Modified biblock versus monoblock mandibular advancement appliances for treatment of obstructive sleep apnea: A randomized controlled trial.

Statement Of Problem: The high prevalence of obstructive sleep apnea represents a serious public health problem. Oral appliances have gained wide acceptance among patients diagnosed with obstructive sleep apnea, who should wear them every night. A comfortable oral appliance is mandatory for successful treatment outcomes.

Purpose: The purpose of this randomized controlled trial was the assessment of the influence of 2 different designs of the mandibular advancement appliance (MAA), modified biblock and monoblock, for the management of obstructive sleep apnea.

Material And Methods: The study was designed as a prospective 2-arm randomized controlled clinical trial conducted in parallel. Twenty participants (aged 40 ±7.5 years) diagnosed with moderate obstructive sleep apnea were randomly assigned to a control group (n=10), receiving monoblock MAA, and a study group (n=10), receiving modified biblock MAA with elastics. Both appliances were fabricated by using computer-aided design and computer-aided manufacture (CAD-CAM) technology at different mandibular advancement levels (MALs): 50% and 75% of maximum MAL. A total of 60 cone beam computed tomography scans, 60 overnight full polysomnography sleep tests, 60 STOP-Bang questionnaires, and 40 Usability of Sleep Apnea Equipment-Oral Appliance (USE-OA) questionnaires were collected and analyzed blindly at baseline (initial visit), 50% MAL (3 months), and 75% MAL (6 months). The main outcome measures were the upper airway volume, linear anteroposterior and cross-sectional airway measurements, Apnea Hypopnea Index, Respiratory Disturbance Index, STOP-Bang questionnaire scoring, and USE-OA questionnaire scoring. Nonparametric statistical analysis was performed by using a statistical software program (α=.05). With a beta error accepted of up to 20%, the power of the study was 80%.

Results: At 75% MAL, the percentage change in upper airway volumetric measurements showed a favorable increase: biblock group (115%) and monoblock group (42%), with a statistically significant difference (P=.001). The linear anteroposterior airway measurements and the percentage change in cross-sectional airway measurements were statistically similar: biblock group (80%) and (75%) monoblock group (60%), (54%) (P=.450, P=.151, respectively). The percentage change in the Apnea Hypopnea Index significantly decreased: biblock group (-89%) and monoblock group (-54%) (P<.001). The percentage change in the Respiratory Disturbance Index decreased: biblock group (-78%) and monoblock group (-62%) (P<.023). From the STOP-Bang questionnaire scoring, 100% of both groups showed low risk for obstructive sleep apnea at 75% MAL. From the satisfaction scoring on the USE-OA questionnaire, the biblock group was 100% strong satisfaction and the monoblock group was 50% satisfaction and 50% fairly satisfied.

Conclusions: The modified biblock MAA with elastics showed significant improvements in patients diagnosed with obstructive sleep apnea regarding upper airway measurements and full polysomnography vital parameters when compared with monoblock MAA.