NCT06943443

Effect of Serum Vitamin D on MARPE Treatment Response

Evaluation of the Effects of Vitamin D Levels on Miniscrew-Assisted Rapid Palatal Expansion Treatment

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Konya Necmettin Erbakan Üniversitesi · Academic / Other
• Sex: All
• Age: 16 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2025-02-20
• Primary completion: 2025-08-30
• Completion: 2025-11-25
• First posted: 2025-04-24
• Last updated: 2025-08-26

Locations

1 site across 1 country: Turkey (Türkiye)