Oral appliances for obstructive sleep apnea

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.

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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

Belkhode

Godbole

Nimonkar

et al. 2022

Trials

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

Belkhode

Godbole

Nimonkar

et al. 2023

Trials

Self Cite

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Background Obstructive sleep apnea (OSA) is quite common among the adult population, according to recent epidemiological studies. The most frequently suggested alternate treatment for mild to moderate OSA is oral appliances (OA). The purpose of the present study was to assess as well as compare the effectiveness of custom-made maxillary oral appliances against mandibular advancement appliances in the care of individuals suffering from moderate obstructive sleep apnea. Methods A prospective interventional research was carried out with 40 participants. Polysomnography (PSG) was done and the participants with an apnea-hypopnea index (AHI) >15–30 were involved in the research. Study participants were randomly split up into two test groups: group I was the “Control Group” (group treated with a mandibular advancement device (MAD), n=20), while group II was exposed to a “customized maxillary oral appliance” (CMOA, n=20). Both groups had reference measures for AHI, blood oxygen saturation (SpO2), oro-nasal airflow via respiratory disturbance index (RDI), and the Epworth Sleepiness Scale (ESS). Appliances were fabricated and delivered to the respective study group participants. PSG was again conducted after a period of 1 and 3 months of appliance delivery and re-evaluation was done for all the parameters and was compared with reference measurements. The facts were analyzed using descriptive and analytical statistical methods. The statistical program utilized in the study was “SPSS (Statistical Package for Social Sciences) Version 20.1.” After 1 and 3 months, the statistical significance between the two study groups was assessed at P<0.05. Results The analysis of mean AHI, SPO2, RDI, and ESS for both test groups manifested statistically significant measures (P<0.001). The study results revealed a statistically significant depletion in mean AHI scores, improvement in mean SPO2 scores, and reduction in mean RDI scores and ESS scores when compared with reference measurements to 1 month, 1 to 3 months, and between reference measurements and 3 months. Conclusion The CMOA was effective in managing moderate OSA and has great therapeutic potential. It can be an option for the MAD for treating patients suffering from moderate obstructive sleep apnea. Trial registration The study was registered under Clinical Trials Registry-India and the registration number is CTRI/2020/07/026936. Registered on 31 July 2020

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

Achmad¹

2022

J Dent Oral Sci

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Background: Obstructive Sleep Apnea Syndrome (OSA) is a syndrome of total or partial obstruction of the airways, leading to significant disturbances with varying clinical impact. In children, the main cause is thought to be overgrowth (hypertrophy) of the tonsils and adenoids, as well as structural abnormalities in Pierre Robin and Down Syndrome. The airway structures are significantly narrowed in children with head-face bone abnormalities or craniofacial anomalies, causing them to experience airway obstruction even in the absence of adenoid hypertrophy. The incidence of OSA in children needs to be observed as well as rising risk factors such as obesity. Pediatric obstructive sleep apnea (OSA) is typically treated with an adenotonsillectomy and the use of orthodontic procedures including rapid maxillary expansion and mandibular advancement devices. Each approach has different treatment advantages. Systematic reviews and meta-analysis of OSA treatments have been reported, however there have been relatively few comparisons of various treatments. In a systematic review of the evidence for the efficacy of AT and orthodontic treatment, Templier et al. concluded that combined AT orthodontic treatment (RME and/or MAD) was more effective than either therapy alone for treating OSA in pediatric patients. Objective: To systemically analyze the literature on the effectiveness of orthodontic treatment with adenotonsillectomy surgery in children with obstructive sleep apnea (OSA) and to identify differences in the two treatments’ effectiveness. Conclusion and implications: The effectiveness of adenotonsillectomy, orthodontic treatment, and orthodontic treatment combined with adenotonsillectomy was assessed in children with mild OSA and mandibular retrognathia. That study, which needed a large sample size (352 children) and had a high dropout rate, revealed that combine orthodontic adenotonsillectomy (RME and/or MAD treatment) was more effective when given simultaneously than when given individually for treating OSA in pediatric patients. To date, the effectiveness of these two treatments cannot currently be compared due to a lack of strong evidence. If the treatment outcomes were unsatisfactory at 7 months after the initial treatment, subjects could receive further treatment following assessment by a stomatologist and ear, nose, and throat (ENT) specialist. Limitations: Of the 10 publications included in this review, 8 were randomized controlled trials, the remaining 2 non-randomized research journals were vulnerable to many biases that impair the certainty of the evidence gained, especially by confounding factors and the lack of control groups.

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Oral appliances for obstructive sleep apnea

Cited by 6 publications

References 22 publications

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

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

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

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

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