Photobiomodulation Effect on Vietnamese Orthodontic Patients

NCT ID: NCT07276984

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2025-10-10

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.

Detailed Description

During the orthodontic treatment period, patients must endure various discomforts, such as the risk of inflammatory root resorption and frequent pain, which typically occur due to the body's inflammatory response to the applied forces. Pain is commonly managed with non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen; however, these medications may induce adverse effects and potentially inhibit tooth movement. Photobiomodulation (PBM) therapy using light-emitting diodes (LEDs) has emerged as a non-pharmacological approach that may reduce pain, enhance tooth movement, and lower the risk of root resorption.

The objective of this randomized, placebo-controlled clinical trial is to evaluate the effects of LED PBM on pain reduction, enhancement of tooth movement, and mitigation of root resorption risk during orthodontic treatment. Sixteen participants aged 11 to 30 years undergoing fixed orthodontic treatment were randomly assigned to either the intervention group or the placebo group. In the intervention group, patients used the LED device for 10 minutes per day (5 minutes for the upper arch and 5 minutes for the lower arch) every day. In the placebo group, patients used a sham LED device (without a charging case) following the same procedure, 10 minutes per day. Patients in both groups were blinded to the light status while wearing the device. After finishing the aligning and leveling stage with Nickel and Titanium (NiTi) arch wires, during the phase of canine distalization with stainless steel arch wires, patients were assessed at four consecutive follow-up visits, scheduled at monthly intervals.

Canine movement was measured by superimposing sequential 3D digital scans obtained over these four visits using 3D Slicer software. Saliva and gingival crevicular fluid (GCF) samples were collected at each follow-up visit to measure dentin sialoprotein (DSP), a biomarker of root resorption in humans. Additionally, at each visit, patients' 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. The primary outcomes are differences between groups in canine displacement, pain intensity, and DSP concentration in both saliva and GCF.

The findings of this study may support the clinical application of LED PBM as a safe, non-invasive, and drug-free adjunctive therapy to improve patient comfort and reduce treatment-related risks during orthodontic care, particularly in Vietnamese patients.

Conditions

Pain Management; Root Resorption; Orthodontic; Tooth Movement

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sham LED device

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.

Group Type: PLACEBO_COMPARATOR

Placebo LED device

Intervention Type: DEVICE

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

850nm LED device

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.

Group Type: EXPERIMENTAL

LED device

Intervention Type: DEVICE

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

Interventions

LED device

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

Intervention Type: DEVICE

Placebo LED device

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role: lead

Responsible Party

Thanh Thuy-Nhat Cao

Principal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thanh TN Cao, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Pharmacy in Ho Chi Minh city

Locations

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

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Other Identifiers

22230-DHYD

Identifier Type: -

Identifier Source: org_study_id