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RECRUITING
NCT07286474
NA

Effects of Laser Therapy and Vitamin D Pills on Braces Tooth Movement: A Random Controlled Study

Sponsor: Universiti Sains Malaysia

View on ClinicalTrials.gov

Summary

This clinical trial aims to evaluate the efficacy of low-level laser therapy (LLLT) in conjunction with oral vitamin D3 supplementation in accelerating orthodontic tooth movement in adults with crowded mandibular anterior teeth undergoing orthodontic treatment. Additionally, the study seeks to assess the safety profile and potential adverse effects, including pain and root resorption. The primary research questions are as follows: 1. Does vitamin D3 enhance the rate of orthodontic tooth movement? 2. Does the combination of vitamin D3 and LLLT result in a greater acceleration of tooth movement compared to either intervention alone? 3. Do vitamin D3 and LLLT influence the extent of root resorption? 4. Do vitamin D3 and LLLT mitigate pain associated with orthodontic treatment? 5. Do vitamin D3 and LLLT reduce the frequency of required clinical visits? The study will compare the outcomes of orthodontic treatment with braces alone, braces with vitamin D3 supplementation, and braces with both vitamin D3 and LLLT, to determine their effects on the rate of tooth movement, pain reduction, and root resorption. Participants will undergo the following procedures: * A blood test to assess baseline vitamin D levels. * Placement of orthodontic braces. * Daily administration of vitamin D3 supplements for those assigned to the relevant groups, commencing with a loading dose one week prior to the initiation of orthodontic treatment. * Application of LLLT to the gingival tissues for participants in the corresponding group, administered at the start and during follow-up visits. * Regular clinic visits every four weeks for monitoring, pain assessment, and measurement of tooth movement until the completion of orthodontic alignment.

Official title: The Effects of Combined Low-Level Laser Therapy (LLLT) and Oral Vitamin D3 Supplements on Orthodontic Tooth Movements: A Randomized Controlled Trial.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-01-01

Completion Date

2026-12-31

Last Updated

2025-12-16

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol (Vit D3)

Oral cholecalciferol supplementation: initial loading dose of 50,000 IU one week before orthodontic treatment initiation, followed by daily maintenance dose of 1,000 IU until alignment completion. Administered to participants with baseline sufficient Vitamin D levels.

RADIATION

Low-Level Laser Therapy

Diode laser (Biolase 10W 940±10nm, InGaAlAs) with tooth whitening handpiece (spot size 2.8 cm²), wavelength 940 nm, power output 2.5 W, energy density 25.7 J/cm², continuous wave mode. Applied labially in direct contact at mucogingival junction for 30 seconds. Initiated at alignment start, repeated on days 14 and 30, then every 4 weeks until completion. Eye protection worn by operator and participant.

DEVICE

Fixed Orthodontic Appliance

Pre-adjusted edgewise conventional brackets with 0.022" MBT (McLaughlin Bennett Trevisi) prescription (3M Unitek), bondable 0.022" single slot molar tubes, bonded using Transbond XT light cure material on upper and lower arches. Wire sequencing: initial 0.014" super elastic nickel-titanium (SE-NiTi), followed by 0.016" SE-NiTi, 0.016 x 0.022" SE-NiTi, and finally 0.017 x 0.025" stainless steel wire until alignment completion. Adjustments every 4 weeks.

Locations (1)

Armed Forces Hospital

Madinah, Madinah, Saudi Arabia