- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07390357
Effect of Photobiomodulation on Orthodontic Tooth Movement
Effect of 635-nm Photobiomodulation on Orthodontic Tooth Movement: a Randomized Split-mouth Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Wschowa, Poland, 67-400
- Ka-dent, Lipowa 18
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Photobiomodulation-treated side
One 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.
|
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.
|
|
Placebo Comparator: Sham photobiomodulation-treated side
The 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of maxillary canine tooth movement
Time Frame: Baseline (Day 0) to Day 45
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- WroclawMU8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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