Not Yet RecruitingNot Applicable

Effects of Vitamin D in Patients Undergoing Fixed Orthodontic Mechanotherapy

Malaysia48 participantsStarted 2025-12-30

Plain-language 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

Who can participate

Age range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.
✓. 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 autoimmune diseases (as autoimmune abnormalities may affect the inflammatory response and tissue repair mechanisms, thus interfering with the experimental results).
✓. 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

What they're measuring

Salivary Opiorphin Levels During Fixed Orthodontic Mechanotherapy

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

Pain Perception During Fixed Orthodontic Mechanotherapy

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

Rate of Tooth Movement During Fixed Orthodontic Mechanotherapy

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

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

Timeframe: through study completion, an average of 1 year

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

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

Trial details

NCT IDNCT07299552

SponsorHospital Universiti Sains Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

GAO LU

+601153720120 gaolu@student.usm.my

View on ClinicalTrials.gov More Malocclusions trials

Plain-language summary

Who can participate

Age range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.
✓. 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 autoimmune diseases (as autoimmune abnormalities may affect the inflammatory response and tissue repair mechanisms, thus interfering with the experimental results).
✓. 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

What they're measuring

Salivary Opiorphin Levels During Fixed Orthodontic Mechanotherapy

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

Pain Perception During Fixed Orthodontic Mechanotherapy

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

Rate of Tooth Movement During Fixed Orthodontic Mechanotherapy

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

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

Timeframe: through study completion, an average of 1 year

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

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