Effect of Serum Vitamin D on MARPE Treatment Response

N/AEnrolling By InvitationNCT06943443

Konya Necmettin Erbakan Üniversitesi20 enrolled

Overview

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.

This randomized clinical trial aims to evaluate the potential impact of serum vitamin D levels on the outcomes of Miniscrew-Assisted Rapid Palatal Expansion (MARPE) treatment in young adults aged 15-18 years. A total of 30 patients presenting with maxillary transverse deficiency will be recruited during the first half of 2025. Patients will be randomly allocated to two groups. The intervention group will undergo vitamin D level assessment at the beginning of treatment and receive supplementation if found deficient, while the control group will proceed without initial vitamin D evaluation. Serum 25-hydroxyvitamin D \[25(OH)D\] levels will be measured at T1 and T2 timepoints. Intraoral scans will be performed using an Itero device to assess changes in intercanine and intermolar widths, and the data will be analyzed using the ORTHOCAD software. Pain levels will be recorded by the patients using a Visual Analog Scale (VAS) on specified days during the expansion phase. This study intends to determine whether baseline vitamin D status and subsequent supplementation can improve the biological response and clinical efficiency of MARPE treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Interventions

Miniscrew-Assisted Rapid Palatal Expansion (MARPE) TreatmentDEVICE

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Intermolar and Intercanine Widths After MARPE Treatment

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.

Time frame: At baseline (T1) and after expansion phase (T2), approximately 6 weeks apart

Secondary Outcomes

Change in Serum Vitamin D Levels

Serum 25-hydroxyvitamin D \[25(OH)D\] levels will be measured in both groups. The intervention group will have levels assessed at T1 and T2, and supplementation will be given if initial levels are suboptimal. The control group will have levels assessed only at T2.

Time frame: Baseline (T1) and Post-treatment at Week 8 (T2)