Custom Oral Appliances vs OTC Boil & Bite Appliances for Sleep Apnea: The Pros and Cons

By Jordan Stern, MD

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Sleep apnea is a serious sleep disorder that can significantly impact an individual's quality of life, overall health, well-being, and life expectancy. While various treatment options exist, oral appliance therapy has emerged as a proven first line treatment compared to traditional CPAP (Continuous Positive Airway Pressure) machines. However, not all oral appliances are created equal. This article explores the critical differences between custom-made and over-the-counter (OTC) oral appliances, highlighting why custom solutions offer superior benefits for patients suffering from sleep apnea.

Understanding Sleep Apnea and Oral Appliance Therapy

Sleep apnea is characterized by repeated interruptions in breathing during sleep, leading to potential health risks such as cardiovascular problems, daytime fatigue, and cognitive impairments. Oral appliance therapy has gained significant traction as a non-invasive treatment option, particularly for patients with mild to moderate obstructive sleep apnea (OSA) and those who do not want to use CPAP, or are intolerant to CPAP therapy.

The Limitations of Over-the-Counter Appliances

Over-the-counter oral appliances, often referred to as "boil and bite" devices, may seem like an attractive, cost-effective solution. These generic devices are typically made of thermoplastic materials that can be softened in hot water and then molded to the user's teeth. While they may provide some initial relief, they come with several significant limitations: 

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1. No Medical Oversight: First and foremost, buying a boil and bite appliance online is simply buying a device without any medical oversight or assessment. You haven’t had the benefit of a medical consultation with a medical sleep specialist. Such a consultation includes reviewing the sleep history, the medical history, the social and family history; and an evaluation of the upper airway whether by telemedicine or in person. The sleep specialist will likely order and review a home sleep test, and discuss in depth the medical conditions associated with sleep apnea. Finally, the follow up from the medical team is critical in determining if the oral appliance is effective (by repeating a sleep test while sleeping with the oral appliance), and if it isn’t; then discussing alternative treatments to help prevent the serious consequences of untreated sleep apnea. Severe untreated sleep apnea is associated with a 50% mortality rate over 15 years.
2. Poor Fit and Effectiveness: Unlike custom-made appliances, OTC devices cannot account for the unique anatomical variations of an individual's mouth, jaw structure, and bite alignment. This results in suboptimal positioning and reduced effectiveness in managing sleep apnea.
3. Limited Customization: Boil and bite appliances offer minimal adjustability, preventing precise positioning of the jaw to optimize airway opening. Custom appliances, in contrast, can be precisely adjusted to each patient's specific anatomical needs.
4. Reduced Comfort: The lack of precise fitting often leads to discomfort, which can significantly impact patient compliance. Patients are less likely to consistently use a device that causes mouth irritation, excessive salivation, or jaw pain.
5. Not Covered By Insurance: Medical insurance doesn’t cover OTC oral appliances. 

Research-Backed Benefits of Custom Oral Appliances

The American Academy of Dental Sleep Medicine (AADSM) provides compelling evidence supporting the superiority of custom oral appliances. Their research conclusively demonstrates that:

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• Custom-made appliances approved for OSA treatment are significantly more effective in reducing the Apnea-Hypopnea Index (AHI) compared to boil and bite devices.
• Comfort is a critical factor in treatment compliance, and custom appliances consistently outperform OTC options in patient comfort.
• Even in short-term evaluations, the comfort difference between custom and non-custom devices is notably significant.

Key Advantages of Custom Oral Appliance Therapy

1. Precision Fitting

Custom oral appliances are created using detailed impressions of a patient's teeth and jaw, ensuring:

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• Proper  alignment
• Optimal jaw positioning
• Minimal discomfort
• Maximum effectiveness in opening the airway

2. Professional Oversight

Unlike OTC solutions, custom oral appliance therapy involves:

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• Professional assessment by sleep specialists and sleep dentists
• Ongoing monitoring of treatment effectiveness
• Adjustments based on individual patient response
• Comprehensive follow-up to address potential side effects

3. Personalized Treatment

Custom appliances offer:

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• Tailored design to individual anatomical structures
• Precise titration (adjustment) capabilities
• Ability to address specific patient needs
• Higher potential for long-term successful treatment

4. Health Monitoring

Professional custom appliance therapy includes:

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• Regular sleep testing to confirm treatment efficacy
• Dental health assessments
• Monitoring for potential occlusal changes
• Comprehensive patient care approach

BlueSleep: Setting the Gold Standard in Oral Appliance Therapy

BlueSleep exemplifies best practices in oral appliance therapy by strictly adhering to the American Academy of Sleep Medicine (AASM) guidelines by:

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• Prescribing oral appliances, rather than no therapy, for adult patients who request treatment of primary snoring (without obstructive sleep apnea).
• Using a custom, titratable appliance over non-custom oral devices.
• Considering 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.
• Providing 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. 
• Conducting follow-up sleep testing to improve or confirm treatment efficacy, rather than conduct follow-up without sleep testing, for patients fitted with oral appliances.

Cost Considerations

While custom oral appliances have a higher upfront cost compared to OTC solutions, they offer:

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• Higher treatment success rates
• Reduced risk of complications
• Potential savings on future healthcare interventions

Patients should seek a Sleep Specialist that’s in-network with major health insurers to reduce the cost of the diagnosis and treatment of sleep apnea.

Conclusion

For individuals struggling with sleep apnea, investing in a custom oral appliance is not just a treatment choice—it's a commitment to comprehensive health management. The precision, comfort, and professional oversight provided by custom solutions far outweigh the initial savings of over-the-counter alternatives.

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As research continues to validate the effectiveness of custom oral appliance therapy, patients are increasingly recognizing the importance of personalized, professional treatment approaches. By choosing a custom oral appliance, individuals can significantly improve their sleep quality, overall health, and quality of life.