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
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
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 →Hospital Universiti Sains Malaysia is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a 1000 IU vitamin D tablet daily for 4 months during orthodontic treatment.
Dietary Supplement: Vitamin D (Calcitriol)
Participants receive a placebo (without vitamin D) daily for 4 months during orthodontic treatment.
Other: Placebo
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.
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.
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
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
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
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
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
Plan to share: No
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Studies of the drug tested here: Vitamin D
Hospital Universiti Sains Malaysia