Nightguards are commonly prescribed by dentists for clenching and grinding problems. Until recently, most nighttime appliances were fabricated solely for the upper arch, in a retruded jaw position, with a flat plane of occlusion and cuspid guidance. Recently, the airVata™ 3-in-1 oral device (New York, NY) was introduced to enhance the management of both daytime and nighttime complaints. The device recently received FDA approval as a Class 2 medical device for snoring and Obstructive Sleep Apnea.
The following are common complaints that are encountered daily by dental teams.
Daytime complaints include tinnitus, ear fullness, jaw and neck pain, headache, ear pain, and fractured restorations secondary to clenching.
Nighttime complaints range from snoring, sleep apnea, bruxism, and disturbed sleep leading to a worn out feeling all day.
Other complaints relate to mood, neurocognitive impairment, and a weakened immune system. Each complaint is related to a medical diagnosis, and thus the diagnosis of sleep disordered breathing is made in conjunction with a board-certified sleep physician.
The airVata™ is a novel daytime/nighttime approach to pain, clenching/bruxism, and sleep disordered breathing. It has upper and lower components, and a patent-pending side connector (Fig.1). The lower component (Fig. 2) can be worn during the day to cognitively and behaviorally train the patient to keep lips together and teeth apart. Orthopedically, the lower device is positioned to decompress the temporomandibular joints and to lessen clicking, popping and locking, and to diminish joint pain. By lengthening the masticatory muscles, the device also manages myofascial pain. A phonetic bite is often used to 3-dimensionally reposition the jaw into a concentric or Gelb 4/7 jaw position, with an open airway, and no clicking or joint compression. The esthetic benefit is a considered a bonus.
Fig. 1
Fig. 2
Wearing upper and lower elements together at night prevents the mandible from dropping back, reducing clicking, popping, and locking on awakening. The side connectors may be necessary to avoid retrusion or lateral displacement of the mandible (Fig. 1). By preventing the jaw from dropping back, the tongue is held forward, thereby averting the collapse of the airway. Airway collapse deterrence is an essential component of the management of snoring and Obstructive Sleep Apnea. airVata™ allows 1-2mm of additional airway opening by protruding the mandible with additional trays with more advancement.
Opening the airway may also help to reduce sympathetic activity and bruxism. Reducing heavy contact on the distal molars with airVata™ can also be beneficial as the jaws are a class 3 lever system.
Case Study
A 42-year-old male presented with the following chief concerns:
- Snoring
- History of sinus infections
- Excessive daytime sleepiness
- History of clenching and grinding
- Left temporal pain
History of Present Illness:
Patient was aware of snoring. A nightguard made by a previous dentist worsened his symptoms after insertion. Patient reported clenching and soreness in the left temporal area upon waking in the morning.
Clinical Examination:
On muscle palpation, there was tenderness of the left temporalis muscle. There was significant wear on maxillary and mandibular incisors, and several bonded composites had “popped off” over the last several years. Interincisal opening was 40mm. Lateral excursions were within normal limits.
Extraoral exam: venous pooling under the eyes, obtuse chin-throat angle.
Intraoral exam: severely worn dentition, both anterior and posterior teeth, and collapsed VDO (Vertical Dimension of Occlusion) Mallampati Class III.
Contributing Factors:
1. Enlarged tongue
2. High vaulted, narrow palate
3. Weight gain
4. Clenching
Sequential Treatment Plan:
A Board-Certified Sleep Physician dispensed the Watchpat HSAT (Home Sleep Apnea Test). The Watchpat is an FDA-cleared, portable home sleep apnea test and diagnostic device that uses PAT (Peripheral Arterial Tone) to ensure the accurate detection of sleep apnea. It measures up to 7 channels (PAT signal, heart rate, oximetry, actigraphy, body position, snoring, and chest motion). The patient completed the Initial Sleep Test, which was read, with diagnosis and recommendations given by the Sleep Physician (Tables 1-5).
Table 1
Table 2
Table 3
Table 4
Table 5
Sleep Physician diagnosed patient with Moderate Sleep Apnea
AHI = 15.9 RDI=18.9 ODI=14.5
63 desats between 4 and 9 %
The AHI (Apnea Hypopnea Index) is the Sleep Physician’s measure to diagnose the patient. AHI of 5-15, is considered Mild Sleep Apnea. AHI of 15-30, is considered Moderate Sleep Apnea AHI of >30, is considered Severe Sleep Apnea.
Sleep Specialist Recommendations:
a. Oral Appliance evaluation with a sleep dentist followed by a trial of Oral Appliance Therapy (airVata-Mandibular Advancement Device)
b. Close follow-up to ensure compliance and efficacy
c. Weight management and regular exercise
d. Avoidance of alcohol, sedatives and other CNS depressants (products that may worsen sleep apnea and disrupt normal sleep architecture)
e. Review of Sleep Hygiene to assess factors that may improve sleep quality
f. Advice restricting driving or operating machinery if sleepy
g. Advise about consequences of untreated sleep apnea
airVata Treatment Protocol
The patient returned to the Sleep Dentist for IOS (Intra-Oral Scan) in order to fabricate the airVata appliance. A week later, the appliance was inserted, and full instructions given, including placement and removal demonstrations. The AM Aligner (Morning Repositioner) was also delivered to ensure no bite changes occurred.
The appliance occlusion was verified. Even, bilateral contact, from 1st molar to 1st molar, was achieved. The patient reported that the appliance was comfortable (Figs. 3-5).
Fig. 3
Fig. 4
Fig. 5
Follow-up protocol:
1. 24-hour follow-up via zoom – patient reported feeling more refreshed
2. 48-hour follow-up via zoom – patient reported feeling comfortable, with no soreness, and his wife reported a significant decrease in snoring
3. 1-week follow-up at the office – patient reported feeling more refreshed, with no jaw pain and decreased snoring. The occlusion was checked, and the appliance adjusted on the lower left. Patient reported utilizing AM aligner every morning and stated that the appliance was very comfortable
4. 2-week follow-up at the office – the occlusion was checked, and the patient was advised to utilize the AM aligner to prevent the bite from changing and the teeth from shifting. The patient indicated a marked improvement in sleep and said that his wife reported his snoring is at a minimum
5. With improvement of the chief concerns/subjective findings, the patient was given a Follow-up/Efficacy test after 5 months
6. Yearly follow-up to evaluate the airVata™ appliance fit was recommended
Follow-up/Efficacy Sleep Test wearing airVata (Tables 6-9).
Table 6
Table 7
Table 8
Table 9
Case Summary at 5-month post insertion sleep test with airVata™ sleep appliance (Table 1).
1. pAHI 3% decrease of 59%
2. pAHI 4% decrease of 62%
3. ODI 4% decrease of 61%
4. Loud Snoring decrease of 92%
Table 10
| Initial (pre-treatment) | Post-treatment efficacy (5 months) | |
| TST | 4 Hours 33 Minutes | 6 Hours 8 Minutes |
| RDI | 18.9 | 15.1 |
| pAHI 3% | 15.9 | 6.5 |
| pAHI 4% | 9.7 | 3.6 |
| ODI 4% | 7.8 | 3.0 |
| Nadir O2 | 87 | 88 |
| Snoring Decibels Mean | 43db | 40db |
| Loud Snoring | 79.5 Minutes | 6.3 Minutes |
There has been little advance in nightguard techniques and technologies over the past 50 years. New research, CBCT diagnostics, and home sleep testing can offer an enhanced day/night system. A digital workflow, including scanning and 3D printing, provides more precision. airVata™ is a novel day/night system addresses both daytime and nighttime symptoms, and is also recommended for TMD (temporomandibular disorders), snoring, and mild and Moderate OSA. 
Oral Health welcomes this original article.
About the Author
Dr. Michael Gelb is an inventor, lecturer, NYU professor and author, GASP: Airway Health – The Hidden Path to Wellness. His has pioneered TMJ, airway centered disorders, sleep apnea, sleep disorders, and chronic headache treatments with Airway Centric Dentistry. He is co-founder: Foundation for Airway Health, AAPMD, and The Gelb Institute.
Dr. Layne Martin followed a distinguished military career with an Orthodontic and Craniofacial Orthopedic Fellowship and Professorship at CTOR. A Diplomate, American Board of Sleep Medicine, he is co-creator of custom airVata, the revolutionary nightguard for airway and wellness.
