NCT07390357

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

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 28, 2026

Last Update Submit

February 5, 2026

Conditions

Keywords

PhotobiomodulationOrthodonticsTooth Movement Acceleration

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

EXPERIMENTAL

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.

Device: 635-nm photobiomodulation

Sham photobiomodulation-treated side

PLACEBO COMPARATOR

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.

Device: Sham photobiomodulation

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.

Photobiomodulation-treated side

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.

Sham photobiomodulation-treated side

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Overbite

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

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

Locations