The aim of this study is to compare the efficacy and safety of drug therapy, tonsillar adenoidectomy only, orthodontic treatment only and tonsillar adenoidectomy plus orthodontic treatment in children with obstructive sleep apnea hypopnea syndrome (OSAHS) and malocclusion. In this study, we hope to improve children's OSAH in function, three-dimensional shape and subjective and objective symptoms of sleep breathing through tonsillar adenoidectomy plus orthodontic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Mometasone Furoate Nasal Spray NASONEX
tonsillar adenoidectomy
Twin-block appliance combined with maxillary expander
Shanghai Stomotological Hospital
Shanghai, China
RECRUITINGObstructive Apnea Index（OAI）/ Apnea Hypopnea Index （AHI） in PolySomnoGraphy （PSG）
OAI/AHI (which are in negative correlation with oxygen saturation) decrease after treatment
Time frame: change from baseline at 7 months,1 year & 2 years post-treatment
Low arterial Oxygen Saturation （LSaO2） in PSG
LSaO2 increase after treatment
Time frame: change from baseline at 7 months,1 year & 2 years post-treatment
Airway volume change as shown on Cone Beam Computer Tomography (CBCT)
Airway volume increase after treatment
Time frame: change from baseline at 7 months post-treatment
ANB, Frankfort plane- Mandibular plane Angle (FMA) measurement using X-ray cephalometrics.
ANB \& FMA (face development indicators) become normal after treatment
Time frame: change from baseline at 7 months,1 year & 2 years post-treatment
Assessment of subjective efficacy by using a "questionnaire on children's sleep symptoms"
Sleep quality improve after treatment.
Time frame: change from baseline at 7 months,1 year & 2 years post-treatment
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