The AGGA Device Saga Continues to Heat Up

Plus: Using Teledentistry to Grow Your Practice

Good morning. This is More Than Teeth. The newsletter that helps dental sleep professionals get 1% better every week.

In this week’s issue:

  • The AGGA Device Saga Continues to Heat Up

  • SNOO is Granted FDA Approval

  • Case Report: Central Sleep Apnea and Sleep Appliances

  • Teledentistry In DSM

  • 85 Cent Sweet Tooth Fix 🍦

  • National Indicator Report For Obstructive Sleep Apnea

This is a 7-minute read today. Let’s dive inπŸ‘‡

Clinical Corner

πŸ₯ΌUse the clinical corner as your secret weapon to impress your colleagues and patients!

A joint investigation by KHN and CBS News into the Anterior Growth Guidance Appliance (AGGA), a dental device alleged to have caused significant harm to patients, has prompted the FDA to investigate. The AGGA has been fitted on over 10,000 dental patients, with no records of it being registered with the FDA. The device's inventor, Dr. Steve Galella, claims it doesn't fall under FDA jurisdiction, but former FDA official Cara Tenenbaum argues the lack of registration is "incredibly problematic."

The Las Vegas Institute, which previously trained dentists to use the AGGA, now teaches them to use a similar device called the Anterior Remodeling Appliance (ARA). Both appliances have been criticized by dental specialists for allegedly causing severe complications.

The investigation into AGGA and similar devices may lead to increased scrutiny, regulation, and potential compliance actions in the dental sleep industry.

Navigate the investigation's impact on the dental sleep industry, follow these steps:

  1. Stay informed: Keep up-to-date with industry developments and potential changes in regulations, aka β€œfollow More Than Teeth.”

  2. Prioritize patient safety: Ensure your practice adheres to all safety guidelines and utilizes FDA-approved devices.

  3. Address concerns: Be proactive in handling any patient concerns or potential complications.

  4. Monitor industry trends: Keep an eye on similar devices and any compliance actions that may arise.


As dental sleep professionals we have limited options to help new borns aside from patient education and tongue tie releases. Luckily, the FDA apporoved an additional option by granting De Novo approval to Happiest Baby's SNOO Smart Sleeper, marking a major milestone for infant safety. This is the first time the FDA has approved a product designed to keep sleeping babies safely positioned on their backs, reducing the risk of SIDS.

😴 Why does it matter? Sudden Unexpected Infant Death (SUID) remains the leading cause of death for healthy, full-term infants in their first year of life. With 3,500 American babies dying in their sleep annually, the need for a safe sleep solution is urgent.

πŸ›Œ Enter SNOO: This innovative smart sleeper aims to minimize the risk of SUID by keeping babies securely on their backs during sleep. In a study of 1,012 infants, SNOO reduced unsafe stomach sleeping by a whopping 91.5%.

🎯 Targeting babies under 6 months old or those who can't consistently roll from stomach to back, SNOO could be a game-changer in infant sleep safety. While it hasn't directly shown a reduction in SIDS/SUID incidence, the potential is enormous.

A recent case report revealed that central sleep apnea (CSA) events emerging after using a mandibular advancement device (MAD) can resolve spontaneously in patients with moderate obstructive sleep apnea (OSA) who refuse positive airway pressure (PAP) treatment.

πŸ“š The Case: A 69-year-old male with a history of diabetes, hypertension, coronary artery disease, and atrial fibrillation was diagnosed with moderate OSA. He refused PAP therapy and opted for a MAD instead. After three months, a follow-up sleep study showed no significant change in his apnea-hypopnea index (AHI) but revealed a 49% central event rate. The patient refused PAP therapy again but continued using the MAD. One year later, his central events had completely resolved.

πŸš€ Key Takeaways:

  1. MAD-emergent CSA events can resolve spontaneously over time, similar to PAP-emergent CSA events.

  2. Close clinical and sleep study follow-ups are essential after optimal MAD advancement.

  3. Atrial fibrillation may be associated with MAD-emergent CSA development.

Are you loving More Than Teeth?

Don't keep it to yourself!

Share the wealth and refer a friend to join our community of dental sleep professionals. By spreading the word, you'll help others stay informed, improve their practice, and ultimately save more lives.

Business of Sleep

πŸ“ˆBetter businesses = more lives saved!

Dental sleep medicine is on the rise, and teledentistry is playing a significant role in enhancing its practice. Let's take a look at how teledentistry can complement your dental sleep medicine workflow, expanding your reach and improving patient care.

1️⃣ Virtual Screenings: Teledentistry makes initial patient screenings for obstructive sleep apnea (OSA) a breeze. Review the patient's medical history and sleep surveys, like the Epworth Sleepiness Scale and the STOP-BANG questionnaire, virtually. If the patient is at risk for OSA, refer them to a sleep medicine physician for further evaluation.

2️⃣ Medical-Dental Collaboration: Forge strong working relationships with local sleep medicine physicians for seamless patient evaluation and diagnosis of sleep-related breathing disorders. Teledentistry enables virtual introductions, co-management huddles, and collaborative treatment planning to strengthen these relationships and improve patient care.

3️⃣ Virtual Post-Sleep Study Consultation: Use teledentistry for virtual consultations with referring sleep physicians to discuss your patient's medical history, survey scores, airway radiographs, and treatment options like continuous positive airway pressure (CPAP) or mandibular advancement devices (MADs). After the virtual consultation, schedule an in-office visit to perform a comprehensive oral evaluation and create the oral appliance.

Remember, teledentistry isn't a substitute for in-office visits, but it's a valuable tool for complementing and growing your dental sleep medicine practice. Embrace the future of dental sleep medicine with teledentistry! 🌟

Something Sweet

🍭Stuff so sweet you might get a cavity..

We all deserve a treat for getting through a long winter!

Miscellaneous

πŸ˜…P.S. … I forgot something

American Academy of Sleep Medicine and the Sleep Research Society, has released a national indicator report for obstructive sleep apnea that provides an in-depth analysis of symptoms, risk factors, prevalence and burden.

What did you think of today's newsletter?

Login or Subscribe to participate in polls.

Reply

or to participate.