Effect of Serum Vitamin D on MARPE Treatment Response

NCT06943443 | Enrolling By Invitation

• 1 other identifier: 2025550
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Marpe

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Change in Serum Vitamin D Levels

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

Study Arms (2)

Intervention Group MARPE Treatment with Vitamin D Supplementation

EXPERIMENTAL

This group will receive Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment combined with Vitamin D supplementation. The patients in this group will undergo MARPE treatment for palatal expansion and receive Vitamin D supplementation according to the levels identified by their endocrinology evaluation at the beginning of the study. Vitamin D supplementation aims to optimize bone metabolism during the treatment process. Serum Vitamin D levels will be monitored before and after treatment to assess the effectiveness of supplementation in improving treatment outcomes.

Device: Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment

Control Group MARPE Treatment without Vitamin D Supplementation

ACTIVE COMPARATOR

Arm Description: This group will undergo Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment without any Vitamin D supplementation. The patients in this group will receive standard MARPE treatment for palatal expansion, and their serum Vitamin D levels will not be measured or supplemented during the study. The aim of this group is to serve as a comparison to evaluate the effects of Vitamin D supplementation in the experimental group.

Device: Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment

Interventions

Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment DEVICE

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

Control Group MARPE Treatment without Vitamin D Supplementation; Intervention Group MARPE Treatment with Vitamin D Supplementation

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

Study Sites (1)

Faculty Of Dentistry

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (1)

• Al-Attar A, Abid M. The Effect of Vitamin D3 on the Alignment of Mandibular Anterior Teeth: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Feb 14;2022:6555883. doi: 10.1155/2022/6555883. eCollection 2022.

  PMID: 35198025 RESULT

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/ Research Assistant

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 24, 2025
• Study Start: February 20, 2025
• Primary Completion: August 30, 2025
• Study Completion: November 25, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Individual participant data (IPD) and supporting information will be available for sharing starting from February 20, 2025, and will remain accessible until November 25, 2025. During this time, researchers can request access to de-identified data for further scientific investigations.

Locations

TU (1)