MalocclusionsNCT07299552
Effects of Vitamin D in Patients Undergoing Fixed Orthodontic Mechanotherapy
A study testing Vitamin D (Calcitriol) in people with Malocclusions, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Malocclusions
- What is being tested?
- Vitamin D (Calcitriol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Dec 2025to 1 Jan 2027
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Systemic Diseases: Besides the aforementioned endocrine, liver and kidney, and autoimmune 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Hospital Pakar Universiti Sains Malaysia
Kota Bharu, Kelantan, 15200
GAO LU, 01153720120, gaolu@student.usm.my
About this study
Official title: Effects of Vitamin D on Salivary Opiorphin Level, Pain Perception and Tooth Movement in Patients Undergoing Fixed Orthodontic Mechanotherapy
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.
Read more
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
- Conditions
- Malocclusions
- Being tested
- Vitamin D (Calcitriol), Placebo
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (Calcitriol)Dietary supplement
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Group | Experimental | Participants receive a 1000 IU vitamin D tablet daily for 4 months during orthodontic treatment. Receives: Dietary Supplement: Vitamin D (Calcitriol) |
| Placebo Group | Placebo comparator | Participants receive a placebo (without vitamin D) daily for 4 months during orthodontic treatment. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment, followed by checkups every four weeks over the 4-month period
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.
Measured: Baseline assessment, followed by checkups every four weeks over the 4-month period
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: Baseline assessment, followed by a final checkup at the end of the 4-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionsStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Lu, Hospital Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299552
- Sponsor's protocol ID
- USM/JEPeM/KK/25030319
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D on Salivary Opiorphin Level, Pain Perception and Tooth Movement in Patients Undergoing Fixed Orthodontic Mechanotherapy
- ClinicalTrials.gov ID
- NCT07299552
- Acronym / sponsor ID
- USM/JEPeM/KK/25030319
- Conditions
- Malocclusions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 Dec 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Group | Experimental | Dietary Supplement: Vitamin D (Calcitriol)Participants receive a 1000 IU vitamin D tablet daily for 4 months during orthodontic treatment. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants receive a placebo (without vitamin D) daily for 4 months during orthodontic treatment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- Systemic Diseases: Besides the aforementioned endocrine, liver and kidney, and autoimmune 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.
- 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.
- 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.
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 |
|---|---|---|
| Vitamin 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. | Dietary supplement | Vitamin D Group |
| PlaceboOral 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. | Other | Placebo Group |
Primary outcome
Salivary Opiorphin Levels During Fixed Orthodontic Mechanotherapy
Time frame: Baseline assessment, followed by checkups every four weeks over the 4-month period
Quantify salivary opiorphin concentrations using Human Opiorphin enzyme-linked immunosorbent assay(ELISA) Kit （unit: ng/mL）to evaluate changes associated with vitamin D supplementation.
Pain Perception During Fixed Orthodontic Mechanotherapy
Time frame: Baseline assessment, followed by checkups every four weeks over the 4-month period
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.
Rate of Tooth Movement During Fixed Orthodontic Mechanotherapy
Time frame: Baseline assessment, followed by checkups every four weeks over the 4-month period
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.
Analyze the relationship between salivary opiorphin levels and pain perception in patients supplemented with vitamin D during fixed orthodontic mechanotherapy.
Time frame: through study completion, an average of 1 year
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.
Evaluate the effects of vitamin D supplementation on changes in alveolar bone density during fixed orthodontic mechanotherapy.
Time frame: Baseline assessment, followed by a final checkup at the end of the 4-month period
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).
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 23 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Malocclusions
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (Calcitriol) in people with Malocclusions, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 23 Dec 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
Contact GAO LU (+601153720120, gaolu@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Opiorphin Levels During Fixed Orthodontic Mechanotherapy (time frame: Baseline assessment, followed by checkups every four weeks over the 4-month period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025.