MedTrace Logo

Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion

NCT03451318 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2018-04-19

No results posted yet for this study

Summary

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.

Conditions

  • Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion

Interventions

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

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    collaborator OTHER

  • Shanghai Children's Hospital

    collaborator OTHER

  • Shanghai Stomotological Hospital

    lead OTHER

Principal Investigators

  • Yuehua Liu, Professor · Department of Orthodonitcs,Shanghai Stomatological Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-02
Primary Completion
2019-05-30
Completion
2020-05-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03451318 on ClinicalTrials.gov