Comparative evaluation of the efficacy of customized maxillary oral appliance with mandibular advancement appliance as a treatment modality for moderate obstructive sleep apnea patients—protocol for a randomized controlled trial

Abstract

Background Obstructive sleep apnea (OSA) is due to the obstruction of the upper airway during sleep. This condition is often associated with multiple symptoms and co-morbidities. There are many treatment options mentioned in the literature to manage OSA, among which interventional option of continuous positive airflow (CPAP) and non-interventional option, i.e., mandibular advancement device (MAD), which is an oral appliance (OA), are the most preferred ones. This study aims to evaluate the efficacy of customized maxillary oral appliances with mandibular advancement devices in moderate OSA patients. Methods A prospective interventional study with a randomized controlled trial will be carried out involving 40 participants (sample size), with an apnea-hypopnea index (AHI) > 15–30, recorded on polysomnography (PSG). Study participants will be randomly divided into the following treatment groups: control group or group subjected to mandibular advancement device (MAD, n=20) and second group subjected to customized maxillary oral appliance (CMOA, n=20). Baseline assessment of apnea/hypopnea index (AHI), oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth Sleepiness Scale will be done. Then both study group participants will receive their respective appliances. And after one month and three months of delivery of the appliance, all the parameters, i.e., AHI, oxygen saturation in blood, percentage of rapid eye movement, electroencephalogram, electrocardiogram, oro-nasal airflow via a pressure transducer, and Epworth Sleepiness Scale will be re-evaluated and compared with the baseline measurements. Descriptive and analytical statistics will be done. SPSS (Statistical Package for Social Sciences) Version 20.1 will be used as statistical software. The statistical significance between the two groups after one month and three months will be evaluated at p< 0.05. Discussion We expect, customized maxillary oral appliance to be more efficient in managing moderate OSA, in comparison with MAD. If the hypothesis of the present study is confirmed, then this customized maxillary appliance will be quoted as a “gold standard” for managing moderate OSA. Trial registration CTRI/2020/07/026936 Registered 31 July 2020.

Tratamiento del síndrome de apnea obstructiva del sueño: revisión de la literatura

“…Sin embargo, existen estudios que indican que los dispositivos o aparatos orales que logran una expansión maxilar y un avance mandibular pueden DIVULGACIÓN 36 ser usados para disminuir los índices de apneas e hipoapneas, brindando al paciente una mejor calidad de vida 8 . Del mismo modo, los aparatos bucomaxilares personalizados son de gran ayuda en casos de severidad moderada, pues logran un resultado más efectivo 17 . Los estudios avalan la efectividad de los dispositivos orales en todos los grados de severidad de SAOS y debido a su abordaje mínimamente invasivo mediante la distracción mandibular, se pueden lograr resultados inmediatos en los primeros milímetros de alargamiento de la rama mandibular y evita los riesgos comorbilidades futuras 1,8,17,18,24,25 .…”

“…Del mismo modo, los aparatos bucomaxilares personalizados son de gran ayuda en casos de severidad moderada, pues logran un resultado más efectivo 17 . Los estudios avalan la efectividad de los dispositivos orales en todos los grados de severidad de SAOS y debido a su abordaje mínimamente invasivo mediante la distracción mandibular, se pueden lograr resultados inmediatos en los primeros milímetros de alargamiento de la rama mandibular y evita los riesgos comorbilidades futuras 1,8,17,18,24,25 .…”

“…La cirugía ortognática logra grandes beneficios anatómicos como musculares, evitando el colapso de la vía aérea superior, las apneas e hipoapneas en el ciclo del sueño, mejorando de este modo la calidad de vida del paciente 21 . Es adecuado para los casos de severidad moderada y severa [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] .…”

Therapeutic Effect of Extended Uvulopalatal Flap Surgery in Patients With Obstructive Sleep Apnea

“…Treatment modalities for adult OSA can be mainly divided into surgical and non-surgical treatments such as drugs, oral appliances, and continuous positive airway pressure (CPAP) [1,[6][7][8][9]. The treatment method for a patient is carefully decided by considering the upper airway obstruction site, the severity of the disease, the presence of comorbidities, the compliance with CPAP use, and the patient's social requirements [10][11][12][13][14][15]. As the primary goal of surgical treatment is to widen the area of the upper airway that causes apnea during sleep, the operation range should be determined according to the extent of obstruction area and the obstruction site.…”

Comparison of the Effectiveness of Orthodontic Treatment with Adenotonsillectomy Procedures in Children with Obstructive Sleep Apnea (OSA)

“…The most common clinical entity among the variety of sleep-related respiratory problems in both adults and children is obstructive sleep apnea (OSA), is characterized by the recurring whole or a portion of the upper airways being blocked during sleeping, despite ongoing respiratory efforts [1][2][3][4][5][6]. The pharyngeal wall narrows or collapses as a result of upper airway blockage brought on by poor tongue and/or airway dilator muscle motor tone during sleep.…”