Dento-skeletal Effects of Quadhelix Versus Mini-hyrax Expanders in Patients With Cleft Lip and Pa… (NCT07465939) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dento-skeletal Effects of Quadhelix Versus Mini-hyrax Expanders in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Randomized Clinical Trial
Egypt24 participantsStarted 2025-05-29
Plain-language summary
Regarding expansion in cleft lip and palate patients, very few clinical trials were found after searching literature and fewer randomized trials. This means that no enough evidence in literature is tackling expansion in cleft lip and palate patients.
To the best of our knowledge, this study will represent the first RCT to compare the dentoskeletal effects of mini-hyrax vs quadhelix. Since cleft cases usually need greater anterior than posterior expansion, both appliances are capable of anterior expansion. Nevertheless, no other study compared how much anterior expansion could be accomplished by either appliance.
Who can participate
Age range
6 Years – 12 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
. Mixed dentition.
. Both males and females.
. Unilateral cleft lip and palate
. Presence of maxillary constriction that needs maxillary expansion prior to secondary alveolar bone grafting.
. Erupted first permanent maxillary molars.
. Good periodontal health.
. No previous orthodontic treatment
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
Anterior transverse dento-skeletal effects measured by linear distance tool between deciduous upper canines on CBCT and digital models (axial view)