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Clinical Trials in Turkey / NCT06943443
Enrolling by invitation Not applicable

Effect of Serum Vitamin D on MARPE Treatment Response

NCT06943443 · tracked via the Priya Life Science Turkey tracker
Sponsor
Konya Necmettin Erbakan Üniversitesi
Phase
Not applicable
Started
2025-02-20
Last updated
2025-08-26

Condition(s) studied

Maxillary Transverse Deficiency Class I Malocclusion Vitamin D Deficiency Orthodontic Tooth Movement Adolescent Health

Investigational drug(s) / intervention(s)

Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment

Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment: Vitamin D Supplementation: Vitamin D plays a crucial role in calcium absorption, bone health, immune system function, and cellular growth. It is primarily obtained through sunlight exposure, certain foods, and supplements. In the context of your study, Vitamin D supplementation will be used to improve the Vitamin D levels in patients undergoing Miniscrew-Assisted Rapid Palatal Expansion (MARPE) treatment. Key Points: Purpose: To correct Vitamin D deficiency, which may affect bone metabolism and orthodontic treatment outcomes. Administration: Vitamin D supplementation is typically provided in the form of oral tablets or soft gels, with a usual dosage of 800-2000 IU per day, depending on the individual's baseline levels. Measurement: Vitamin D levels will be measured at the beginning and end of treatment using 25-hydroxyvitamin D (25(OH)D tests to assess the effectiveness of supplementation. Effect on MARPE: Adequate Vitamin D levels may support better bone remodeling and healing, pote

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
18 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change in Intermolar and Intercanine Widths After MARPE Treatment — At baseline (T1) and after expansion phase (T2), approximately 6 weeks apart
    Intermolar and intercanine width changes will be assessed using intraoral digital scans obtained with an iTero scanner. The width measurements will be made using ORTHOCAD software to determine the amount of skeletal expansion achieved with MARPE treatment.

Trial sites (1)

FacilityCityRegionStatus
Faculty Of Dentistry Konya Meram

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06943443 on ClinicalTrials.gov ↗ ← All trials in Turkey