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Not yet recruitingNCT07299552Updated Dec 23, 2025

Effects of Vitamin D in Patients Undergoing Fixed Orthodontic Mechanotherapy

An interventional study of Vitamin D (Calcitriol) and Placebo in Malocclusions, sponsored by Hospital Universiti Sains Malaysia. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by Hospital Universiti Sains Malaysia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

The goal of this interventional research is to determine the impact of vitamin D intake on substances in saliva, pain, tooth movement, and the density of the bone around teeth in patients during orthodontic treatment. It will compare the effects of vitamin D supplementation with a placebo to clarify its role in the aforementioned aspects of orthodontic care. The main questions it aims to answer are:

How does vitamin D supplementation affect salivary opiorphin levels in patients undergoing fixed orthodontic mechanotherapy at Specialist Hospital Universiti Sains Malaysia? What is the impact of vitamin D supplementation on pain perception during fixed orthodontic mechanotherapy? How does vitamin D supplementation influence the rate and quality of tooth movement in patients undergoing fixed orthodontic mechanotherapy? What is the relationship between salivary opiorphin levels and pain perception in patients supplemented with vitamin D during fixed orthodontic mechanotherapy? How does vitamin D supplementation affect changes in alveolar bone density during fixed orthodontic mechanotherapy? Researchers will provide vitamin D to the experimental group while the control group receives a placebo to see if vitamin D intake has an impact on substances in saliva, pain, tooth movement, and the density of the bone around teeth during orthodontic treatment.

Participants will:

Take vitamin D or a placebo every day for 4 months Visit the clinic once every 4 weeks for checkups and tests Participate in the study for a duration of up to 4 months

02

Conditions studied

  • Malocclusions

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03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 48 is above the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Hospital Universiti Sains Malaysia is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age Range: 18 to 35 years old. This age group is common and suitable for orthodontic treatment. During this period, skeletal remodeling is active, which is conducive to observing tooth movement and related physiological changes. It is also a stage where the regulatory effects of vitamin D on growth, development, and physiological functions are more pronounced.
  2. Orthodontic Requirement: Patients diagnosed with Class I malocclusion with extraction of all first premolars in both upper and lower arches, using MBT orthodontic brackets,and recruited from multiple operators.
  3. Health Status: Patients should be in good general health, without endocrine system diseases that affect calcium and phosphorus metabolism and bone metabolism (such as hyperthyroidism or hypothyroidism, parathyroid diseases, etc.). They should also have no severe liver or kidney diseases (since abnormal liver and kidney functions can interfere with the activation and metabolism of vitamin D), and no diseases (as autoimmune abnormalities may affect the inflammatory response and tissue repair mechanisms, thus interfering with the experimental results).
  4. Medication History: Patients who have not taken any medications affecting calcium and phosphorus metabolism (such as bisphosphonates), bone metabolism (such as recombinant human growth hormone or other drugs that promote or inhibit bone growth), and pain perception (such as long-term use of opioid analgesics, antidepressants that affect neurotransmitters) within the past three months are eligible. This ensures that the experiment is not interfered with by external drug factors.

Exclusion criteria

Exclusion Criteria:

  1. Oral Local Problems: Patients with uncontrolled acute or chronic oral inflammations are excluded, such as the acute stage of pericoronitis of wisdom teeth, severe gingivitis, or periodontitis in the progressive and destructive stage. Such inflammations can interfere with the reaction of orthodontic teeth to force and pain assessment. Those with oral mucosal lesions that affect the comfort of wearing orthodontic appliances and the stability of the oral microenvironment are also excluded.
  2. Systemic Diseases: Besides the aforementioned endocrine, liver and kidney, and diseases, patients with severe cardiovascular diseases (who may have difficulty tolerating the stimulation of orthodontic force application and the regular follow-up process), hematological diseases (which affect blood coagulation and tissue repair and increase the risks of orthodontic treatment), malignant tumors (undergoing radiotherapy or chemotherapy that affects systemic metabolism and immunity) are also excluded. These systemic diseases will introduce too many complex variables and affect the observation of the single factor effect of vitamin D.
  3. Special Physiological Periods or Conditions: Pregnant or lactating women are excluded because of the significant fluctuations in hormones and the special nutritional requirements of the fetus or infant, which change the pattern of calcium and phosphorus metabolism. Patients with a recent history of major traumas such as fractures, whose bodies are in a critical period of trauma repair and bone metabolism is in a special stress state, are also not suitable for this experiment as it may interfere with the study of normal orthodontic bone remodeling.
  4. Poor Compliance: Patients who cannot be guaranteed regular follow-ups, take medications as prescribed, and cooperate with various examinations are excluded. For example, those with mental or psychological disorders that make it difficult to follow the medical plan, or those who are highly mobile and unable to maintain stable and continuous treatment and observation. Excluding such patients ensures the integrity and reliability of experimental data and the smooth progress of the experimental process.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Vitamin D Group

    Participants receive a 1000 IU vitamin D tablet daily for 4 months during orthodontic treatment.

    Dietary Supplement: Vitamin D (Calcitriol)

  • Placebo comparator
    Placebo Group

    Participants receive a placebo (without vitamin D) daily for 4 months during orthodontic treatment.

    Other: Placebo

Interventions

  • Dietary supplementVitamin D (Calcitriol)

    Participants receive a 1000 IU vitamin D tablet daily for 4 months during orthodontic treatment. The supplement is provided in tablet form to participants in the experimental group.

  • OtherPlacebo

    Oral administration of a placebo (look-alike substance without active vitamin D ingredient), taken daily for 4 months during fixed orthodontic mechanotherapy. The placebo is formulated to match the appearance (e.g., shape, color) and dosage form of the vitamin D supplement provided to the experimental group.

06

What researchers measure

Primary outcomes

  1. Salivary Opiorphin Levels During Fixed Orthodontic Mechanotherapy

    Quantify salivary opiorphin concentrations using Human Opiorphin enzyme-linked immunosorbent assay(ELISA) Kit (unit: ng/mL)to evaluate changes associated with vitamin D supplementation.

    Time frame: Baseline assessment, followed by checkups every four weeks over the 4-month period

  2. Pain Perception During Fixed Orthodontic Mechanotherapy

    Assess pain intensity and frequency using a validated pain rating scale (e.g., visual analog scale) to determine the effect of vitamin D supplementation.Visual analog scale(VAS) is a validated, self-reported instrument assessing average pain intensity,Possible scores range from 0 (no pain) to 10 (worst possible pain). A clinically significant difference was considered to be a change by 3 points.

    Time frame: Baseline assessment, followed by checkups every four weeks over the 4-month period

  3. Rate of Tooth Movement During Fixed Orthodontic Mechanotherapy

    Measure tooth movement parameters (i.e., Little's Irregularity Index,unit: millimetres \[mm\]) via intraoral scan models to evaluate the influence of vitamin D supplementation.

    Time frame: Baseline assessment, followed by checkups every four weeks over the 4-month period

  4. Analyze the relationship between salivary opiorphin levels and pain perception in patients supplemented with vitamin D during fixed orthodontic mechanotherapy.

    Analyze the correlation between salivary opiorphin levels (unit: ng/mL; measurement tool: enzyme-linked immunosorbent assay \[ELISA\]) and pain perception (unit: score, 0-10; measurement tool: 100-mm visual analog scale \[VAS\]) in patients supplemented with vitamin D during fixed orthodontic mechanotherapy.

    Time frame: through study completion, an average of 1 year

  5. Evaluate the effects of vitamin D supplementation on changes in alveolar bone density during fixed orthodontic mechanotherapy.

    Cone Beam Computed Tomography (CBCT) will be conducted to assess baseline alveolar bone density on the buccal, lingual, mesial, and distal aspects of tooth roots, as well as in specific jaw regions (e.g., condyle, mandibular angle, maxillary sinus floor).

    Time frame: Baseline assessment, followed by a final checkup at the end of the 4-month period

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07299552
Lead sponsor
Hospital Universiti Sains Malaysia
Responsible party
Gao Lu (Doctor, Hospital Universiti Sains Malaysia) — Principal investigator
First posted
Dec 23, 2025
Start date
Dec 30, 2025 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Dec 23, 2025

Study contacts

GAO LU
Contact
gaolu@student.usm.my
+601153720120

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Vitamin D

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