Temporary oral appliances (also known as transitional, interim, or trial appliances) facilitate immediate therapy for obstructive sleep apnea (OSA) versus the longer waits for custom oral appliances for OSA.
According to an American Academy of Dental Sleep Medicine task force, they are defined as: “A temporary appliance is prescribed by a qualified dentist to treat OSA or snoring, is generally prefabricated or has a prefabricated shell that can be customized to fit an individual patient and is able to be calibrated. Temporary appliances are indicated for short-term use as a transition to a properly fitted, custom-fabricated OA. Temporary appliances are not indicated to be used as a long-term substitute for a properly fitted, custom-fabricated OA. As indicated by manufacturer warranty and FDA material safety data, temporary appliances are suitable for 3 to 6 months of continued use on average or up to 12 months in situations that require interim use for restorative care (or needs), assessing tolerance, or financial reasons. Over-the-counter appliances do not meet this definition.”
This temporary oral appliances guide compares features such as FDA status, how it works, time to fit, fitting description, adjustment description, materials, efficacy data, predictive value data, warranty, estimated useful life, payor reimbursement status, research supporting the appliance, and more.
The temporary oral appliances compared are:
Advanced Brain Monitoring Inc Apnea Guard
Airway Management Inc myTAP
Glidewell Laboratories Silent Nite sl
| Company | Advanced Brain Monitoring Inc | Airway Management Inc | Glidewell Laboratories |
| Appliance | Apnea Guard | myTAP | Silent Nite sl |
| FDA Status | FDA cleared in 2011 (Class II Device) | FDA cleared to treat snoring and mild to moderate OSA (Class II Device) | FDA 510(k) cleared June 25, 1997 for snoring; FDA 510(k) cleared June 14, 2018 for snoring and mild to moderate OSA |
| How It Works | The Apnea Guard combines a full range of mandibular advancement with one of three vertical dimension settings to define the optimal jaw forward position for the treatment of obstructive sleep apnea. The Apnea Guard can serve as a titration appliance with the settings transferred to a custom appliance or used as a trial/temporary appliance for up to 30 days. | The myTAP works by advancing and stabilizing the lower jaw at a single point midline so the soft tissues of the throat and tongue do not collapse into the airway. The myTAP comes with an AM Aligner to prevent tooth and jaw movement and a Mouth Shield to promote nasal breathing. | Mandibular advancement appliance. Connectors on right and left buccal side will pull the mandible in protrusion to open up the airway. 6 adjustable settings. AM Aligner offered with every Silent Nite. |
| Time to Fit | 6-12 minutes (depending on experience) | 10-15 minutes (with an AM Aligner) | <15 minutes |
| Maximum Protrusion (mm) | 18 | 21 | 6 |
| Maximum Retrusion (mm) | 7 (forward adjustment from midline for class 1 (retrognathic) bites) | -5 | -1 |
| Adjustment Increment (mm) | 1 | 1/3 | 1 |
| Materials | 5.5 grams of catalyst and base retention material are required to fit the top or bottom trays of the low, medium, or high Apnea Guard. | The inner tray is a patented ThermAcryl material that can be reformed and remolded as many times as necessary. | Trays are standard soft inner liner and hard outer layer. May also come in hard/hard based on undercuts. |
| Predictive Value Data | Identifying responders to custom oral appliance: Odds 3.4 p<0.02. Identifying those who achieve a custom OA AHI < 10: Odds 4.0 p-0.002. (Data presented at AADSM 2019) | Study compared myTAP to custom SomnoMed Flex: results showed that myTAP identifies responders to OA treatment. Also, myTAP significantly reduced AHI in severe OSA cases. (doi: 10.1155/2021/8811700) | Silent Nite may be used provisionally per Glidewell’s provisional mandibular advancement device protocol. But it does not need to be only a “temporary” appliance. It’s a definitive solution for snoring and mild to moderate obstructive sleep apnea. |
| Warranty (days) | 30 | 30 | 180 |
| Estimated Useful Life (days) | 30 | 90 | Varies based on factors such as clenching, bruxing, and maintenance |
| Payor Reimbursement Status | Providers have been consistently reimbursed using E0485. | A limited volume of clients have seen varying reimbursements under EO485. This is new and developing information. | No payor reimbursement data provided but marketer offers a guarantee that if it doesn’t stop snoring, the user can get their money back. |
| Research Supporting the Appliance | Levendowski DJ, Sall E, Morgan T, et al. Validation of a novel trial oral appliance protocol versus a conventional custom oral appliance protocol for the treatment of obstructive sleep apnea. J Dent Sleep Med. 2021;8(2). | Bosschieter PFN, Uniken Venema JAM, Vonk PE, et al. Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea. J Clin Sleep Med. 2022 Sep 1;18(9):2155-65. | Borrie F, Keightley A, Blacker S, Serrant P. Mandibular advancement appliances for treating sleep apnoea/hypopnoea syndrome. Evid Based Dent. 2013 Mar;14(1):27-8 |
Information for this guide based on data submitted by temporary oral appliance marketers. Sleep Review strives for accuracy in all data but cannot be held responsible for claims made by marketers. All temporary oral appliance marketers get one listing at no charge. Advertisers are offered multiple listings. All options may not be included. Email editor[at]sleepreviewmag.com to be considered for the next update.
