Effect of Serum Vitamin D on MARPE Treatment Response

NCT ID: NCT06943443

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2025-11-25

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group MARPE Treatment with Vitamin D Supplementation

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.

Group Type: EXPERIMENTAL

Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Konya Necmettin Erbakan Üniversitesi

OTHER

Sponsor Role: lead

Responsible Party

KAZIM KAAN YILDIZ

Principal Investigator/ Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty Of Dentistry

Konya, Meram, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 35198025 (View on PubMed)

Other Identifiers

2025550

Identifier Type: -

Identifier Source: org_study_id