Enrolling by Invitation

NCT Number: NCT06943443

Effect of Serum Vitamin D on MARPE Treatment Response

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.

Enrolling by Invitation

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Key information

Conditions

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

Age range

16 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Of Dentistry

Konya, Meram, 42090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Change in Intermolar and Intercanine Widths After MARPE Treatment

Time frame: 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.

Secondary outcomes

Change in Serum Vitamin D Levels

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

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.

Sponsors and collaborators

Lead sponsor

Konya Necmettin Erbakan Üniversitesi

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Apr 24, 2025
Registry last updated: Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.