背景:这项临床研究的目的是评估不同的快速上颌扩张矫治器对阻塞性睡眠呼吸暂停(OSA)严重程度的影响。
方法:上颌骨狭窄且患有OSA的患者随机分为三组:牙齿组织承载,牙托,和骨载扩张器。基线时睡眠参数的变化和3个月随访检测到的主要结果。交叉咬伤的治疗是次要结果。Dunn-Bonferroni测试,Kruskal-Wallis,和Wilcoxon分析用于p<0.05显著性水平的组内和组间差异。
结果:在随机分组的46例患者中,所有组的呼吸暂停低通气指数(AHI)从基线到随访均有变化(分别为-1.6,p=0.280;0.6,p=0.691;-0.45,p=0.796),组间无差异(p=0.631)。所有组的氧饱和度下降指数(ODI)从基线到随访都发生了变化(分别为0.80,p=0.977;0.20,p=0.932;和-1.00,p=0.379),组间无差异(p=0.858)。从基线到随访,所有组的最低血氧饱和度没有显着差异(分别为0.00,p=0.401;-2.00,p=0.887;0.50,p=0.407)。从基线到随访,所有组的仰卧位AHI均未观察到显着变化(分别为0.00,p=0.581;-1.00,p=0.393;0.00,p=0.972)。所有组的上磨牙间宽度从基线到随访均增加(分别为5.04,p=0.000;3.15,p=0.001;5.41,p=0.00),组间无差异(p=0.560)。从基线到随访,上颌宽度在所有组中增加(分别为4.25,p=0.001;4.74,p=0.00;4.49,p=0.001),组间无差异(p=0.963)。
结论:所有组的上颌骨和牙齿扩张量相似。在OSA治疗中,上颌快速扩张未发现有效。
背景:ClinicalTrials.gov标识符:NCT04604392。
The purpose of this clinical
study was to assess the effects of different rapid maxillary expansion appliances on the severity of obstructive sleep apnea (OSA).
Patients having a narrow maxilla and identified with OSA were divided randomly into three groups: tooth tissue-borne, tooth-borne, and bone-borne expanders. Changes in sleep parameters at baseline and 3-month follow-up detected by
polygraphy were the primary outcome. Treatment of the crossbite was the secondary outcome. Dunn-Bonferroni tests, Kruskal-Wallis, and Wilcoxon analysis were applied for intra- and inter-group differences at p < 0.05 significance level.
Among 46 patients randomized, apnea-hypopnea index (AHI) changed from baseline to follow-up in all groups (- 1.6, p = 0.280; 0.6, p = 0.691; - 0.45, p = 0.796, respectively), with no between-group difference (p = 0.631). Oxygen desaturation index (ODI) altered from baseline to follow-up in all groups (0.80, p = 0.977; 0.20, p = 0.932; and - 1.00, p = 0.379, respectively), with no between-group difference (p = 0.858). There was no significant difference in minimum oxygen saturation from baseline to follow-up in all groups (0.00, p = 0.401; - 2.00, p = 0.887; 0.50, p = 0.407, respectively). No significant changes were observed in supine AHI from baseline to follow-up in all groups (0.00, p = 0.581; - 1.00, p = 0.393; 0.00, p = 0.972, respectively). The upper intermolar width increased from baseline to follow-up in all groups (5.04, p = 0.000; 3.15, p = 0.001; 5.41, p = 0.00, respectively) with no between-group difference (p = 0.560). Maxillary width increased from baseline to follow-up in all groups (4.25, p = 0.001; 4.74, p = 0.00; 4.49, p = 0.001, respectively) with no inter-group difference (p = 0.963).
The amount of skeletal and dental expansion obtained in the maxilla was similar in all groups. Rapid maxillary expansion was not found to be effective in OSA treatment.
ClinicalTrials.gov Identifier: NCT04604392.