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Enrolling by invitation NCT06943443

Effect of Serum Vitamin D on MARPE Treatment Response

No phase Interventional Maxillary Transverse Deficiency Class I Malocclusion Vitamin D Deficiency Orthodontic Tooth Movement Adolescent Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment.
Who it may be relevant to
Registry conditions: Maxillary Transverse Deficiency Class I Malocclusion Vitamin D Deficiency Orthodontic Tooth Movement Adolescent Health. Basic parameters: 16 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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.

Interventions

  • 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 an

Primary outcome measures

  • Change in Intermolar and Intercanine Widths After MARPE Treatment [Time frame: At baseline (T1) and after expansion phase (T2), approximately 6 weeks apart]
Secondary outcome measures (1)
  • Change in Serum Vitamin D Levels [Time frame: Baseline (T1) and Post-treatment at Week 8 (T2)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Faculty Of Dentistry — Konya

Publications

  • 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

Identifiers

NCT: NCT06943443 · 2025550

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗