Photobiomodulation Effect on Vietnamese Orthodontic Patients

NCT07276984 | Completed DMC

• 1 other identifier: 22230-DHYD
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Since most orthodontic cases endure for 2 to 3 years or longer, patients are at a high risk of inflammatory root resorption and prolonged orthodontic pain, which is a common and unwanted side effect of their treatment. Photobiomodulation therapy utilizing light-emitting diodes (LEDs) offers a non-pharmacological approach for pain management, acceleration of tooth movement, and reduction of root resorption risk. This randomized, placebo-controlled clinical trial aims to evaluate the effects of LED photobiomodulation on pain alleviation, acceleration of tooth movement, and mitigation of root resorption risk during orthodontic treatment. A total of 16 Vietnamese participants, aged 11 to 30 years, receiving fixed orthodontic treatment were randomly assigned to either an intervention group (LED therapy) or a control group (placebo). Patients were assessed at four consecutive follow-up visits at monthly intervals. Canine movement was measured by superimposing patients' 3D scans collected at the four follow-ups in 3D Slicer. At each visit, their pain intensity was measured using the Visual Analog Scale (VAS) to establish the baseline for that follow-up (0 hour), and then measured again at 24 hours and 48 hours post-visit. Furthermore, during each visit, the investigator collected patients' saliva and gingival crevicular fluid (GCF) to extract dentin sialoprotein (DSP), a biomarker of root resorption in humans. The primary outcome is the difference in pain assessments between the intervention and control groups, the mobility of canines across groups, and the concentration of dentin sialoprotein in gingival crevicular fluid and saliva.

Conditions

Pain Management; Root Resorption; Orthodontic; Tooth Movement

Keywords

photobiomodulation; pain; toothmovement; cumulative effect; LED; rootresoption

Outcome Measures

Primary Outcomes (3)

• Dentin sialoprotein (DSP) levels in saliva and gingival crevicular fluid

  The primary endpoint is the difference in dentin sialoprotein (DSP) levels between the LED photobiomodulation group and the placebo group. DSP concentrations will be extracted from saliva and gingival crevicular fluid samples collected at four prespecified time points: * Pre-treatment * Baseline (initiation of canine distalization) * 1-month follow-up * 2-month follow-up DSP levels will be measured using Enzyme-Linked Immunosorbent Assay (ELISA). The primary comparison is the mean change in DSP levels across the follow-up period between the intervention and placebo groups, to evaluate the biomarker response associated with orthodontically induced inflammatory root resorption.

  Pre-treatment, Baseline, 1-month follow-up, and 2-month follow-up.

• Rate of canine distalization (mm/month) compared across monthly intervals

  Canine movement will be measured in millimeters by superimposing three-dimensional digital models of the maxilla and mandible. Digital models for participants in both study groups will be collected at the following visits: * Baseline (initiation of canine distalization) * 1-month follow-up * 2-month follow-up * 3-month follow-up Measurements will be performed using 3D Slicer software. The primary endpoint is the difference between the LED photobiomodulation group and the placebo group in the amount of canine movement observed during each monthly interval: * Baseline to 1-month * 1-month to 2-month * 2-month to 3-month

  Baseline to 1-month, 1-month to 2-month, and 2-month to 3-month intervals.

• Change in pain intensity (VAS scores)

  Pain intensity will be measured using a 100-mm Visual Analog Scale (VAS), illustrated as a 100mm ruler on questionnaire papers, where 0 represents no pain and 100 represents the worst imaginable pain. The primary endpoint is the difference in mean VAS scores between the LED photobiomodulation group and the placebo group. VAS scores will be recorded immediately at the time of each clinical visit. Measurements will be collected at four prespecified visits: * Baseline (initiation of canine distalization) * 1-month follow-up * 2-month follow-up * 3-month follow-up

  Immediately (0 hour) at Baseline, 1-month, 2-month, and 3-month follow-up visits.

Secondary Outcomes (1)

• Time to peak pain intensity

  0 hour, 24 hours, and 48 hours after treatment initiation at Baseline, 1-month, 2-month, and 3-month visits.

Study Arms (2)

Sham LED device

PLACEBO COMPARATOR

Patients wore the sham LED device without charging case for 10 minutes daily (5 minutes for the maxillary arch and 5 minutes for the mandibular arch at the same time each day). Patients did not know that LED device could emit light.

Device: Placebo LED device

850nm LED device

EXPERIMENTAL

Patients wore the LED device which emit near-infrared ligth at 850nm wavelength for 10 minutes daily (5 minutes for the maxillary arch and 5 minutes for the mandibular arch at the same time each day. Patients did not know that LED device could emit light.

Device: LED device

Interventions

LED device DEVICE

LED device emits near-infrared ligth at 850nm wavelength.

850nm LED device

Placebo LED device DEVICE

Sham LED device contains no charging case (emiting no light)

Sham LED device

Eligibility Criteria

• Age: 11 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 11-30 years old who were required to undergo extraction of four premolars for orthodontic purposes.
• Four canines erupted in both arches.
• No active caries, no gingivitis, or periodontal disease was diagnosed through clinical examination and panoramic X-ray.
• No history of previous orthodontic treatment.
• No abnormality in tooth shape, number, or size.

You may not qualify if:

• Patients who smoked, had systemic diseases, and/or were using medications that could affect pain sensation.
• Patients who are diagnosed with severe root resorption based on their panorama X-ray image.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Faculty of Dentistry, University of Medicine and Pharmacy in Ho Chi Minh city

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Agnosia; Root Resorption; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Resorption; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Thanh TN Cao, MSc

  University of Medicine and Pharmacy in Ho Chi Minh city

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 11, 2025
• Study Start: April 20, 2022
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start day: October 2025 End day: October 2027
• Access Criteria: Students and researchers. Through my email address, thanh.caothuynhat@gmail.com

Locations

VN (1)