Hospital Pakar Universiti Sains Malaysia
Kota Bharu, Kelantan, 15200, Malaysia
NCT Number: NCT07299552
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
Trial opening soon.
Get Notified18 year–35 year
All sexes
Interventional
Not applicable
Kota Bharu, Kelantan, 15200, Malaysia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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).
Contact information is provided by the study sponsor or research team.
Hospital Universiti Sains Malaysia
Other
Effects of Vitamin D on Salivary Opiorphin Level, Pain Perception and Tooth Movement in Patients Undergoing Fixed Orthodontic Mechanotherapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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