- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07591948
The Effect of Low-Level Laser Therapy on Accelerating Tooth Movement and Reducing Pain During Orthodontic Treatment (LLLT)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Previous orthodontic treatment.
- Smoking or alcohol consumption.
- Pregnancy or lactation.
- Use of analgesics or anti-inflammatory drugs during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: The control group
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
|
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.
Other Names:
|
|
Active Comparator: Laser therapy group
The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tooth movement measurement
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain assessment
Time Frame: 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
|
Pain Assessment • Tool: Visual Analog Scale (VAS) is used to measure pain levels.
• 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 irradiation.
• Procedure: Participants mark their pain level on a 10 cm line, where 0 indicates no pain and 10 indicates the worst pain imaginable
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- (OR:06/05/2025)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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