Class II MalocclusionNCT07390357
Effect of Photobiomodulation on Orthodontic Tooth Movement
A study testing 635-nm photobiomodulation in people with Class II Malocclusion and Orthodontic Tooth Movement, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
This study evaluated whether photobiomodulation (PBM), a form of low-level light therapy, can accelerate orthodontic tooth movement during canine distalization in adult patients undergoing fixed orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion, Orthodontic Tooth Movement
- What is being tested?
- 635-nm photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jan 2021to 27 Jul 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Class II malocclusion requiring extraction of maxillary first premolars
- Indication for maxillary canine distalization with absolute anchorage
- Fixed orthodontic treatment for the first time
- Good general health
- Non-smokers
- Good periodontal health
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Uncontrolled periodontal disease
- Systemic diseases or conditions affecting bone metabolism
- Diabetes mellitus or other metabolic disorders
- Pregnancy or breastfeeding
- History of radiotherapy or bisphosphonate therapy
- Use of systemic anti-inflammatory drugs or antibiotics within the previous 12 months
- Poor oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 635-nm Photobiomodulation on Orthodontic Tooth Movement: a Randomized Split-mouth Clinical Trial
This study evaluated whether photobiomodulation (PBM), a form of low-level light therapy, can accelerate orthodontic tooth movement during canine distalization in adult patients undergoing fixed orthodontic treatment.
Eighteen adult patients requiring extraction of maxillary first premolars as part of orthodontic treatment for Class II malocclusion were enrolled. The study used a randomized, controlled, split-mouth design, in which one side of the maxilla was randomly assigned to receive PBM therapy, while the contralateral side served as an untreated control. This design allowed each participant to act as their own control.
Read more
All patients underwent standard orthodontic treatment with fixed appliances and absolute anchorage provided by orthodontic mini-implants. Canine distalization was performed using nickel-titanium closed-coil springs delivering comparable orthodontic forces on both sides. Photobiomodulation was applied on the experimental side using a 635-nm diode laser according to a predefined schedule over a 45-day period, while no laser treatment was applied on the control side.
The primary outcome was the amount of canine tooth movement, measured in millimeters at baseline and at follow-up visits using a calibrated orthodontic caliper. Tooth movement on the laser-treated side was compared with movement on the control side over time.
The purpose of this study was to determine whether photobiomodulation could safely and effectively increase the rate of orthodontic tooth movement without additional surgical intervention or pharmacological treatment.
- Conditions
- Class II Malocclusion, Orthodontic Tooth Movement
- Being tested
- 635-nm photobiomodulation, Sham photobiomodulation
- Keywords
- Photobiomodulation, Orthodontics, Tooth Movement Acceleration
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
635-nm photobiomodulationDevice
Photobiomodulation therapy delivered using a 635-nm diode laser in continuous wave mode. Laser irradiation was applied in contact mode to the post-extraction space and distal aspect of the canine root on the experimental side at predefined time points over a 45-day period.
Sham photobiomodulationDevice
A sham photobiomodulation procedure in which the laser handpiece was placed in contact with the tissues following the same schedule and application protocol as the experimental intervention, but without laser emission.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation-treated side | Experimental | One side of the maxilla randomly assigned to receive photobiomodulation therapy during orthodontic canine distalization. This side received standard fixed orthodontic treatment with absolute anchorage provided by orthodontic mini-implants, combined with 635-nm photobiomodulation therapy applied according to the study protocol. Receives: Device: 635-nm photobiomodulation |
| Sham photobiomodulation-treated side | Placebo comparator | The contralateral side of the maxilla that served as the control. This side underwent the same orthodontic treatment protocol and mechanics as the experimental side. A sham photobiomodulation procedure was performed by placing the laser handpiece in contact with the tissues without light emission, simulating the intervention without delivering therapeutic laser energy. Receives: Device: Sham photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of maxillary canine tooth movement
The amount of orthodontic canine tooth movement was assessed by measuring the linear distance between the central points of the bracket slots bonded to the maxillary canine and first premolar. Measurements were performed using a calibrated orthodontic caliper at baseline (Day 0) and at follow-up visits up to Day 45. Tooth movement was calculated as the change in distance over time.
Measured: Baseline (Day 0) to Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start5 Jan 2021
- Primary completion10 Oct 2021
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Matys, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390357
- Sponsor's protocol ID
- WroclawMU8
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 635-nm Photobiomodulation on Orthodontic Tooth Movement: a Randomized Split-mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07390357
- Acronym / sponsor ID
- WroclawMU8
- Conditions
- Class II Malocclusion, Orthodontic Tooth Movement
- Keywords
- Photobiomodulation, Orthodontics, Tooth Movement Acceleration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 5 Feb 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 evaluated whether photobiomodulation (PBM), a form of low-level light therapy, can accelerate orthodontic tooth movement during canine distalization in adult patients undergoing fixed orthodontic treatment.
Eighteen adult patients requiring extraction of maxillary first premolars as part of orthodontic treatment for Class II malocclusion were enrolled. The study used a randomized, controlled, split-mouth design, in which one side of the maxilla was randomly assigned to receive PBM therapy, while the contralateral side served as an untreated control. This design allowed each participant to act as their own control.
All patients underwent standard orthodontic treatment with fixed appliances and absolute anchorage provided by orthodontic mini-implants. Canine distalization was performed using nickel-titanium closed-coil springs delivering comparable orthodontic forces on both sides. Photobiomodulation was applied on the experimental side using a 635-nm diode laser according to a predefined schedule over a 45-day period, while no laser treatment was applied on the control side.
The primary outcome was the amount of canine tooth movement, measured in millimeters at baseline and at follow-up visits using a calibrated orthodontic caliper. Tooth movement on the laser-treated side was compared with movement on the control side over time.
The purpose of this study was to determine whether photobiomodulation could safely and effectively increase the rate of orthodontic tooth movement without additional surgical intervention or pharmacological treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation-treated side | Experimental | Device: 635-nm photobiomodulationOne side of the maxilla randomly assigned to receive photobiomodulation therapy during orthodontic canine distalization. This side received standard fixed orthodontic treatment with absolute anchorage provided by orthodontic mini-implants, combined with 635-nm photobiomodulation therapy applied according to the study protocol. |
| Sham photobiomodulation-treated side | Placebo comparator | Device: Sham photobiomodulationThe contralateral side of the maxilla that served as the control. This side underwent the same orthodontic treatment protocol and mechanics as the experimental side. A sham photobiomodulation procedure was performed by placing the laser handpiece in contact with the tissues without light emission, simulating the intervention without delivering therapeutic laser energy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years or older
- Class II malocclusion requiring extraction of maxillary first premolars
- Indication for maxillary canine distalization with absolute anchorage
- Fixed orthodontic treatment for the first time
- Good general health
Key exclusion criteria (7 listed)
- Uncontrolled periodontal disease
- Systemic diseases or conditions affecting bone metabolism
- Diabetes mellitus or other metabolic disorders
- Pregnancy or breastfeeding
- History of radiotherapy or bisphosphonate therapy
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 |
|---|---|---|
| 635-nm photobiomodulationPhotobiomodulation therapy delivered using a 635-nm diode laser in continuous wave mode. Laser irradiation was applied in contact mode to the post-extraction space and distal aspect of the canine root on the experimental side at predefined time points over a 45-day period. | Device | Photobiomodulation-treated side |
| Sham photobiomodulationA sham photobiomodulation procedure in which the laser handpiece was placed in contact with the tissues following the same schedule and application protocol as the experimental intervention, but without laser emission. | Device | Sham photobiomodulation-treated side |
Primary outcome
Amount of maxillary canine tooth movement
Time frame: Baseline (Day 0) to Day 45
The amount of orthodontic canine tooth movement was assessed by measuring the linear distance between the central points of the bracket slots bonded to the maxillary canine and first premolar. Measurements were performed using a calibrated orthodontic caliper at baseline (Day 0) and at follow-up visits up to Day 45. Tooth movement was calculated as the change in distance over time.
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 10 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Class II Malocclusion
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 635-nm photobiomodulation in people with Class II Malocclusion and Orthodontic Tooth Movement, run by Wroclaw Medical University at 1 site in Poland.
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 8 inclusion and 7 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 10 Feb 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 Poland. 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?
Amount of maxillary canine tooth movement (time frame: Baseline (Day 0) to Day 45). 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 10 Feb 2026.