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.

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.