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Clinical Trial
. 2014 Oct;124(10):2427-32.
doi: 10.1002/lary.24607. Epub 2014 Mar 1.

Adjustable thermoplastic mandibular advancement device for obstructive sleep apnea: outcomes and practicability

Wish Banhiran  1 , Phantipar Kittiphumwong, Paraya Assanasen, Cheerasook Chongkolwatana, Choakchai Metheetrairut
Affiliations
Clinical Trial

Adjustable thermoplastic mandibular advancement device for obstructive sleep apnea: outcomes and practicability

Wish Banhiran et al. Laryngoscope. 2014 Oct.

Abstract

Objectives/hypothesis: To assess outcomes including efficacy, adverse effects, and quality of life (QOL) of an adjustable thermoplastic mandibular advancement device (AT-MAD) fitted by an otolaryngologist for obstructive sleep apnea (OSA) treatment.

Study design: Prospective, nonrandomized, before-after study.

Methods: Sixty-four adult patients (40 men and 24 women) were recruited. Inclusion criteria were OSA patients who had failed or refused treatment with continuous positive airway pressure and surgery. Exclusion criteria were insufficient teeth, active intraoral disease, and temporomandibular joint (TMJ) disorders. Outcomes were measured using polysomnography, symptom questionnaires, Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire (FOSQ) before treatment and 4 to 6 months thereafter.

Results: Mean apnea-hypopnea index (AHI) and ESS scores decreased from 17.7 ± 14.6 to 7.5 ± 10.9 and from 8.7 ± 4.9 to 6.5 ± 4.4, respectively, after treatment (P < .001). Thirty-nine patients (60.9%) achieved post-treatment AHI of <5, with the highest success rate in those with mild OSA (75%). FOSQ global scores increased from 16.4 ± 2.8 to 17.7 ± 3.0 (P < .05), along with most FOSQ subscale scores. Thirty-four patients (53.1%) regularly used the device for ≥5 nights per week. Adverse effects include TMJ discomfort, dry mouth, and excessive salivation, which were largely tolerable. Only four patients withdrew from the study because of adverse effects.

Conclusions: This is the first study in Asians demonstrating that an AT-MAD, if done properly, is a practical short-term treatment of OSA, with good outcomes including improved QOL. Its advantages are its low cost and ready-to-use nature. However, further randomized controlled trials are required.

Keywords: Asian; Obstructive sleep apnea; Somnoguard; Thai; mandibular advancement splint; oral appliances; quality of life; thermoplastic.

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