Effect of Serum Vitamin D on MARPE Treatment Response (NCT06943443) | Clinical Trial Compass
By InvitationNot Applicable
Effect of Serum Vitamin D on MARPE Treatment Response
Turkey (Türkiye)20 participantsStarted 2025-02-20
Plain-language summary
A total of 30 patients are planned to be included in the study during the first half of 2025, who will apply to the clinic. In our clinical routine, approximately 30% of RME patients are treated using the MARPE method. The patients will be randomly assigned to two different groups. The first group will be referred to the Pediatric Endocrinology outpatient clinic at NEU Faculty of Medicine for vitamin D level measurements at the beginning of the treatment. The second group will proceed with treatment as usual, without vitamin D measurement. At the end of the treatment, vitamin D levels of all patients in both groups will be measured.
Who can participate
Age range
16 Years – 18 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:
* Patients diagnosed with Class I malocclusion
* Presence of maxillary transverse deficiency
* Adolescents aged between 15 and 18 years
* No systemic diseases, cleft lip/palate, or speech disorders
* No history of prior orthodontic treatment
* Willingness to undergo serum vitamin D testing
* Voluntary participation in the study with signed informed consent
* Good oral hygiene status
Exclusion Criteria:
* Patients with systemic diseases
* Patients who smoke
* Patients with poor oral hygiene
* Patients with cooperation or compliance issues
* Patients with intellectual disabilities
* Patients with unmonitored or insufficient pre-treatment vitamin D levels, including:
* Those who had insufficient vitamin D levels before treatment, were started on supplementation by the endocrinology department, but still had insufficient levels at the T2 measurement
* Those who were not tested before treatment but were found to have sufficient vitamin D levels only at T2
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 Intermolar and Intercanine Widths After MARPE Treatment
Timeframe: At baseline (T1) and after expansion phase (T2), approximately 6 weeks apart