Action/timepoint | Enrollment |
Baseline survey (M 0) | Randomization | Treatment | Follow-up (M 7) | Follow-up (M 12) | Follow-up (M 24) |
---|---|---|---|---|---|---|---|
Informed consent | ⚪ | ||||||
Demographic characteristics | ⚪ | ||||||
Medical history | ⚪ | ||||||
Physical examination | ⚪ | ||||||
Questionnaire (OSA-20) | ⚪ | ||||||
Lateral cephalometrics | ⚪ | ⚪ | ⚪ | ⚪ | |||
Polysomnogram | ⚪ | ⚪ | ⚪ | ⚪ | |||
Confirm suitability for study | ⚪ | ||||||
Allocation | ⚪ | ||||||
Drug treatment | ⚪ | ||||||
Surgical treatment | ⚪ | ||||||
Orthodontic treatment | ⚪ | ||||||
Surgery and postoperative orthodontic treatment | ⚪ | ||||||
Assessment | |||||||
Symptom changes | ⚪ | ⚪ | ⚪ | ||||
Questionnaire (OSA-20) | ⚪ | ⚪ | ⚪ | ⚪ | |||
Cephalometric measurements | ⚪ | ⚪ | ⚪ | ⚪ | |||
Morphologic analysis of UA | ⚪ | ⚪ | ⚪ | ⚪ | |||
Polysomnogram | ⚪ | ⚪ | ⚪ | ⚪ | |||
Safety assessment | ⚪ | ⚪ | ⚪ |