Malocclusion Class INCT07810699
Diode Laser Versus LED for Maxillary Canine Retraction in Orthodontic Patients
A study testing Diode Laser Photobiomodulation and LED Photobiomodulation in people with Malocclusion Class I, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion Class I
- What is being tested?
- Diode Laser Photobiomodulation and LED Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteVietnam
- Study dates
- 3 Jan 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Saigon Dental Clinic - Dr. Lam
Can Tho, CAN THO
Lam Le, +84 918130809, lenguyenlam@ctump.edu.vn
About this study
Official title: Comparative Effects of Diode Laser and LED Photobiomodulation on Maxillary Canine Retraction During Orthodontic Treatment
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.
Read more
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.
Read the detailed description
This is an interventional split-mouth clinical study comparing diode laser and light-emitting diode (LED) photobiomodulation during maxillary canine retraction in patients undergoing fixed orthodontic treatment.
After alignment and leveling, maxillary canine retraction will be performed using standardized orthodontic mechanics. Each participant will receive both photobiomodulation interventions. One maxillary canine will receive diode laser photobiomodulation, while the contralateral maxillary canine will receive LED photobiomodulation according to the predefined side-allocation procedure. The interventions will be repeated at 4-week intervals during the 16-week observation period.
Digital intraoral scans will be obtained to quantify maxillary canine movement. Cumulative canine retraction will be assessed at 4, 8, 12, and 16 weeks. The amount and rate of canine retraction will be compared between the diode laser and LED sides within the same participant.
Pulp oxygen saturation (SpO₂) of the maxillary canines will be assessed to evaluate pulpal oxygenation during orthodontic tooth movement. SpO₂ measurements will be obtained separately from the canine receiving diode laser photobiomodulation and the contralateral canine receiving LED photobiomodulation at baseline, 20 minutes, 24 hours, 7 days, and 4 weeks after initiation of canine retraction. Changes from baseline and differences in SpO₂ between the two intervention sides will be evaluated.
Pain associated with orthodontic tooth movement will be assessed using a visual analog scale (VAS) after photobiomodulation. Cone-beam computed tomography (CBCT) examinations obtained before and after the canine retraction period will be used to evaluate changes in maxillary canine root length and alveolar bone dimensions.
Because both interventions are administered within the same participant, the split-mouth design allows direct within-participant comparison of diode laser and LED photobiomodulation while reducing the influence of interindividual biological variability.
- Conditions
- Malocclusion Class I
- Being tested
- Diode Laser Photobiomodulation, LED Photobiomodulation
- Keywords
- Orthodontic tooth movement, Photobiomodulation, Diode laser, Light-emitting diode, SpO₂
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode Laser PhotobiomodulationDevice
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.
LED PhotobiomodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: LED Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary outcomes (4)
Pain Intensity Following Orthodontic Canine Retraction
Pain intensity will be assessed using a Visual Analog Scale (VAS) following photobiomodulation during orthodontic canine retraction. Participants will record pain separately for the diode laser and LED sides. VAS scores will be compared between the two intervention sides.
Measured: 1 day, 3 days, and 7 days after photobiomodulation
Change in Maxillary Canine Root Length
Maxillary canine root length will be measured using cone-beam computed tomography (CBCT) to assess changes in root length associated with orthodontic canine retraction. Changes from baseline will be compared between the diode laser and LED sides.
Measured: Baseline and 16 weeks
Change in Alveolar Bone Dimensions Around the Maxillary Canine
Alveolar bone dimensions around the maxillary canine will be evaluated using cone-beam computed tomography (CBCT). Changes from baseline will be compared between the diode laser and LED sides.
Measured: Baseline and 16 weeks
Change in Pulp Oxygen Saturation of the Maxillary Canine
Pulp oxygen saturation (SpO₂) of the maxillary canines will be measured to evaluate changes in pulpal oxygenation during orthodontic canine retraction. SpO₂ values will be recorded separately for the maxillary canine receiving diode laser photobiomodulation and the contralateral maxillary canine receiving LED photobiomodulation. Changes from baseline and differences between the two intervention sides will be assessed.
Measured: Baseline, 20 minutes, 24 hours, 7 days, and 4 weeks after initiation of canine retraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start3 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion Class IStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810699
- Sponsor's protocol ID
- 26.442.HV
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Diode Laser and LED Photobiomodulation on Maxillary Canine Retraction During Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT07810699
- Acronym / sponsor ID
- 26.442.HV
- Conditions
- Malocclusion Class I
- Keywords
- Orthodontic tooth movement, Photobiomodulation, Diode laser, Light-emitting diode, SpO₂
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
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.
Detailed description
This is an interventional split-mouth clinical study comparing diode laser and light-emitting diode (LED) photobiomodulation during maxillary canine retraction in patients undergoing fixed orthodontic treatment.
After alignment and leveling, maxillary canine retraction will be performed using standardized orthodontic mechanics. Each participant will receive both photobiomodulation interventions. One maxillary canine will receive diode laser photobiomodulation, while the contralateral maxillary canine will receive LED photobiomodulation according to the predefined side-allocation procedure. The interventions will be repeated at 4-week intervals during the 16-week observation period.
Digital intraoral scans will be obtained to quantify maxillary canine movement. Cumulative canine retraction will be assessed at 4, 8, 12, and 16 weeks. The amount and rate of canine retraction will be compared between the diode laser and LED sides within the same participant.
Pulp oxygen saturation (SpO₂) of the maxillary canines will be assessed to evaluate pulpal oxygenation during orthodontic tooth movement. SpO₂ measurements will be obtained separately from the canine receiving diode laser photobiomodulation and the contralateral canine receiving LED photobiomodulation at baseline, 20 minutes, 24 hours, 7 days, and 4 weeks after initiation of canine retraction. Changes from baseline and differences in SpO₂ between the two intervention sides will be evaluated.
Pain associated with orthodontic tooth movement will be assessed using a visual analog scale (VAS) after photobiomodulation. Cone-beam computed tomography (CBCT) examinations obtained before and after the canine retraction period will be used to evaluate changes in maxillary canine root length and alveolar bone dimensions.
Because both interventions are administered within the same participant, the split-mouth design allows direct within-participant comparison of diode laser and LED photobiomodulation while reducing the influence of interindividual biological variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode Laser | Experimental | Device: Diode Laser PhotobiomodulationThe 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. |
| LED | Active comparator | Device: LED PhotobiomodulationThe 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. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Diode Laser PhotobiomodulationDiode 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. | Device | Diode Laser |
| LED PhotobiomodulationThe 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. | Device | LED |
Primary outcome
Amount of Maxillary Canine Retraction
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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.
4 secondary outcomes
Pain Intensity Following Orthodontic Canine Retraction
Time frame: 1 day, 3 days, and 7 days after photobiomodulation
Change in Maxillary Canine Root Length
Time frame: Baseline and 16 weeks
Change in Alveolar Bone Dimensions Around the Maxillary Canine
Time frame: Baseline and 16 weeks
Change in Pulp Oxygen Saturation of the Maxillary Canine
Time frame: Baseline, 20 minutes, 24 hours, 7 days, and 4 weeks after initiation of canine retraction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser Photobiomodulation and LED Photobiomodulation in people with Malocclusion Class I, run by Can Tho University of Medicine and Pharmacy 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lam Le (+84 918130809, lenguyenlam@ctump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Maxillary Canine Retraction (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks). 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 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.