Effect of Photobiomodulation on Orthodontic Tooth Movement
Effect of 635-nm Photobiomodulation on Orthodontic Tooth Movement: a Randomized Split-mouth Clinical Trial
1 other identifier
interventional
18
1 country
1
Brief Summary
This study evaluated whether photobiomodulation (PBM), a form of low-level light therapy, can accelerate orthodontic tooth movement during canine distalization in adult patients undergoing fixed orthodontic treatment. Eighteen adult patients requiring extraction of maxillary first premolars as part of orthodontic treatment for Class II malocclusion were enrolled. The study used a randomized, controlled, split-mouth design, in which one side of the maxilla was randomly assigned to receive PBM therapy, while the contralateral side served as an untreated control. This design allowed each participant to act as their own control. All patients underwent standard orthodontic treatment with fixed appliances and absolute anchorage provided by orthodontic mini-implants. Canine distalization was performed using nickel-titanium closed-coil springs delivering comparable orthodontic forces on both sides. Photobiomodulation was applied on the experimental side using a 635-nm diode laser according to a predefined schedule over a 45-day period, while no laser treatment was applied on the control side. The primary outcome was the amount of canine tooth movement, measured in millimeters at baseline and at follow-up visits using a calibrated orthodontic caliper. Tooth movement on the laser-treated side was compared with movement on the control side over time. The purpose of this study was to determine whether photobiomodulation could safely and effectively increase the rate of orthodontic tooth movement without additional surgical intervention or pharmacological treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
1 active site
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
Study Start
First participant enrolled
January 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2022
CompletedFirst Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 5, 2026
CompletedFebruary 10, 2026
January 1, 2026
9 months
January 28, 2026
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of maxillary canine tooth movement
The amount of orthodontic canine tooth movement was assessed by measuring the linear distance between the central points of the bracket slots bonded to the maxillary canine and first premolar. Measurements were performed using a calibrated orthodontic caliper at baseline (Day 0) and at follow-up visits up to Day 45. Tooth movement was calculated as the change in distance over time.
Baseline (Day 0) to Day 45
Study Arms (2)
Photobiomodulation-treated side
EXPERIMENTALOne side of the maxilla randomly assigned to receive photobiomodulation therapy during orthodontic canine distalization. This side received standard fixed orthodontic treatment with absolute anchorage provided by orthodontic mini-implants, combined with 635-nm photobiomodulation therapy applied according to the study protocol.
Sham photobiomodulation-treated side
PLACEBO COMPARATORThe contralateral side of the maxilla that served as the control. This side underwent the same orthodontic treatment protocol and mechanics as the experimental side. A sham photobiomodulation procedure was performed by placing the laser handpiece in contact with the tissues without light emission, simulating the intervention without delivering therapeutic laser energy.
Interventions
Photobiomodulation therapy delivered using a 635-nm diode laser in continuous wave mode. Laser irradiation was applied in contact mode to the post-extraction space and distal aspect of the canine root on the experimental side at predefined time points over a 45-day period.
A sham photobiomodulation procedure in which the laser handpiece was placed in contact with the tissues following the same schedule and application protocol as the experimental intervention, but without laser emission.
Eligibility Criteria
You may qualify if:
- Adults aged 18 years or older
- Class II malocclusion requiring extraction of maxillary first premolars
- Indication for maxillary canine distalization with absolute anchorage
- Fixed orthodontic treatment for the first time
- Good general health
- Non-smokers
- Good periodontal health
- Ability to understand the study procedures and provide written informed consent
You may not qualify if:
- Uncontrolled periodontal disease
- Systemic diseases or conditions affecting bone metabolism
- Diabetes mellitus or other metabolic disorders
- Pregnancy or breastfeeding
- History of radiotherapy or bisphosphonate therapy
- Use of systemic anti-inflammatory drugs or antibiotics within the previous 12 months
- Poor oral hygiene
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ka-dent, Lipowa 18
Wschowa, 67-400, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 5, 2026
Study Start
January 5, 2021
Primary Completion
October 10, 2021
Study Completion
July 27, 2022
Last Updated
February 10, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share