Validation of X-ray Protocols in Cleft Children (NCT05351372) | Clinical Trial Compass
CompletedNot Applicable
Validation of X-ray Protocols in Cleft Children
Sweden72 participantsStarted 2016-05-31
Plain-language summary
Children born with an alveolar cleft receive bone grafts for improved function and aesthetics. The cleft area is radiologically examined before and post bone graft. Optimizing x-ray examination protocols is essential to protect these patients from possible delayed radiation injury later in life. This study investigates whether image quality of cone-beam computed tomography (CBCT) exposed with an ultra-low dose (ULD) protocol is comparable to the clinical default protocol, the standard dose (SD) protocol, in visualizing details of importance in bone grafting of alveolar clefts.
Methods In this randomized controlled study, 72 patients with uni- or bilateral alveolar clefts between 9-19 years (mean age 9.5) were randomized 1:1 with either a ULD or an SD CBCT examination protocol. The CBCT scans were conducted with Planmeca ProMax Mid with an 8x5cm field of view. Two experienced radiologists blindly evaluated the images and visibility of cortical bone border, trabecular bone, tooth anatomy, root development, periodontal space, and cleft width. The visibility was categorized as unacceptable, acceptable, or excellent.
Who can participate
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:
* Patients with cleft involving the alveolar process undergoing treatment at Stockholm Craniofacial Centre
* Reason for referral is CBCT examination in order to evaluate anatomy of the anterior maxilla prior to or after bone augmentation of the cleft
* Patient/parent has given informed consent to participate in the study.
Exclusion Criteria:
* No informed consent is given. Those patients will be examined according to standard clinical procedures.
* Patients with a medical history of disorder/syndrome/chronic disease that will affect both the examination and the outcome.
* No CBCT examination of the cleft area.
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.