A Look at the 2015 Oral Appliance Clinical Practice Guideline

Published on July 30, 2015

Obstructive sleep apnea (OSA) is recognized by the medical community as a serious disease that requires diligent care and treatment by a dedicated team. Over the past 20 years, dentists have become a bigger part of this sleep team, working alongside sleep physicians, primary care providers, and other medical colleagues to facilitate care and optimize the protocol for how and why specific treatment options are administered. Oral appliance therapy has emerged as an increasingly common treatment modality for those who do not or cannot adhere to the traditionally prescribed continuous positive airway pressure (CPAP) therapy. Today, many dentists play a pivotal role in treating OSA with oral appliances.

To provide the best patient care and guide the successful administration of oral appliance therapy, the American Academy of Sleep Medicine (AASM) and the American Academy of Dental Sleep Medicine (AADSM) this summer unveiled the first joint Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy, which updates the practice parameters published by the AASM in 2006.¹ The guideline comprises the best practices for administering oral appliance therapy to achieve optimal outcomes.

Ultimately, the six practical recommendations in the 2015 update validate the effectiveness of oral appliance therapy, suggest best practices for administering treatment, and clarify the roles for both dentists and physicians in the patient care continuum.

Clinical Recommendations

The AASM and AADSM support six clinical recommendations for administering oral appliance therapy to patients with snoring or obstructive sleep apnea. The grades show the strength of each recommendation weighed against factors such as the benefits of the treatment and potential risks.

1. We recommend that sleep physicians prescribe oral appliances, rather than no therapy, for adult patients who request treatment of primary snoring (without OSA). (STANDARD) Quality of Evidence: High
2. When oral appliance therapy is prescribed by a sleep physician for an adult patient with OSA, we suggest that a qualified dentist use a custom, titratable appliance over non-custom oral devices. (GUIDELINE) Quality of Evidence: Low
3. We recommend that sleep physicians consider prescription of oral appliances, rather than no treatment, for adult patients with obstructive sleep apnea who are intolerant of CPAP therapy or prefer alternate therapy. (STANDARD) Quality of Evidence: Moderate
4. We suggest that qualified dentists provide oversight—rather than no follow-up—of oral appliance therapy in adult patients with obstructive sleep apnea, to survey for dental-related side effects or occlusal changes and reduce their incidence. (GUIDELINE) Quality of Evidence: Low
5. We suggest that sleep physicians conduct follow-up sleep testing to improve or confirm treatment efficacy, rather than conduct follow-up without sleep testing, for patients fitted with oral appliances. (GUIDELINE) Quality of Evidence: Low
6. We suggest that sleep physicians and qualified dentists instruct adult patients treated with oral appliances for obstructive sleep apnea to return for periodic office visits—as opposed to no follow-up—with a qualified dentist and a sleep physician. (GUIDELINE) Quality of Evidence: Low

The guideline also recognizes that the successful delivery of an oral appliance must be administered by a dentist and requires technical skill, acquired knowledge, and clinical judgment regarding outcomes and risks—all of which are gleaned from ongoing education and practical experience. The AADSM is one of several organizations that has addressed this issue over the past decade through the development and delivery of educational programs in dental sleep medicine. The AADSM also established a certifying examination in dental sleep medicine that is now administered and maintained by the American Board of Dental Sleep Medicine. As physicians diagnose and subsequently refer patients with OSA to select dentists, they should evaluate criteria to assess the dentists’ general professional standing, such as updated licensure and liability coverage, as well as more in-depth education by nonprofit organizations or experience in dental sleep medicine.

Why the Update Is Needed

Past practice parameters for oral appliance therapy were issued by the AASM alone and based on a small body of oral appliance research. However, since the last practice parameters update in 2006, the clinical use of oral appliance therapy for the treatment of snoring and OSA—and the scientific literature on treatment outcomes—has increased remarkably. Although CPAP remains the most efficacious treatment for OSA, and therefore is still considered the first-line treatment option, dentists today are offering effective oral appliance therapy for thousands of patients—providing convenient, portable treatment with a therapeutic adherence rate that is often better than CPAP.

The Process

To develop this guideline, the AASM and AADSM commissioned a task force of seven experts, including three sleep medicine physicians and two dentists with expertise in the use of oral appliances. A comprehensive and systematic search of the scientific literature was conducted, allowing the guideline to be based on the review of more than 50 published studies evaluating oral appliance therapy in a variety of practice settings and patient populations.

The task force members followed a rigorous, extensive process to draft the recommendations. The PICO method (Patient, Population, or Problem; Intervention; Comparison; Outcomes) was used to address common questions related to treatment with oral appliances. The team extensively analyzed the studies that met inclusion criteria, using state-of-the-art methods to perform an 11-question PICO analysis and grading the evidence according to a modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. For each question, meta-analysis was performed by pooling data across studies for each outcome measure. The task force then developed recommendations, which were made available in February 2015 for a public comment period. After final revisions were made, the revised guideline was approved by the board of directors of both the AASM and AADSM.

Notable Findings

The guideline is significant for many reasons, and three of the most interesting findings for practitioners can be traced back to PICO questions on adherence, cardiovascular outcomes, and quality-of-life (QOL) impacts.

• Adherence. The data bears out a well-established truth: CPAP decreases sleepiness, improves daily functioning, and restores memory. It is superior to oral appliance therapy in improving the apnea-hypopnea index (AHI) and lowering both the arousal index and the oxygen desaturation index (ODI). However, data suggest that the efficacy gap between CPAP and oral appliance therapy may be closed when adherence is taken into consideration. Even when using a minimal definition of adherence—only 4 hours a night—data show that up to 83% of patients may be non-adherent to their CPAP treatment.² As part of the guideline development process, a meta-analysis was performed on 11 randomized controlled trials that evaluated adherence rates. Results show that subjective adherence with oral appliance therapy is better overall than objective adherence with CPAP in adult patients with OSA. This clinical reality has led researchers to develop the mean disease alleviation calculation, which suggests that the overall therapeutic effectiveness of oral appliances may be comparable with CPAP because of the significant difference in adherence rates.³
• Blood Pressure Implications. This clinical question was not addressed in the 2006 AASM practice parameters. It can be evaluated in 2015 thanks to several randomized, controlled studies published in the last 10 years exploring the effects of oral appliance therapy on cardiovascular outcomes, specifically blood pressure measures. Oral appliances have a modest impact on reducing both diastolic and systolic blood pressure in adult patients with OSA. In fact, the meta-analysis shows that the impact that oral appliances have on blood pressure is of a similar magnitude to that of CPAP.
• QOL Measurements. Since the publication of the 2006 practice parameters, several high-quality clinical trials have established the benefits of oral appliance therapy in improving QOL measures in patients with OSA. The in-depth analysis shows that oral appliances are associated with significant improvements, leading the task force to conclude that oral appliance therapy is nearly equivalent to CPAP in its ability to improve QOL for patients.

Keeping Perspective

While the work of the task force was thorough and exhaustive, it’s important for both dentists and sleep physicians to remember that the recommendations in this guideline define principles of practice that should meet the needs of most patients in most situations. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances.

This guideline was developed to establish standards of care that can guide sleep physicians and dentists to the most successful patient outcomes. The document is ripe with high-quality evidence that underscores the relevant, vital role that oral appliance therapy can play in treating snoring and OSA. Both the AASM and AADSM anticipate that it will have a positive impact on professional behavior and

patient outcomes, while potentially contributing to reduced healthcare costs in the future.

Sheri G. Katz, DDS, is a past president of the AADSM. Leslie C. Dort, DDS, is secretary-treasurer of the AADSM. Visit www.aadsm.org to read the full guideline.

References

1. Ramar K, Dort LC, Katz SG, et al. Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for 2015. J Clin Sleep Med. 2015;11(7):773–827.

2. Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008;5:173-178.

3. Vanderveken OM, Dieltjens M, Wouters K, et al. Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing. Thorax. 2013;68(1):91–96.