NCT07810699

Brief Summary

This study aims to compare the effects of diode laser and light-emitting diode (LED) photobiomodulation on maxillary canine retraction during fixed orthodontic treatment. Participants requiring bilateral maxillary first premolar extraction will receive both interventions using a split-mouth design. One maxillary canine will receive diode laser photobiomodulation, while the contralateral maxillary canine will receive LED photobiomodulation. Maxillary canine movement will be evaluated at 4, 8, 12, and 16 weeks during retraction to compare the amount and rate of tooth movement between the two interventions. Pain associated with orthodontic tooth movement will also be assessed. Pulp oxygen saturation (SpO₂) of the maxillary canines will be measured to evaluate changes in pulpal oxygenation during orthodontic canine retraction. SpO₂ will be assessed at baseline and at predefined follow-up time points, including 20 minutes, 24 hours, 7 days, and 4 weeks. Changes in SpO₂ will be compared between the diode laser and LED sides. Cone-beam computed tomography (CBCT) will be used to evaluate changes in maxillary canine root length and alveolar bone dimensions before and after canine retraction. The study is expected to determine whether diode laser and LED photobiomodulation differ in their effects on orthodontic canine retraction, pulpal oxygenation, pain, and associated dental and alveolar bone changes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
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

Study Progress50%
Jan 2026Jul 2027

Study Start

First participant enrolled

January 3, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 2, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

Orthodontic tooth movementPhotobiomodulationDiode laserLight-emitting diodeSpO₂

Outcome Measures

Primary Outcomes (1)

  • Amount of Maxillary Canine Retraction

    The amount of maxillary canine retraction will be measured in millimeters using digital intraoral scans. Canine movement will be assessed by comparing the position of the maxillary canine at baseline and at each follow-up time point. The amount of retraction on the diode laser side will be compared with that on the contralateral LED side within the same participant.

    Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Secondary Outcomes (4)

  • Pain Intensity Following Orthodontic Canine Retraction

    1 day, 3 days, and 7 days after photobiomodulation

  • Change in Maxillary Canine Root Length

    Baseline and 16 weeks

  • Change in Alveolar Bone Dimensions Around the Maxillary Canine

    Baseline and 16 weeks

  • Change in Pulp Oxygen Saturation of the Maxillary Canine

    Baseline, 20 minutes, 24 hours, 7 days, and 4 weeks after initiation of canine retraction.

Study Arms (2)

Diode Laser

EXPERIMENTAL

The maxillary canine allocated to the diode laser side will receive diode laser photobiomodulation during orthodontic canine retraction. Photobiomodulation will be applied according to the study protocol and repeated at 4-week intervals during the 16-week observation period.

Device: Diode Laser Photobiomodulation

LED

ACTIVE COMPARATOR

The contralateral maxillary canine allocated to the LED side will receive light-emitting diode (LED) photobiomodulation during orthodontic canine retraction. Photobiomodulation will be applied according to the study protocol and repeated at 4-week intervals during the 16-week observation period.

Device: LED Photobiomodulation

Interventions

The contralateral maxillary canine will receive light-emitting diode (LED) photobiomodulation during orthodontic canine retraction. LED irradiation will be applied at 12 points around the canine root, including six points on the buccal side and six points on the palatal side. The LED will be applied for 5 seconds at each point, with an energy density of 6 J/cm² and a wavelength range of 430-480 nm. The intervention will be repeated at 4-week intervals during the 16-week canine retraction period.

LED

Diode laser photobiomodulation at a wavelength of 810 nm will be applied to the maxillary canine during orthodontic retraction. Irradiation will be delivered at 12 points around the canine root, including six points on the buccal side and six points on the palatal side. The root area will be divided into cervical, middle, and apical regions. The laser will be applied for 10 seconds per region, delivering 1 J per region and a total energy of 6 J per tooth. The energy density will be 5.1 J/cm². The intervention will be repeated at 4-week intervals during the 16-week canine retraction period.

Diode Laser

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with complete permanent dentition and cervical vertebral maturation at CS5 or CS6 according to the Baccetti classification.
  • Angle Class I malocclusion.
  • Indication for fixed orthodontic treatment requiring bilateral extraction of the maxillary first premolars.
  • Similar position, morphology, and dimensions of the maxillary canines on both sides.
  • No previous orthodontic treatment.
  • Willingness to participate in the study and provision of informed consent.

You may not qualify if:

  • Patients with bleeding or coagulation disorders, diabetes mellitus, bone diseases, or periodontal diseases.
  • Use of medications that may affect orthodontic tooth movement or coagulation, including aspirin, heparin, warfarin, nonsteroidal anti-inflammatory drugs, or glucocorticoids.
  • History of maxillofacial trauma or craniofacial anomalies.
  • Smoking.
  • Pregnancy.
  • Requirement for extraction of teeth other than the first premolars.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saigon Dental Clinic - Dr. Lam

Can Tho, CAN THO, Vietnam

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 9, 2026

Study Start

January 3, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations