AM Aligner for Sleep Apnea

Overseen By Isabel Moreno Hay, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Isabel Moreno Hay

Disqualifiers: Orthognathic surgery, Cross bite, Bruxism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to prevent teeth from shifting in individuals using a Mandibular Advancement Device (MAD) for sleep apnea. It compares the effectiveness of a morning aligner (AM Aligner) with daily jaw exercises in maintaining teeth alignment. The goal is to determine which method better prevents changes in how teeth fit together. Individuals with sleep apnea who use a MAD and have most of their back teeth intact may qualify for this study. As an unphased trial, it offers participants the chance to contribute to research that could enhance dental health for MAD users.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these methods are safe for preventing occlusal changes?

Research has shown that both the AM Aligner and jaw exercises are well-tolerated by people using a Mandibular Advancement Device (MAD) for sleep apnea. The AM Aligner realigns the jaw after device use, preventing changes in bite, and is designed for daily use with a comfortable fit.

Studies indicate that jaw exercises have a limited effect on jaw pain and function, suggesting they are safe and easy to perform. These exercises include simple movements like moving the jaw side-to-side and gentle clenching. Both methods aim to maintain a normal bite without causing discomfort.

Overall, both approaches are safe and considered standard care for managing potential bite changes in MAD users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for sleep apnea because they offer innovative methods to maintain jaw alignment and minimize occlusal changes after using a Mandibular Advancement Device (MAD). The AM Aligner is a thermoplastic device that users bite into for a few minutes each morning, helping reposition the jaw and maintain its original position. This approach is noteworthy because it directly targets the occlusal changes associated with MAD therapy, which is not addressed by conventional treatments. Additionally, the daily jaw exercises provide a non-invasive, physical therapy-like option that encourages natural jaw movement and strength, potentially reducing the need for more invasive interventions. These strategies offer fresh, practical additions to the standard care options, which typically focus on devices like CPAP machines or lifestyle changes.

What evidence suggests that this trial's treatments could be effective for preventing occlusal changes in sleep apnea patients?

Research shows that a Mandibular Advancement Device (MAD) can effectively reduce snoring and breathing problems in people with sleep apnea. However, it might alter how teeth fit together. In this trial, participants in one group will use the AM Aligner each morning to return the jaw to its normal position and maintain the original bite, addressing any temporary changes caused by the MAD. In another group, participants will perform jaw exercises, which studies suggest can strengthen the bite and improve how the teeth meet. Both methods in this trial aim to keep the bite stable and prevent long-term changes during MAD therapy. ^{4 6 7 8 9}

Who Is on the Research Team?

Isable Moreno Hay, MS, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals using a Mandibular Advancement Device (MAD) to treat sleep-related breathing disorders like obstructive sleep apnea. Participants should be experiencing or at risk of bite changes due to MAD use.

Inclusion Criteria

I have all my back teeth except for one premolar removed for braces.

I am an adult with a sleep breathing disorder and have been prescribed a device to help my jaw position.

Exclusion Criteria

I have major tooth decay or gum disease.

Existing open bite or implant supported restorations

Severe bruxism

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to use either an interocclusal aligner or perform daily jaw exercises to prevent occlusal changes during MAD therapy

12 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for occlusal changes and other dental outcomes after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AM Aligner
• Exercise

Trial Overview The study compares two standard-of-care methods: wearing an interocclusal aligner each morning after MAD removal, and performing daily jaw exercises. The goal is to prevent teeth fit alterations from MAD therapy over a 3-month period with evaluations and surveys.

How Is the Trial Designed?

Group I: Interocclusal Aligner Active Control 1 Intervention

Arm 1 (Interocclusal Aligner Group): "Morning Interocclusal Aligner to Maintain Occlusion" Participants in this arm will use a prefabricated thermoplastic device called the AM Aligner each morning immediately after removing their Mandibular Advancement Device (MAD). The aligner will be warmed and then gently bitten into for 2-5 minutes to help reposition the mandible and maintain the original occlusion. This approach is a standard-of-care method aimed at minimizing occlusal changes associated with MAD therapy.

Group II: Daily Jaw Exercises Active Control 1 Intervention

Participants in this arm will be instructed to perform a standardized set of jaw exercises each morning after removing their MAD. The exercises include side-to-side jaw movements, backward pressure (such as the "thinker's pose"), and gentle simulated clenching.

Who Is Running the Clinical Trial?

Isabel Moreno Hay

Lead Sponsor

Trials

2

Recruited

50+

American Academy of Orofacial Pain

Collaborator

Citations

1. glidewelldental.com glidewelldental.com/company/blog/use-the-am-aligner-to-correct-temporary-morning-bite-change

AM Aligner Corrects Temporary Morning Bite Change The AM Aligner creates a centric occlusion guide assuring the doctor and patient that the “bite” is back to normal in the morning and fulfills all of the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6346846/

Oral Appliance Effectiveness and Patient Satisfaction with ... It follows from the presented results that obstructive sleep apnea syndrome represents a complex problem which cannot be reduced to a handful of parameters.

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.3460

Oral Appliance Treatment for Obstructive Sleep Apnea There is now a large body of research that demonstrates efficacy of OAm in terms of reducing snoring and obstructive breathing events as well as showing ...

4. mdpi.com mdpi.com/2673-8937/5/4/49

Efficacy of Mandibular Advancement Devices in the ... Outcomes: Treatment of OSA to improve quality of life and reduce the risk of cardiovascular complications, apnea-hypopnea index (AHI), oxygen saturation, and ...

5. researchgate.net researchgate.net/publication/389593155_A_systematic_review_of_mandibular_advancement_using_clear_aligners_in_patients_with_sleep_apnea

A systematic review of mandibular advancement using ... The use of MA devices (MADs) in conjunction with orthodontic aligners was successful in managing snoring and mild sleep apnea and allowed the ...

6. glidewelldirect.com glidewelldirect.com/products/am-aligner

AM Aligner The AM Aligner takes a registration of the patient's normal bite before mandibular advancement device therapy. It is used each morning after treatment.

7. glidewelldental.com glidewelldental.com/solutions/sleep-dentistry/mandibular-advancement-devices/tap-3-tl

How to Stop Snoring? TAP® 3 TL The TAP 3 TL appliance holds the lower jaw in a forward position during sleep to reduce snoring and improve breathing.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8949347/

Dental and Skeletal Side Effects of Oral Appliances Used for ... Interventions: studies that treated obstructive sleep apnea and/or snoring patients with an oral appliance that protruded the mandible forward;.

9. sleeplay.com sleeplay.com/products/am-aligner-jaw-realignment?srsltid=AfmBOopDeYVw8eZugiXkpzLm-rlDdnksLZe96xHx8hJpo-Q_-PCtIq3J

AM Aligner Post-Sleep Apnea Jaw Realignment AM Aligner solves jaw alignment issues post-sleep apnea therapy. Prevents bite changes with a comfortable fit for easy, daily use.