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Functional therapy and Adenotonsillectomy Clinical Trial for Class II malocclusion (FACT-II): A Randomized Controlled Trial

Functional therapy and Adenotonsillectomy Clinical Trial for Class II malocclusion (FACT-II): A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061703
Enrollment
Unknown
Registered
2022-06-30
Start date
2022-06-30
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pediatric obstructive sleep apnea

Interventions

Test group:The adenotonsillectomy and postoperative functional therapy using Twin-Block appliance
Active control group:The functional therapy using Twin-Block appliance(the adenotonsillectomy was performed if necessary after functional therapy)

Sponsors

School and Hospital of Stomatology, Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 14 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria are as follows: 1. Patients aged 8 to 14 years, who are at the peak of puberty (CVM stage 3) or before. 2. Patients with class II division 1 relationship, skeletal class II malocclusion and mandibular retraction (ANB>= 4°, overjet of 5 mm or more); 3. Patients with no obvious symptom of temporomandibular disorders; 4. Patients with oral breathing or snoring during sleep, diagnosed with mild to moderate OSA (apnoea hypopnoea index (AHI) 1~10 events per hour during a period of not less than 7 hours of consecutive sleep according to PSG measurement); 5. Patients diagnosed with hypertrophy of adenoid and (or) tonsil by otorhinolaryngologist, eligible for the adenotonsillectomy. 6. Patients who were willing to participate in the study and had written informed consent from their caregivers; 7. Patients with good dental health.

Exclusion criteria

Exclusion criteria: The exclusion criteria are as follows: 1. Patients with acute upper respiratory infection. 2. Patients with body mass index (BMI) above cut off points of overweight(BMI> 25kg/m^2). 3. Patients diagnosed with severe OSA (AHI> 10/h). 4. Patients with previous adenotonsillectomy or orthodontic treatment. 5. Patients with craniofacial abnormality, neuromuscular disease and cardiopulmonary disease.

Design outcomes

Primary

MeasureTime frame
ANB angle;Apnea/Hypopnea Index;

Secondary

MeasureTime frame
The morphologic change in upper airway dimension;lowest oxyhemoglobin saturation (LSaO2);Quality of life (subjective symptoms);Oral Health-related Quality of Life;

Countries

China

Contacts

Public ContactHong He

School and Hospital of Stomatology, Wuhan University

1755850704@qq.com+86 189 7166 2305

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026