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

Shanghai Stomotological Hospital

Status: Unknown

Conditions: Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion

Treatments: Drug: Mometasone Furoate Nasal Spray; Procedure: tonsillar adenoidectomy; Procedure: Maxillary expander plus Twin-Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03451318

16CR2044B

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed as mild to moderate OSAHS
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

1. Patients with nasal obstruction disease
2. The pathological obesity
3. Patients with systemic disease
4. Patient with central sleep apnea/hypopnea syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

drug therapy

Active Comparator group

Description:

Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months.

Treatment:

Drug: Mometasone Furoate Nasal Spray

tonsillar adenoidectomy

Active Comparator group

Description:

tonsillar adenoidectomy

Treatment:

Procedure: tonsillar adenoidectomy

orthodontic treatment

Active Comparator group

Description:

Apply Twin-block appliance combined with maxillary expander

Treatment:

Procedure: Maxillary expander plus Twin-Block

tonsillar adenoidectomy plus orthodontic treatment

Active Comparator group

Description:

Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy .

Treatment:

Procedure: tonsillar adenoidectomy

Procedure: Maxillary expander plus Twin-Block