Three-Dimensional Evaluation of Pharyngeal Airway and Facial Dimension Changes in Skeletal Class … (NCT06976749) | Clinical Trial Compass
By InvitationNot Applicable
Three-Dimensional Evaluation of Pharyngeal Airway and Facial Dimension Changes in Skeletal Class II Patients Treated With Twin Block Versus Myobrace Appliances
Iraq50 participantsStarted 2025-05-20
Plain-language summary
This study is intended primarily to compare the effects of two Class II correction appliances, namely Twin block and Myobrace appliances, on pharyngeal airway dimensions during the treatment of class II division 1 adolescent patients, also evaluates three dimensional (3D) changes of pharyngeal airway including: minimum cross-sectional area and volume using Cone Beam Computed Tomography (CBCT), skeletal, dentoalveolar, and soft tissue changes using cephalometric analysis, and three dimensional (3D) soft tissue changes using facial scans. The hypothesis being a consideration of no significant difference in the changes of pharyngeal airway and facial dimensions in skeletal class II patients before and after treatment with Twin block and Myobrace.
Who can participate
Age range
10 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 10-14 years, at growth spurt phase as determined by the cervical vertebrae maturation stage (C3- C4 ) assessed by lateral cephalograms.
. Skeletal relationship: skeletal class II (ANB angle \> 4°) with normal maxilla (SNA angle 78°- 84°), and retrognathic mandible (SNB angle \< 77 °).
. Dental relationship: Moderate to severe dental class II division 1 malocclusion with overjet 6 -10 mm.
. Convex facial profile.
. Well aligned/mild crowding (\< 4 mm) of dental arches.
. Good to fair oral hygiene status as based on a simplified oral hygiene index (OHI-S).
. Normal or decreased lower facial height (SN-MP angle ≤ 32).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
minimum cross-sectional area of the pharyngeal airway in (mm^2) using Cone Beam Computed Tomography (CBCT)
Timeframe: From enrollment to the end of treatment at 6 months