Fixed Versus Conventional Twin Block Appliances for Skeletal Class II Malocclusion (NCT07687927) | Clinical Trial Compass
CompletedNot Applicable
Fixed Versus Conventional Twin Block Appliances for Skeletal Class II Malocclusion
Egypt20 participantsStarted 2023-11-08
Plain-language summary
This study compares two types of dental appliances a fixed Twin Block appliance and a conventional (removable) Twin Block appliance used to treat a bite problem called skeletal Class II malocclusion in growing children and teenagers. In this condition, the lower jaw is positioned further back than the upper jaw. Both appliance types work by guiding the lower jaw forward during growth. The study uses 3D imaging (cone beam computed tomography, or CBCT) before and after treatment to measure how each appliance affects the bones of the jaw, the teeth, the soft tissue profile of the face, and the jaw joint (temporomandibular joint). The goal is to determine whether the fixed or the conventional version of the appliance produces better treatment outcomes.
Who can participate
Age range
11 Years – 15 Years
Sex
MALE
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
. Growing male patients (as judged from clinical examination and confirmed later by (CVM)
. Skeletal class II with retrognathic mandible.
. Healthy compliant and motivated patient.
. No Previous orthodontic treatment.
. No Severe facial asymmetry determined by clinical or radiographic examination.
. No Systemic diseases that may affect the treatment results.
. No tmj disorders.
Exclusion criteria
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
Change in Sagittal Skeletal Relationship (ANB Angle)
Timeframe: Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)