NCT07591948

Brief Summary

Orthodontic treatment is a common and effective approach to correcting dental malocclusions and improving oral function and aesthetics. The process involves applying mechanical forces to move teeth into their desired positions, which can lead to discomfort and pain for patients, especially during the initial stages of treatment. While the ultimate goal of orthodontic therapy is to achieve proper alignment, the associated pain and the time required to complete the treatment often become significant concerns for patients. (Jheon et al., 2017). The duration of treatment, which typically spans several months or even years, is influenced by various factors including the type of malocclusion, the force applied, and the biological response of the periodontal tissues to the applied forces. (Sangle et al., 2023). Recent advancements in orthodontic care have focused on finding ways to accelerate tooth movement while minimizing the discomfort experienced by patients. Low-level laser therapy (LLLT), also known as photobiomodulation (PBM), has garnered significant attention as a non-invasive method to enhance biological healing processes. LLLT has been shown to stimulate cellular activity, increase collagen production, and improve blood circulation, potentially influencing the rate of tooth movement (Fini et al., 2020). Several studies suggest that LLLT may enhance the osteoclast and osteoblast activity in the periodontal tissues, leading to more rapid bone resorption and apposition, which could expedite the tooth movement process (Suzuki et al., 2016). Additionally, LLLT has been shown to reduce pain perception, possibly by modulating nerve activity and inflammation (Guo et al., 2021).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

June 2, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2028

Last Updated

May 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 25, 2026

Last Update Submit

May 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • tooth movement measurement

    Tooth Movement Measurement • Method: Cephalometric radiographs will be taken at baseline, 4 weeks, and 8 weeks to assess tooth movement. Linear measurements will be made between specific cephalometric landmarks by a calibrated and blinded examiner using digital imaging software. • Parameters: The distance between the canine and second premolar is measured at baseline and at monthly intervals until the end of the study. • Tool: Digital calipers and specialized software (e.g., OrthoAnalyzer) are used for precise measurements (Ren et al., 2003).

    Tooth Movement Measurement • Method: Cephalometric radiographs will be taken at baseline, 4 weeks, and 8 weeks to assess tooth movement. Linear measurements will be made between specific cephalometric landmarks by a calibrated and blinded examiner using

Secondary Outcomes (1)

  • pain assessment

    Timing: Pain is assessed at baseline (before treatment) and at 6 hours, 24 hours, 3 days, 7 days, and 14 days after the application of orthodontic force and LLLT/sham irr

Study Arms (2)

The control group

SHAM COMPARATOR

The control group will receive a sham laser treatment using the same device and procedure as the LLLT group, but without emitting the laser beam. Both the patients and the operator will be blinded to the treatment allocation

Procedure: Low level laser therapy

Laser therapy group

ACTIVE COMPARATOR

The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm

Procedure: Low level laser therapy

Interventions

All participants will receive standard orthodontic treatment using appliances. The type of tooth movement studied will include, (e.g., canine retraction, molar distalization). Orthodontic adjustments will be performed at intervals (e.g., every 4 weeks) by a single calibrated orthodontist to ensure consistency of force application. Force magnitude will be monitored using (e.g., strain gauges, force measuring devices) at each adjustment The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm. The laser parameters will be as follows: Participants receive low-level laser therapy in addition to standard orthodontic treatment. • The laser device used is a Ga-As-Al diode laser with a wavelength of 810 nm, power output of 100 mW, and energy density of 5 J/cm² (Sousa et al., 2011). • Laser application is performed at specific time points: immediately after bracket placement, on days 3, 7, and 14, and then monthly until the end of the study.

Also known as: orthodontic
Laser therapy groupThe control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 15-30 years requiring fixed orthodontic treatment.
  • Extraction treatment plan with bilateral canine retraction.
  • Good oral hygiene and periodontal health.
  • No systemic diseases or medications affecting bone metabolism.

You may not qualify if:

  • Previous orthodontic treatment.
  • Smoking or alcohol consumption.
  • Pregnancy or lactation.
  • Use of analgesics or anti-inflammatory drugs during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
This study will be a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of low-level laser therapy (LLLT) on accelerating orthodontic tooth movement (OTM) and pain reduction. The study will be conducted in accordance
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2026

First Posted

May 18, 2026

Study Start (Estimated)

June 2, 2026

Primary Completion (Estimated)

February 2, 2028

Study Completion (Estimated)

February 2, 2028

Last Updated

May 18, 2026

Record last verified: 2026-03