The recent article by Bosschieter et al1 compared a custom fabricated appliance to a noncustom, temporary appliance and found that, over a 12-week period, the 2 devices were statistically similar in efficacy. While this article provides evidence of noncustom appliances as an interim treatment, dentists must still provide a custom appliance in a timely manner and adhere to the American Academy of Sleep Medicine (AASM) clinical practice guideline that suggests custom, titratable appliances be used over noncustom appliances.2
During the study, the fitting and treatment of both the custom and noncustom appliances were overseen by a dentist. In practice, a qualified dentist selects an appropriate custom appliance based on craniofacial structures; dental, temporomandibular joint, and periodontal status; and patient cognitive ability, manual dexterity, visual acuity, and nasal patency.3 Many patients may be unaware of their own contraindications to treatment and studies report side effects with noncustom appliances. In a direct-to-consumer world, we have concerns that irreversible insult to the temporomandibular joint and surrounding oral structures may occur4 and caution both providers and their patients from conflating a noncustom, temporary device with an over-the-counter oral appliance.
Also, although the article did not show any significant differences in reported side effects, this may be attributable to the very small sample size. It is noted that both appliances were initially protruded to 50% and then titrated to maximum comfortable protrusion.1 In the short and long term, this approach could lead to an increased occurrence of side effects.5 This study suggests promise for the use of noncustom fabricated appliances as a trial device, but more long-term research on side effects and patient compliance must be conducted, especially given the conflicting research in this area.6–9
In practice, when noncustom appliances are used, they should be utilized in the short term only and not as a replacement for custom-fabricated, long-term oral appliances. A qualified dentist should always supervise oral appliance therapy, as they are trained to minimize side effects as well as manage side effects that may arise. If a noncustom fabricated appliance is provided, the qualified dentist should refer to Food and Drug Administration and manufacturer guidelines on how long such appliances can last and subsequently provide the patient with a long-term, custom-fabricated appliance.
DISCLOSURE STATEMENT
All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. Dr. Schwartz declares investments in Prosomnus Sleep and honorarium for presentation at Prosomnus-sponsored educational event. Dr. Postol declares compensation for his participation in a research study that is receiving funding from SomnoMed. Dr. Levine declares honorarium for presentation at Prosomnus-sponsored educational event. Dr. Cantwell declares no conflicts of interest.
Citation:Levine M, Cantwell M, Postol K, Schwartz D. Comparison of a noncustom vs custom mandibular advancement device to treat obstructive sleep apnea. J Clin Sleep Med. 2023;19(1):205–206.
REFERENCES
- 1. 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. ; 18 ( 9 ): 2155 – 2165 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2. 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 Clin Sleep Med. 2015. ; 11 ( 7 ): 773 – 827 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3. Levine M , Bennett K , Cantwell M , Postol K , Schwartz DB . Dental sleep medicine standards for screening, treating, and managing adults with sleep-related breathing disorders . J Dent Sleep Med. 2018. ; 5 ( 3 ): 61 – 68 . [Google Scholar]
- 4. Sutherland K , Dalci O . Fake it till you custom-make it: a non-inferior thermoplastic mandibular advancement device? Thorax. 2019. ; 74 ( 7 ): 629 – 630 . [DOI] [PubMed] [Google Scholar]
- 5. Sheats RD , et al . Identifying the appropriate therapeutic position of an oral appliance . J Dent Sleep Med. 2020. ; 7 ( 4 ). [Google Scholar]
- 6. Johal A , Haria P , Manek S , Joury E , Riha R . Ready-made vs custom-made mandibular repositioning devices in sleep apnea: a randomized clinical trial . J Clin Sleep Med. 2017. ; 13 ( 2 ): 175 – 182 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7. 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 Respir Crit Care Med. 2008. ; 178 ( 2 ): 197 – 202 . [DOI] [PubMed] [Google Scholar]
- 8. 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. ; 74 ( 7 ): 667 – 674 . [DOI] [PubMed] [Google Scholar]
- 9. 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 . [DOI] [PubMed] [Google Scholar]