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| Name | Class |
|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
| Shanghai Children's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug therapy | Active Comparator | Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months. |
|
| tonsillar adenoidectomy | Active Comparator | tonsillar adenoidectomy |
|
| orthodontic treatment | Active Comparator | Apply Twin-block appliance combined with maxillary expander |
|
| tonsillar adenoidectomy plus orthodontic treatment | Active Comparator | Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray | Drug | Mometasone Furoate Nasal Spray NASONEX |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Obstructive Apnea Index（OAI）/ Apnea Hypopnea Index （AHI） in PolySomnoGraphy （PSG） | OAI/AHI (which are in negative correlation with oxygen saturation) decrease after treatment | change from baseline at 7 months,1 year & 2 years post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Low arterial Oxygen Saturation （LSaO2） in PSG | LSaO2 increase after treatment | change from baseline at 7 months,1 year & 2 years post-treatment |
| Airway volume change as shown on Cone Beam Computer Tomography (CBCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanyuan Li, Doctor | Contact | 86-18817367760 | liyuanyuan831@sina.com | |
| Huanbqing Shan | Contact | 86-13564158276 | 362911628@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuehua Liu, Professor | Department of Orthodonitcs,Shanghai Stomatological Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Stomotological Hospital | Recruiting | Shanghai | 200001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32605655 | Derived | Li Y, Wu J, Guo J, Yu L, Wang J, Li X, Xu S, Zhu M, Feng J, Liu Y. The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular retrognathia: study protocol for a multicenter randomized controlled trial. Trials. 2020 Jun 30;21(1):595. doi: 10.1186/s13063-020-04398-9. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 28, 2024 | |
| Reset | Jan 16, 2025 |
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| tonsillar adenoidectomy |
| Procedure |
tonsillar adenoidectomy |
|
| Maxillary expander plus Twin-Block | Procedure | Twin-block appliance combined with maxillary expander |
|
Airway volume increase after treatment
| 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 | 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. | change from baseline at 7 months,1 year & 2 years post-treatment |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 28, 2024 | Jan 16, 2025 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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