Special Article 1, Issue 10.2
The Role of Temporary Appliances in Obstructive Sleep Apnea Treatmenthttp://dx.doi.org/10.15331/jdsm.7292
J. Michael Adame, DDS, D.ABDSM1; Michelle Cantwell, DMD, D.ABDSM2; Jennifer Q. Le, DMD, D.ABDSM, CPCC3; Sue Ellen Richardson, DDS, D.ABDSM 4; Charles Schumacher, DDS, D.ABDSM 5
1Adame Dental Sleep Medicine, 2Wellspan Pulmonary and Sleep Medicine, 3Wake Dental Sleep Dental Solutions, 4Houston Sleep Well; 5Desert Hills Dental Care
INTRODUCTIONA properly fitted, custom-fabricated oral appliance (OA) is an effective treatment for patients with snoring or obstructive sleep apnea (OSA).1 In addition to custom-fabricated appliances intended for long-term use, several temporary appliances are available.2 These appliances can be referred to in a variety of ways - as temporary, noncustom, interim, provisional, trial, and so forth. In this article, the term “temporary appliances” is used. This article provides guidance to qualified dentists for determining when a temporary appliance may be appropriate to use for a particular patient.
The literature addressing temporary appliances is limited. Some studies have compared the efficacy of temporary appliances with custom OAs with varying results and have explored whether temporary appliances can predict whether a patient will tolerate oral appliance therapy (OAT). Other trials have indicated that temporary appliances may lead to increased adverse effects and have lower compliance rates than custom-fabricated appliances.3 -5 One meta-analysis found that custom OAs are superior to temporary appliances in several ways, such as better efficacy in reducing apnea-hypopnea index, reduced daytime sleepiness, increased functionality, increased levels of adherence, and higher patient preference over temporary appliances.6 Other trials have indicated that temporary appliances are equivalent in efficacy to custom appliances.7,8 These studies have limitations, such as high dropout rates, but they indicate that temporary appliances over the short term (8 to 12 weeks) can elicit responses similar to those of custom appliances.
Additional research has focused on whether temporary appliances can play a role in helping to determine the therapeutic position of an appliance9-12 and predicting which patients are likely to respond or not respond to OAT.13-18
Dentists considering the use of a temporary appliance for a patient should be aware that these studies have limitations. None are long-term studies, and the literature yields few data about the use of temporary appliances selected and fit by patients themselves without the supervision of a qualified dentist per the American Academy of Dental Sleep Medicine (AADSM);19 therefore, the conclusions that can be drawn from the evidence to date are also limited. In addition, it is noted that much of the available literature is industry-supported.
DEFINITION OF A TEMPORARY APPLIANCEAccording to evidence and clinical expertise, the task force defined a temporary appliance as follows:
A temporary appliance is prescribed by a qualified dentist to treat OSA or snoring,20 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.
Temporary appliances as defined are unlikely to meet the definition of Healthcare Common Procedure Coding System code E0486 “oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, custom fabricated, includes fitting and adjustment.21” As stated in Medicare’s policy article for the treatment of OSA, prefabricated appliances (E0485) are produced without a specific patient in mind, whereas custom-fabricated OAs are fabricated for a particular patient;22 therefore, temporary appliances may fit the definition of prefabricated appliances (E0485). Additionally, Medicare classifies OAs as durable medical equipment, which by definition must be able to function for 3 to 5 years before needing replacement. Temporary appliances also do not meet the definition of an effective OA as defined by the AADSM. Custom appliances are fabricated based on impressions, models, or scans of the patient’s teeth that are used to construct the appliance. If it does not go through this process, it is not a custom-fabricated appliance. Custom-fabricated appliances are intended for long-term use; however, a qualified dentist may determine that such a device may be appropriate to use on a short-term basis by a specific patient.
POTENTIAL USES OF TEMPORARY APPLIANCESThe literature supporting the use of temporary appliances is limited; therefore, qualified dentists should understand that the evidence base for the use of temporary appliances is not strong; however, temporary appliances may be appropriate to use for a short period of time in some circumstances based on the clinical judgment of the qualified dentist.
Temporary appliances are typically lower in cost than custom-fabricated appliances23 and may be well accepted by patients in the short term. Additionally, temporary appliances may provide some improvement of symptoms during their initial use.23
Qualified dentists may want to consider a temporary appliance for use by patients who may not otherwise be able to immediately begin treatment with a custom device, such as first needing restorative dental work that would significantly change the fit of a custom appliance, other medical treatment, etc. If there is uncertainty about the patient’s likely response to or compliance with treatment, a temporary appliance may help the qualified dentist determine if treatment with a custom-fabricated appliance is feasible.
In determining whether a temporary appliance is appropriate for a specific patient, the qualified dentist should consider the following questions:
- What are the reasons for considering a temporary appliance? For example:
- Does the patient require major dental work immediately?
- Could a temporary appliance aid the qualified dentist in determining compliance or effectiveness?
- Are the stability and durability of the temporary appliance suitable for the patient?
- Will using the temporary appliance discourage or encourage the patient from using an OA?
- What adverse effects might the patient experience?
- How much will the temporary appliance cost the patient?
- If considering use of a temporary appliance to predict success with an OA, will the temporary appliance use the same mechanism as the OA that is most appropriate for the patient? Can the temporary appliance predict success if it works in a different way than the OA?
The task force developed an informed consent template specifically for use of a temporary appliance. Qualified dentists should obtain the patient’s informed consent to ensure understanding of the temporary nature of the device and its role in long-term treatment. Patients should be informed that the use of temporary appliances may be associated with greater incidence of adverse effects,23 and that the materials and durability of temporary appliances may result in a shorter recommended lifespan for the appliance. Using a temporary appliance longer than intended may place the patient at increased risk for adverse effects24 and long-term compliance with temporary appliances is unknown. Because temporary appliances are not indicated for long-term use, the qualified dentist must ensure that patients understand their successful treatment depends on returning to the dental office at the conclusion of their use of the temporary appliance to proceed with the next steps in treatment.
Collaboration With Other Providers
A patient may have other healthcare providers involved in their care, and the qualified dentist should communicate with these providers in the event a temporary appliance is warranted.
Qualified Dentist Must Oversee Treatment
The fitting and use of temporary appliances should be overseen by a qualified dentist. A careful review of the available literature shows that the use of temporary appliances in these studies has almost exclusively been under the supervision of a dentist with training and experience in dental sleep medicine. It should not be assumed that temporary appliances will have the same efficacy if purchased directly from the manufacturer by the patient. Contraindications may exist, such as morphologic features, periodontal disease, tooth decay, temporomandibular joint disease, complete or partial edentulousness, etc. Qualified dentists are best suited to identify any contraindications, evaluate the appropriateness of a temporary appliance for a particular patient, select and fit a temporary appliance that is appropriate for the patient, and manage any adverse effects that may occur.
Most of the available studies are based on dentist-delivered temporary appliances rather than on appliances sold directly to patients. Therefore, conclusions from studies based on dentist-delivered temporary appliances cannot be applied to temporary appliances delivered directly to the patient without the involvement of a qualified dentist. Patients who purchase a temporary appliance directly from a supplier may not be aware of their own oral and maxillofacial features and conditions that may contraindicate OAT and may not be able to manage the therapy on their own, including mitigating any adverse effects that may occur.
Lifespan of the Temporary Appliance
Temporary appliances have differing material stability and lifespans;6 therefore, the qualified dentist should refer to FDA guidance, warranty information from the device’s manufacturer, and their own expertise when selecting a temporary appliance. Most of the research cited in this article indicated a 6-month lifespan for a temporary appliance. Regardless of its ability to be customized, a temporary appliance should not be used as a long-term substitute for a properly fitted, custom-fabricated OA.
The qualified dentist should discuss the financial implications of treatment, as using a temporary appliance followed by a custom-fabricated appliance will be more costly than beginning treatment with the custom appliance. In some cases, the qualified dentist may propose using a custom-fabricated appliance on a temporary basis, followed by fabricating a second custom device, and this approach is also more costly for the patient.
The qualified dentist should provide the patient with clear information about the benefits of the proposed course of treatment but should also take the patient’s preference into account.
Using a Temporary Appliance to Predict Treatment Success
In some cases, it may be appropriate to consider using a temporary appliance to help determine if OAT is a feasible treatment option for a specific patient. In considering this use of a temporary appliance, the qualified dentist should consider whether the temporary appliance works in the same way as the OA that will be most appropriate for the patient. A temporary appliance may not be able to predict treatment success and compliance if the mechanisms are dissimilar to the custom-fabricated OA that will be used. The qualified dentist should also consider whether the patient’s experience with an ill-fitting or uncomfortable temporary appliance may discourage them from moving forward to a custom appliance.
CALL FOR FUTURE RESEARCH
Given the variability in current research findings related to temporary appliances, the task force encourages additional research on the role temporary appliances may play in dental sleep medicine. Research topics might include determining whether temporary appliances are suitable to predict treatment success or are appropriate for people with special conditions, such as pregnancy-related OSA.
The AADSM commissioned a task force of four experts with extensive knowledge of dental sleep medicine. None of these task force members declared conflicts of interest related to this topic. The task force reviewed literature about temporary appliances; it was not a systematic literature review. The task force took into consideration their own clinical experience, relevant literature on the topic, clinical practicality, and patient preference when developing this article.
Adame JM, Cantwell M, Le JQ, Richardson SE, Schumacher C. The role of temporary appliances in obstructive sleep apnea treatment. J Dent Sleep Med. 2023;10(2)
- Almeida FR, Lowe AA, Otsuka R, Fastlicht S, Farbood M, Tsuiki S. Long-term sequellae of oral appliance therapy in obstructive sleep apnea patients: Part 2. Study-model analysis. Am J Orthod Dentofacial Orthop. 2006;129(2):205–213.
- Temporary oral appliances for sleep apnea comparison guide (June 2019). Sleep Review Magazine. June 7, 2019. Retrieved October 17, 2022. https://sleepreviewmag.com/sleep-treatments/therapy-devices/oral-appliances/temporary-oral-appliances/
- Gagnadoux F, Nguyen XL, Le Vaillant M, et al. Comparison of titrable thermoplastic versus custom-made mandibular advancement device for the treatment of obstructive sleep apnoea. Respir Med. 2017;131:35-42.
- Vanderveken OM, Devolder A, Marklund M, et al. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea. Am J Crit Care Med. 2008;178(2):197-202.
- Sutherland K, Dalci O. Fake it till you custom-make it: a non-inferior thermoplastic mandibular advancement device? Thorax. 2019;74:629-630.
- Johal A , Agha B . Ready-made versus custom-made mandibular advancement appliances in obstructive sleep apnea: a systematic review and meta-analysis. J Sleep Res. 2018;27:e12660.
- Bosschieter PFN, Venema JAMU, Vonk PE, et al. Equal effect of a non-custom versus a custom mandibular advancement device in treatment of obstructive sleep apnea. J Clin Sleep Med. May 2022.
- Pépin JL, Raymond N, Lacaze O, et al. Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial. Thorax. 2019 Jul;74(7):667-674. doi: 10.1136/thoraxjnl-2018-212726. Epub 2019 May 3. PMID: 31053619.
- Kastoer C, Dieltjens M, Op de Beeck S, Braem MJ, Van de Heyning PH, Vanderveken OM. Remotely controlled mandibular positioning during drug induced sleep endoscopy toward mandibular advancement device therapy: feasibility and protocol. J Clin Sleep Med. 2018;14(8):1409–1413.
- Pételle B, Vincent G, Gagnadoux F, Rakotonanahary D, Meyer B, Fleury B. One-night mandibular advancement titration for obstructive sleep apnea syndrome: A pilot study. Am J Respir Crit Care Med. 2002;165(8):1150-1153.
- Kuna ST, Giarraputo PC, Stanton DC, Levin LM, Frantz D. Evaluation of an oral mandibular advancement titration appliance. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 May;101(5):593-603.
- Mosca EV, Bruehlmann S, Zouboules SM, et al. In-home mandibular repositioning during sleep using MATRx plus predicts outcome and efficacious positioning for oral appliance treatment of obstructive sleep apnea. J Clin Sleep Med. 2022 Mar 1;18(3):911-919.
- Remmers JE, Topor Z, Grosse J, et al. A feedback-controlled mandibular positioner identifies individuals with sleep apnea who will respond to oral appliance therapy. J Clin Sleep Med. 2017;13(7):871–880.
- Remmers J, Charkhandeh S, Grosse J, et al. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. Sleep. 2013 Oct 1;36(10):1517-25, 1525A.
- Kazemeini E, Op de Beeck S, Vroegop A, et al. A pilot study on comparison of subjective titration versus remotely controlled mandibular positioning during polysomnography and drug-induced sleep endoscopy, to determine the effective protrusive position for mandibular advancement device therapy. Sleep Breath. 2022 Jan 2022.
- Sutherland K, Ngiam J, Cistulli PA. Performance of remotely controlled mandibular protrusion sleep studies for prediction of oral appliance treatment response. J Clin Sleep Med. 2017;13(3):411-417.
- Levendowski DJ, Morgan T, Westbrook P. Initial evaluation of a titration appliance for temporary treatment of obstructive sleep apnea. J Sleep Disord Ther. 2012;1(1):101.
- Soh L, Han HJ, Yue Y, Tay JY, Hao Y, Toh ST. Evaluation of prefabricated adjustable thermoplastic mandibular advancement devices (PAT-MADs) for obstructive sleep apnea: an Asian experience. Sleep Med. 2020;75:96-102.
- Levine M, Bennett K, Cantwell M, Postol K, Schwartz D. Dental sleep medicine standards for screening, treating, and managing adults with sleep-related breathing disorders. J Dent Sleep Med. 2018;5(3):61-68.
- Ramar K, Dort LC, Katz SG, et al. Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for 2015. J Dent Sleep Med. 2015;2(3):71–125.
- Oral appliances for obstructive sleep apnea. Centers for Medicare and Medicaid Services. Retrieved October 17, 2022. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33611&ContrId=389
- Welcome to the MCD search. Centers for Medicare and Medicaid Services. Retrieved October 17, 2022. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52512&ver=29&
- Friedman M, Hamilton C, Samuelson CG, et al. Compliance and efficacy of titratable thermoplastic versus custom mandibular advancement devices. Otolaryngol Head Neck Surg. 2012;147:379–86.
- Tsuda H, Almeida FR, Masumi S, Lowe AA. Side effects of boil and bite type oral appliance therapy in sleep apnea patients. Sleep Breath. 2010;14:227–232.
SUBMISSION AND CORRESPONDENCE INFORMATION
Submitted in final revised form October 3, 2021.
Address correspondence to: J. Michael Adame, DDS, D.ABDSM; Email: firstname.lastname@example.org
The authors report no conflicts of interest.