Author ContributionsDL and BB designed the study. DL and RO performed that statistical analyses. All authors were involved in the interpretation of the results and preparation of the manuscript. AcknowledgementsWith their permission, the authors wish to thank Dorian Cruz Arista, DA and Teresa Fregoso RDA for their assistance in fitting the Apnea Guards and extracting data from the patient records, Todd Morgan DMD and William Odom DDS for their oversight of the cost-containment protocol, Samuel Clark MD for assistance in interpreting the home sleep studies, and William Hevener, RPSGT for his assistance in identifying and referring patients intolerant of positive airway pressure for this study.
Introduction CPAP was previously considered the “gold standard” due to its high efficacy in eliminating obstructive events. Despite improvements in technology, the “effectiveness” of CPAP has been compromised by poor real-world compliance. Technological improvements have improved the “effectiveness” of Oral Appliances. This study reports the efficacy of a novel, precision engineered Oral Appliance for the primary treatment of all severities of OSA. Methods Digital scans and digital bite registrations were recorded with a George Gauge utilizing a a 3mm bite fork. Initial protrusion was set at 40–60% and varied according to the degree of overbite and overjet, the severity of OSA, and the presence or absence of TMJ symptoms. All patients were fitted with a ProSomnus (IA) MAD and titrated according to their subjective symptoms. An efficacy study was obtained with a HST after titration and compared to the initial PSG or HST. Results Outcome data on 85 patients (37 female, 48 males, aged 56.7 +/1 10.2 years) was retrospectively reviewed. The patients were consecutively ordered for follow up data, many patients did not return for follow ups. The pre-treatment AHI was 24.5 +/- 19.1 with 36 patients Mild, 26 Moderate and 23 Severe patients. O2 Nadir was 84.1% +/- 5.5%. Post treatment AHI was 5.5 +/- 4.9 with an AHI reduction of 71.6% +/- 20.3%. 59% of the patients scored <5, 31% 10 on the outcome AHI data. O2 Nadir improved to 88.2% overall. 31 patients had RERA’s (RDI-AHI) >10 with an average of 16.7 +/- 7.5, of these patients 27 saw a reduction of RERA’s of 54.4% from 16.9 to 7.1. Conclusion The data shows that a precision oral appliance is capable of successfully treating patients with all levels of severity, with the majority of patients treated to an AHI<5. 23 severe patients with an average AHI of 49.7 were treated to a final average of 8.6, 4 of the patients scored above 10. Additionally, patients successfully saw a reduction in upper airway resistance airflow as evidenced by a reduction of RERA’s of 54.5%, showing that a precision oral appliance can have a significant impact on the upper airway. Support (if any) None
Purpose Assess the impact of custom oral appliance (CA) fabrication settings on treatment outcomes. Methods CPAP-intolerant patients completed a two-night home-sleep-apnea study (HSAT); Night1=baseline, Night2=Apnea Guard® trial appliance (AG). The AG vertical-dimension-of-occlusion (VDO) selection was based on tongue-scallop (women=5.5/6.5 mm, men= 6.5/8.0 mm), with a target protrusion of 70% from neutral-maximum while in situ. Study1 CA VDO was dependent on sex (women=2.5 mm, men=5 mm), with protrusion set using a George-Gauge measured 70% from maximum retrusion-protrusion with dentist-directed titration. Study2 CA was fabricated to the AG VDO and target protrusion bite-registration. Efficacy HSATs were conducted after completion of Study1 CA titration with vertical-elastics optional, and at the AG target protrusion with vertical-elastics mandatory in Study2. Statistics included Mann-Whitney, Chi-squared, and Bland-Altman analyses. Results The Study1 (n=84) and Study2 (n=46) distributions were equivalent for tongue-scallop (64/63%) and sex (women=45/41%), however, noted differences in age (53.8±11.9 vs. 58.4±12.2; P=0.052), body-mass-index (29.4±5.7 vs. 27.8±4.0; P=0.128) and pre-treatment AHI severities (24.6±14.4 vs. 29.2±17.4 events/h; P=0.155) were observed. The Bland-Altman biases were significant different (Study1=4.2±7.8 vs. Study2=1.3±7.0 events/h, P=0.035). The significant Study1 differences between the CA vs. AG AHIs (12.3±9.2 vs. 8.2±5.9 events/h, P<0.0002) were not apparent in Study2 (11.7±8.0 vs. 10.4±6.7 events/h, P=0.362), however, the Study2 AG AHI values were higher (P=0.055). Discussion Despite the trend toward greater Study2 pre-treatment and AG AHI severities, CA treatment efficacy was equivalent to the AG once VMO was controlled and fabricated using the AG VDO and protrusion bite-registration. These findings confirmed CA fabrication settings impact treatment outcomes.
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