Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion
NCT ID: NCT03451318
Last Updated: 2018-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2018-03-02
2020-05-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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drug therapy
Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months.
Mometasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray NASONEX
tonsillar adenoidectomy
tonsillar adenoidectomy
tonsillar adenoidectomy
tonsillar adenoidectomy
orthodontic treatment
Apply Twin-block appliance combined with maxillary expander
Maxillary expander plus Twin-Block
Twin-block appliance combined with maxillary expander
tonsillar adenoidectomy plus orthodontic treatment
Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy .
tonsillar adenoidectomy
tonsillar adenoidectomy
Maxillary expander plus Twin-Block
Twin-block appliance combined with maxillary expander
Interventions
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Mometasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray NASONEX
tonsillar adenoidectomy
tonsillar adenoidectomy
Maxillary expander plus Twin-Block
Twin-block appliance combined with maxillary expander
Eligibility Criteria
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Inclusion Criteria
2. Tonsil and/or adenoid hypertrophy
3. Narrow dental arch and / or mandibular retrusion (ANB value≥ 4.5)
4. The guardian / child can understand the study and sign the informed consent
Exclusion Criteria
2. The pathological obesity
3. Patients with systemic disease
4. Patient with central sleep apnea/hypopnea syndrome
4 Years
10 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Shanghai Children's Hospital
OTHER
Shanghai Stomotological Hospital
OTHER
Responsible Party
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Principal Investigators
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Yuehua Liu, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Orthodonitcs,Shanghai Stomatological Hospital
Locations
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Shanghai Stomotological Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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16CR2044B
Identifier Type: -
Identifier Source: org_study_id
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