An interventional study of Diode Laser Photobiomodulation and LED Photobiomodulation in Malocclusion Class I, sponsored by Can Tho University of Medicine and Pharmacy. Recruiting at 1 site in Vietnam. Open to participants aged 15 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Can Tho University of Medicine and Pharmacy · Not applicable, Interventional, and 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.
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.
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.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 34 is close to the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Can Tho University of Medicine and Pharmacy is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 20 minutes, 24 hours, 7 days, and 4 weeks after initiation of canine retraction.
Plan to share: No
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Started Jan 2026 (actual). Primary completion is estimated for Jul 2027, 18 months after the start.
Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 18 months is close to that.
Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.
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Can Tho University of Medicine and Pharmacy