patients with mild-to-moderate disease. In contrast, a study by Henke and colleagues55 of 28 patients with OSA showed that the severity of OSA and the site of airway closure did not predict the efficacy of the device. In this study, the patients with severe sleep apnea (mean RDI score of 53 per hour) had a mean reduction of 53 percent in their RDI scores.55 Thus, the variables of polysomnographic severity of OSA and the site of airway closure should not be used to exclude patients from receiving treatment with oral appliances. However, the therapeutic goals should be to ameliorate the daytime symptoms of OSA, to lower the RDI scores to less than 10 per hour and to optimize arterial oxygen saturation. It should be noted that oral appliances could be used in conjunction with other treatment modalities. For example, a patient with partial response to CPAP and an air leak through the mouth can potentially benefit from concomitant use of oral appliances to further lower the RDI scores and alleviate the mouth leak. However, further studies are needed to examine the efficacy of a combined approach in patients with difficult-to-treat OSA.
The success of mandibular advancement in treating OSA does not depend to any great extent on the type of prosthetic device used, because both one-piece and two-piece devices have proven to be effective (Table 2
).44,45,48,52,56 However, for best results, the dentist should conduct a thorough initial evaluation and regular follow-up and collaborate with a sleep specialist to determine the best modes of treatment.
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COMPLICATIONS OF ORAL APPLIANCE USE
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During the initial period of adjusting to use of the oral appliance, patients usually complain of soreness of the jaws or teeth, either excessive salivation or dry mouth and minor occlusal changes. However, after two to three months of use, most patients will be able to tolerate and comply with proper use of the appliance. In a prospective study by Clark and colleagues,56 40 percent of 53 responding patients reported occlusal changes. These patients had been treated with a Herbst-type MRA, in which the mandible was advanced to 75 percent of its maximal protrusive range. The investigators concluded that one in three patients would develop some minor transient complications of the jaw and mouth.
The more insidious and potentially problematic complications of long-term mandibular protrusion may be related to temporomandibular joint and dental occlusion. During the initial follow-up period, the patient should be examined for maximal jaw-opening ability, and the dentist should perform auscultation for temporomandibular joint sounds and palpation of the right and left masseters and temporalis muscles for tenderness. Specifically, the dentist should evaluate the presence or lack of occlusal contact in maximum inter-cuspation. This can be minimized by full-arch occlusal coverage. However, it should be noted that most follow-up studies have been of relatively short duration; therefore, long-term complications of oral appliances in the treatment of OSA should be examined further.
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CONCLUSION
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Oral appliances have been shown to offer an alternative treatment to surgical intervention and CPAP in patients with OSA. Dentists play an increasing role in managing the care of patients with sleep-related breathing disorders. To improve the efficacy of oral appliances and to minimize the complications of using them, only experienced practitioners should offer this treatment modality. Further, studies are needed that allow for a better selection of patients and for ways to minimize the long-term complications of oral appliances in the treatment of sleep-related breathing disorders.

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Dr. Vahid Mohsenin is the director, Yale Center for Sleep Medicine, Yale University School of Medicine, 40 Temple St., Suite 3C, New Haven, Conn. 06510, e-mail "vahid.mohsenin{at}yale.edu". Address reprint requests to Dr. Mohsenin.
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