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Clinical study of upper airway response in children with mandibular retrognathia and obstructive sleep apnea after Twin Block treatment during sleep

Clinical study of upper airway response in children with mandibular retrognathia and obstructive sleep apnea after Twin Block treatment during sleep

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037726
Enrollment
Unknown
Registered
2020-08-30
Start date
2020-09-06
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

Mandibular retrognathia and obstructive sleep apnea

Interventions

Sponsors

Shandong University Stomatological Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Intervention group: 1. Age: 8-12 years old; 2. SNA was normal (82.3 ± 3.5); 3. SNB is less than 74.7 degrees and chin apex is more than 0.5mm behind the plane of nasal root; 4. Anb is greater than 6.1 degrees; 5. Diagnosis of mild OSAS (AHI: 1-5 times / h); 6. The treatment of TB was completed; 7. Patients' family members sign informed consent. Non intervention group: 1. Age: matched with the age of intervention group after treatment; 2. SNA was normal (82.3 ± 3.5); 3. SNB is less than 74.7 degrees and chin apex is more than 0.5mm behind the plane of nasal root; 4. Anb is greater than 6.1 degrees; 5. Diagnosis of mild OSAS (AHI: 1-5 times / h); 6. Without TB correction; 7. Informed consent signed by family members of patients.. Normal control group: control group 1. Age: matched with the age before and after TB treatment in intervention group; 2. SNA was normal (82.3 ± 3.5); 3. SNB was normal (77.6 ± 2.9); 4. Anb was normal (4.7 ± 1.4); 5. AHI: < 1 time / h.

Exclusion criteria

Exclusion criteria: 1. Patients with obesity, adenoid and / or tonsillar hypertrophy, history of resection or orthodontic treatment, Down syndrome, neuromuscular disease, cerebral palsy, sickle cell disease or mucopolysaccharidosis and other potential airway diseases were excluded; 2. Patients diagnosed with central sleep apnea / hypopnea syndrome.

Design outcomes

Primary

MeasureTime frame
AHI;LSaO2;Pmin;Vmax;V;L;Smin;

Countries

China

Contacts

Public ContactDongxu Liu

Stomatological Hospital of Shandong University

liudongxu@sdu.edu.cn+86 13969086367

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026