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

NCT07286474 | Active Not Recruiting

• 1 other identifier: USM/JEPeM/KK/24040356
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Malocclusion of Anterior Teeth

Keywords

LLLT, vitamin D3 supplements, randomized controlled trial, mandibular crowding, root resorption, pain perception, acceleration of orthodontics

Outcome Measures

Primary Outcomes (1)

• Rate of Orthodontic Tooth Movement

  The rate of reduction in mandibular anterior crowding, measured in mm/month using Little's Irregularity Index (sum of linear displacements between contact points of the six mandibular anterior teeth from canine to canine, assessed via dental models). Compared across groups to evaluate acceleration effects.

  From baseline (initiation of alignment) to complete alignment (Little's Irregularity Index reaches 0 mm), assessed every 4 weeks (estimated duration 6-10 months per participant)

Secondary Outcomes (3)

• Root Resorption

  Baseline and at completion of alignment (estimated 6-10 months)

• Pain Perception

  Daily for 7 days after each monthly visit, throughout the alignment phase (up to 10 months)

• Duration of Orthodontic Alignment

  From baseline to complete alignment, monitored every 4 weeks (estimated 6-10 months)

Study Arms (3)

Vitamin D3 Only Group

EXPERIMENTAL

Participants receive standard orthodontic treatment with pre-adjusted edgewise brackets (0.022" MBT prescription) and wire sequencing (0.014" NiTi initial, progressing to 0.017x0.025" SS). Additionally, oral Vitamin D3 supplementation: single loading dose of 50,000 IU one week before treatment, followed by 1,000 IU daily maintenance until alignment completion. No LLLT.

Dietary Supplement: Cholecalciferol (Vit D3); Device: Fixed Orthodontic Appliance

Vitamin D3 + LLLT Group

EXPERIMENTAL

Participants receive standard orthodontic treatment as above. Plus oral Vitamin D3 supplementation (50,000 IU loading one week before, 1,000 IU daily). Plus LLLT using InGaAlAs diode laser (940 nm, 2.5 W, 25.7 J/cm², 30 seconds labially at muco-gingival junction) initiated at alignment start, repeated on days 14 and 30, then every 4 weeks until completion.

Dietary Supplement: Cholecalciferol (Vit D3); Radiation: Low-Level Laser Therapy

Control Group

ACTIVE COMPARATOR

Participants receive only standard orthodontic treatment with pre-adjusted edgewise brackets (0.022" MBT prescription) and wire sequencing (0.014" NiTi initial, progressing to 0.017x0.025" SS). No Vitamin D3 supplementation or LLLT.

Device: Fixed Orthodontic Appliance

Interventions

Cholecalciferol (Vit D3) DIETARY_SUPPLEMENT

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.

Vitamin D3 + LLLT Group; Vitamin D3 Only Group

Low-Level Laser Therapy RADIATION

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.

Vitamin D3 + LLLT Group

Fixed Orthodontic Appliance DEVICE

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.

Control Group; Vitamin D3 Only Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants requiring orthodontic treatment for crowding in the range of 4 to 8 mm in the lower anterior segment.
• Age range: 18 to 40 years.
• Angles Class I, II or III malocclusion
• Fully erupted permanent dentition
• Good oral and general health
• \- Normal range of Vitamin D levels

You may not qualify if:

• Deficiency of Vitamin D levels below normal range. • Medically compromised patients with thyroid, parathyroid, or renal and liver diseases.
• Patients on medication, especially corticosteroid and anticonvulsant drugs • Poor oral hygiene
• Pregnancy
• Lactation
• History of craniofacial abnormalities or syndromes that may affect orthodontic tooth movements.
• Participants failing to complete the Vitamin D supplementation log sheets will be excluded to ensure accurate data collection.
• Inability to comply with the study protocol or unable to complete the study due to personal, medical, or logistical reasons (e.g., missed follow-up visits or failure to undergo assessments) will be excluded to maintain data integrity and minimize biases from incomplete participation.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Armed Forces Hospital

Madinah, Madinah, 42314, Saudi Arabia

Location

MeSH Terms

Conditions

Root Resorption

Interventions

Cholecalciferol; Low-Level Light Therapy; Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Tooth Resorption; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Laser Therapy; Therapeutics; Phototherapy; Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Rozita Hassan, BDS, MS, MOrtho RCSEd

  Universiti Sains Malayisa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: The three study arms in this randomized controlled trial are as follows: * Group 1A (Experimental): Standard orthodontic treatment (braces) plus oral Vitamin D3 supplements (initial 50,000 IU dose one week before treatment, followed by 1,000 IU daily maintenance). * Group 1B (Experimental): Standard orthodontic treatment (braces) plus oral Vitamin D3 supplements (as above) combined with Low-Level Laser Therapy (LLLT) applied to the gums at specified intervals. * Control Group: Standard orthodontic treatment (braces) only, with no Vitamin D3 supplements or LLLT.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)