OrthodonticsNCT06199674
Effects of PBM on Fixed-appliance Orthodontic Patients
A study testing photobiomodulation therapy and orthodontic fixed-appliance in people with Orthodontics and Root Resorption, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The aim of this study is to investigate the effects of photobiomodulation therapy (PBM) on the dental and periodontal health of patients undergoing fixed-appliance orthodontic treatment, including orthodontically induced root resorption, orthodontic pain, space closing rate, and dental microbiome profile in dental… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Orthodontics, Root Resorption
- What is being tested?
- photobiomodulation therapy and orthodontic fixed-appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jan 2024to 1 Dec 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 18 and 35 years old with permanent dentition
- Patients who undertake orthodontic treatment using fixed appliances
- Patients who require extraction of premolars in either their upper or lower dental arch
- Patients who have fair oral hygiene habits
- Patients who are systemically healthy
Who cannot join
- Patients with generalized dental caries and severe chronic periodontitis in stages III and IV
- Patients with congenital or severe craniofacial anomalies which necessitate orthognathic surgery
- Patients with physical or mental impairment, and those who smoke or undertake systemic medications
- Patients with current root resorption at any of the teeth
- Patients with endodontic treatment and/or large restorations on premolars to be extracted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Photobiomodulation Therapy (PBM) on Dental and Periodontal Health of Patients Undergoing Fixed-appliance Orthodontic Treatment
The aim of this study is to investigate the effects of photobiomodulation therapy (PBM) on the dental and periodontal health of patients undergoing fixed-appliance orthodontic treatment, including orthodontically induced root resorption, orthodontic pain, space closing rate, and dental microbiome profile in dental plaques.
Read the detailed description
Photobiomodulation therapy (PBM) is a non-invasive, adjunctive medical treatment that has promising effects on various dental and oral conditions, including controlling inflammation, promoting wound healing, and relieving pain. While animal studies have explored PBM therapy in orthodontics for accelerating tooth movement, preventing root resorption, alleviating pain, and controlling periodontal inflammation, clinical studies with high-quality evidence remain limited. Therefore, a randomized controlled trial (RCT) will be conducted to investigate the effects of a portable PBM device on the dental and periodontal health of patients undergoing fixed-appliance orthodontic treatment. This two-arm RCT will be conducted with a triple-blinded and parallel study design in a 1:1 ratio. Fifty orthodontic patients will be recruited at the Prince Philip Dental Hospital following the eligibility criteria from Jan. 2024 to Jan. 2026 (24 months) and evenly distributed to the two arms. Randomization and allocation will be conducted by a statistician who will not participate in the intervention and outcome assessment process using computer software. Participants in the PBM group will be required to wear a PBM device, while those in the control group will receive a sham device with an identical appearance to the PBM device but without light irradiation. All participants must wear their assigned device daily for 8 minutes (4 minutes for the upper and lower dental arches each) after brushing their teeth during the process of fixed-appliance orthodontic treatment. The allocation sequences will be concealed in a batch of opaque envelopes. Patients and the outcome assessor will be blinded to the allocation sequence. This protocol is proposed in compliance with the Declaration of Helsinki and the ICH-Good Clinical Practice (GCP) Guideline. The study will be conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guideline. Written consent will be obtained from all subjects.
- Conditions
- Orthodontics, Root Resorption
- Being tested
- photobiomodulation therapy, orthodontic fixed-appliance
- Keywords
- photobiomodulation, fixed-appliance orthodontic treatment, root resorption, orthodontic pain, tooth movement
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulation therapyDevice
Patients in the PBM group will be delivered a portable PBM device (PBM Healing Ortho) at the beginning of orthodontic treatment and will be instructed to use it daily at home for 8 minutes (4 min per arch) after tooth brushing.
orthodontic fixed-applianceOther
All eligible patients will receive orthodontic treatment with a pre-adjusted fixed appliance (0.022'' × 0.028'' slot system, MBT, 3M Unitek) provided by the same practitioner. At the start of treatment, a cantilever auxiliary arch bent with a 0.017'' × 0.025'' Stainless Steel wire (3M Unitek) will be used to apply a 100 g intrusion force to the premolars that will be extracted in 3 months. All other teeth will undergo regular orthodontic treatment with a standard archwire protocol (0.014'' NiTi, 0.016'' NiTi, 0.018'' NiTi, 0.017'' × 0.025'' NiTi, 0.019'' × 0.025'' NiTi, and 0.019'' × 0.025'' SS, 0.019'' × 0.025'' TMA) for alignment, leveling, space closure, detailing, and finishing. For en masse retraction, a 150 g force will be applied by coil springs, allowing bracket slots to slide along the 0.019'' × 0.025'' SS.
| Study group | Role | What they receive |
|---|---|---|
| PBM group | Experimental | wear PBM device daily during the fixed-appliance orthodontic treatment Receives: Device: photobiomodulation therapy; Other: orthodontic fixed-appliance |
| Control group | Sham comparator | wear sham device daily during the fixed-appliance orthodontic treatment Receives: Other: orthodontic fixed-appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic-induced inflammatory root resorption (OIIRR)
Record OIIRR by calculating the volume of craters on the root surfaces of the extracted tooth using a standard micro-CT machine after 3 months following intrusions by cantilever auxiliary arch.
Measured: baseline, 3 months after intrusive force loading
Secondary outcomes (3)
Orthodontic pain
Record orthodontic pain monthly since the beginning of regular orthodontic treatment by patients' self-registration on a 100-millimetre Visual Analogue Scale (VAS). 0 means "no pain", 100 means "worst pain", the higher the score, the more severe the pain. In addition, 5-millilitre unstimulated saliva samples will be collected from each participant with the same time scheme for evaluation of pain-related biomarkers.
Measured: baseline, immediately after fixed appliance placement and immediately after adjustment every month during the first year of regular orthodontic treatment
Space closure by en masse retraction
Record the duration of the space closure by calculating the rate of tooth movement (mm/mo) with physically measurement. In addition, gingival crevicular fluid samples will be collected from the two space-neighbouring teeth to analyse bone-related biomarkers.
Measured: every month from the start of space closure to the end of closure, taking into account the very slow closure of space, assessed up to 12 months
Microbiome profile in dental plaques
Samples of supragingival and subgingival plaques will proceed to 16S rRNA sequencing for analysis of microbiome profiles, and q-PCR for evaluating bacterial loads of some critical pathogens for dental caries and periodontitis.
Measured: baseline, every 3 months from the start of regular orthodontic treatment to the end of treatment process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start20 Jan 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyi Shan, The University of Hong Kong
- Investigators
- Zhiyi Shan, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199674
- Sponsor's protocol ID
- PBMRR-HKU-143
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation Therapy (PBM) on Dental and Periodontal Health of Patients Undergoing Fixed-appliance Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT06199674
- Acronym / sponsor ID
- PBMRR-HKU-143
- Conditions
- Orthodontics, Root Resorption
- Keywords
- photobiomodulation, fixed-appliance orthodontic treatment, root resorption, orthodontic pain, tooth movement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Jan 2024 (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.
The aim of this study is to investigate the effects of photobiomodulation therapy (PBM) on the dental and periodontal health of patients undergoing fixed-appliance orthodontic treatment, including orthodontically induced root resorption, orthodontic pain, space closing rate, and dental microbiome profile in dental plaques.
Detailed description
Photobiomodulation therapy (PBM) is a non-invasive, adjunctive medical treatment that has promising effects on various dental and oral conditions, including controlling inflammation, promoting wound healing, and relieving pain. While animal studies have explored PBM therapy in orthodontics for accelerating tooth movement, preventing root resorption, alleviating pain, and controlling periodontal inflammation, clinical studies with high-quality evidence remain limited. Therefore, a randomized controlled trial (RCT) will be conducted to investigate the effects of a portable PBM device on the dental and periodontal health of patients undergoing fixed-appliance orthodontic treatment. This two-arm RCT will be conducted with a triple-blinded and parallel study design in a 1:1 ratio. Fifty orthodontic patients will be recruited at the Prince Philip Dental Hospital following the eligibility criteria from Jan. 2024 to Jan. 2026 (24 months) and evenly distributed to the two arms. Randomization and allocation will be conducted by a statistician who will not participate in the intervention and outcome assessment process using computer software. Participants in the PBM group will be required to wear a PBM device, while those in the control group will receive a sham device with an identical appearance to the PBM device but without light irradiation. All participants must wear their assigned device daily for 8 minutes (4 minutes for the upper and lower dental arches each) after brushing their teeth during the process of fixed-appliance orthodontic treatment. The allocation sequences will be concealed in a batch of opaque envelopes. Patients and the outcome assessor will be blinded to the allocation sequence. This protocol is proposed in compliance with the Declaration of Helsinki and the ICH-Good Clinical Practice (GCP) Guideline. The study will be conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guideline. Written consent will be obtained from all subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM group | Experimental | Device: photobiomodulation therapy, Other: orthodontic fixed-appliancewear PBM device daily during the fixed-appliance orthodontic treatment |
| Control group | Sham comparator | Other: orthodontic fixed-appliancewear sham device daily during the fixed-appliance orthodontic treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 35 years old with permanent dentition
- Patients who undertake orthodontic treatment using fixed appliances
- Patients who require extraction of premolars in either their upper or lower dental arch
- Patients who have fair oral hygiene habits
- Patients who are systemically healthy
Key exclusion criteria (5 listed)
- Patients with generalized dental caries and severe chronic periodontitis in stages III and IV
- Patients with congenital or severe craniofacial anomalies which necessitate orthognathic surgery
- Patients with physical or mental impairment, and those who smoke or undertake systemic medications
- Patients with current root resorption at any of the teeth
- Patients with endodontic treatment and/or large restorations on premolars to be extracted
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 |
|---|---|---|
| photobiomodulation therapyPatients in the PBM group will be delivered a portable PBM device (PBM Healing Ortho) at the beginning of orthodontic treatment and will be instructed to use it daily at home for 8 minutes (4 min per arch) after tooth brushing. | Device | PBM group |
| orthodontic fixed-applianceAll eligible patients will receive orthodontic treatment with a pre-adjusted fixed appliance (0.022'' × 0.028'' slot system, MBT, 3M Unitek) provided by the same practitioner. At the start of treatment, a cantilever auxiliary arch bent with a 0.017'' × 0.025'' Stainless Steel wire (3M Unitek) will be used to apply a 100 g intrusion force to the premolars that will be extracted in 3 months. All other teeth will undergo regular orthodontic treatment with a standard archwire protocol (0.014'' NiTi, 0.016'' NiTi, 0.018'' NiTi, 0.017'' × 0.025'' NiTi, 0.019'' × 0.025'' NiTi, and 0.019'' × 0.025'' SS, 0.019'' × 0.025'' TMA) for alignment, leveling, space closure, detailing, and finishing. For en masse retraction, a 150 g force will be applied by coil springs, allowing bracket slots to slide along the 0.019'' × 0.025'' SS. | Other | Control group, PBM group |
Primary outcome
Orthodontic-induced inflammatory root resorption (OIIRR)
Time frame: baseline, 3 months after intrusive force loading
Record OIIRR by calculating the volume of craters on the root surfaces of the extracted tooth using a standard micro-CT machine after 3 months following intrusions by cantilever auxiliary arch.
3 secondary outcomes
Orthodontic pain
Time frame: baseline, immediately after fixed appliance placement and immediately after adjustment every month during the first year of regular orthodontic treatment
Space closure by en masse retraction
Time frame: every month from the start of space closure to the end of closure, taking into account the very slow closure of space, assessed up to 12 months
Microbiome profile in dental plaques
Time frame: baseline, every 3 months from the start of regular orthodontic treatment to the end of treatment process
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 24 Jun 2026.
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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.
Zhiyi Shan principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photobiomodulation therapy and orthodontic fixed-appliance in people with Orthodontics and Root Resorption, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 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 Hong Kong. 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?
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?
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?
Orthodontic-induced inflammatory root resorption (OIIRR) (time frame: baseline, 3 months after intrusive force loading). 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 24 Jun 2026.