Trial | NCT03451318  Report issue

Title

Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion
A Multicenter Study of Establishing the Multi-disciplinary Cooperative Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    400
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 Started
Mar 02
2018
Primary Completion
May 30
2019
Anticipated
Study Completion
May 30
2020
Anticipated
Last Update
Apr 19
2018

Drug Mometasone Furoate Nasal Spray

Mometasone Furoate Nasal Spray NASONEX

Procedure tonsillar adenoidectomy

tonsillar adenoidectomy

Procedure Maxillary expander plus Twin-Block

Twin-block appliance combined with maxillary expander

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 .

Criteria 

Inclusion Criteria:

Diagnosed as mild to moderate OSAHS
Tonsil and/or adenoid hypertrophy
Narrow dental arch and / or mandibular retrusion (ANB value≥ 4.5)
The guardian / child can understand the study and sign the informed consent

Exclusion Criteria:

Patients with nasal obstruction disease
The pathological obesity
Patients with systemic disease
Patient with central sleep apnea/hypopnea syndrome
No Results Posted