Maxillary Transverse Deficiency Class I Malocclusion Vitamin D Deficiency Orthodontic Tooth Movement Adolescent HealthNCT06943443
Effect of Serum Vitamin D on MARPE Treatment Response
A study testing Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment in people with Maxillary Transverse Deficiency Class I Malocclusion Vitamin D Deficiency Orthodontic Tooth Movement Adolescent Health, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Transverse Deficiency Class I Malocclusion Vitamin D Deficiency Orthodontic Tooth Movement Adolescent Health
- What is being tested?
- Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2025to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effects of Vitamin D Levels on Miniscrew-Assisted Rapid Palatal Expansion Treatment
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.
Read the 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.
- Being tested
- Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment
- Keywords
- Marpe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miniscrew-Assisted Rapid Palatal Expansion (MARPE) TreatmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (T1) and after expansion phase (T2), approximately 6 weeks apart
Secondary outcomes (1)
Change in Serum Vitamin D Levels
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.
Measured: Baseline (T1) and Post-treatment at Week 8 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start20 Feb 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary Transverse Deficiency Class I Malocclusion Vitamin D Deficiency Orthodontic Tooth Movement Adolescent HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KAZIM KAAN YILDIZ, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943443
- Sponsor's protocol ID
- 2025550
- Status last verified
- Aug 2025
- First submitted
- 14 Apr 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared in a de-identified format with other researchers, upon request, for further scientific investigation. The data sharing process will adhere to ethical guidelines and privacy laws to ensure participant confidentiality and security. All shared data will be anonymized, and no personally identifiable information will be included.
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.
PubMed 35198025
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Vitamin D Levels on Miniscrew-Assisted Rapid Palatal Expansion Treatment
- ClinicalTrials.gov ID
- NCT06943443
- Acronym / sponsor ID
- 2025550
- Keywords
- Marpe
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group MARPE Treatment with Vitamin D Supplementation | Experimental | Device: Miniscrew-Assisted Rapid Palatal Expansion (MARPE) TreatmentThis 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. |
| Control Group MARPE Treatment without Vitamin D Supplementation | Active comparator | Device: Miniscrew-Assisted Rapid Palatal Expansion (MARPE) TreatmentArm 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. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with systemic diseases
- Patients who smoke
- Patients with poor oral hygiene
- Patients with cooperation or compliance issues
- Patients with intellectual disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miniscrew-Assisted Rapid Palatal Expansion (MARPE) TreatmentVitamin 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 | Device | Control Group MARPE Treatment without Vitamin D Supplementation, Intervention Group MARPE Treatment with Vitamin D Supplementation |
Primary outcome
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.
1 secondary outcome
Change in Serum Vitamin D Levels
Time frame: Baseline (T1) and Post-treatment at Week 8 (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Results publication: PubMed 35198025Al-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.
- Individual participant dataSharing planned: Yes. Data will be shared in a de-identified format with other researchers, upon request, for further scientific investigation. The data sharing process will adhere to ethical guidelines and privacy laws to ensure participant confidentiality and security. All shared data will be anonymized, and no personally identifiable information will be included.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miniscrew-Assisted Rapid Palatal Expansion (MARPE) Treatment in people with Maxillary Transverse Deficiency Class I Malocclusion Vitamin D Deficiency Orthodontic Tooth Movement Adolescent Health, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intermolar and Intercanine Widths After MARPE Treatment (time frame: At baseline (T1) and after expansion phase (T2), approximately 6 weeks apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06943443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.