Abstract
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.
Validating pre-treatment body mass index as moderator of antidepressant treatment outcomes: Findings from CO-MED trial
