Pain ManagementNCT07276984
Photobiomodulation Effect on Vietnamese Orthodontic Patients
A study testing LED device in people with Pain Management and Root Resorption, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 30 years
- Conditions the study is for
- Pain Management, Root Resorption, Orthodontic
- What is being tested?
- LED device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Apr 2022to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Dentistry, University of Medicine and Pharmacy in Ho Chi Minh city
Ho Chi Minh City
About this study
Official title: Photobiomodulation Effect on Vietnamese Orthodontic Patients: A Randomized Clinical Trial
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.
Read the 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
- Being tested
- LED device, Placebo LED device
- Keywords
- photobiomodulation, pain, toothmovement, cumulative effect, LED, rootresoption
- Medical subject headings
- Agnosia, Root Resorption, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED deviceDevice
LED device emits near-infrared ligth at 850nm wavelength.
Placebo LED deviceDevice
Sham LED device contains no charging case (emiting no light)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: LED device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Immediately (0 hour) at Baseline, 1-month, 2-month, and 3-month follow-up visits.
Secondary outcomes (1)
Time to peak pain intensity
Time to peak pain intensity is defined as the time point (0 hour, 24 hours, or 48 hours) at which each participant records the highest Visual Analog Scale (VAS) score following initiation of canine distalization. Assessments will be performed at four scheduled visits: Baseline, 1-month, 2-month, and 3-month follow-up. The outcome will compare the proportion of participants whose peak pain occurs at each time point between the LED photobiomodulation group and the placebo group.
Measured: 0 hour, 24 hours, and 48 hours after treatment initiation at Baseline, 1-month, 2-month, and 3-month visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start20 Apr 2022
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanh Thuy-Nhat Cao, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Thanh TN Cao, MSc, Principal investigator, University of Medicine and Pharmacy in Ho Chi Minh city
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276984
- Sponsor's protocol ID
- 22230-DHYD
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of my primary outcomes including VAS scores of intervention and control groups
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Effect on Vietnamese Orthodontic Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07276984
- Acronym / sponsor ID
- 22230-DHYD
- Conditions
- Pain Management, Root Resorption, Orthodontic, Tooth Movement
- Keywords
- photobiomodulation, pain, toothmovement, cumulative effect, LED, rootresoption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham LED device | Placebo comparator | Device: Placebo LED devicePatients 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. |
| 850nm LED device | Experimental | Device: LED devicePatients 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. |
Who may qualify
- Ages
- 11 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LED deviceLED device emits near-infrared ligth at 850nm wavelength. | Device | 850nm LED device |
| Placebo LED deviceSham LED device contains no charging case (emiting no light) | Device | Sham LED device |
Primary outcome
Dentin sialoprotein (DSP) levels in saliva and gingival crevicular fluid
Time frame: Pre-treatment, Baseline, 1-month follow-up, and 2-month follow-up.
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.
Rate of canine distalization (mm/month) compared across monthly intervals
Time frame: Baseline to 1-month, 1-month to 2-month, and 2-month to 3-month 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
Change in pain intensity (VAS scores)
Time frame: Immediately (0 hour) at Baseline, 1-month, 2-month, and 3-month follow-up visits.
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
1 secondary outcome
Time to peak pain intensity
Time frame: 0 hour, 24 hours, and 48 hours after treatment initiation at Baseline, 1-month, 2-month, and 3-month visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Yes. The results of my primary outcomes including VAS scores of intervention and control groups
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanh TN Cao, MSc principal investigator
University of Medicine and Pharmacy in Ho Chi Minh city
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED device in people with Pain Management and Root Resorption, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin sialoprotein (DSP) levels in saliva and gingival crevicular fluid (time frame: Pre-treatment, Baseline, 1-month follow-up, and 2-month follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.