OrthodonticNCT06289595
Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment
An observational study of Orthodontic and Pain, run by PBM Healing International Limited at 7 sites in Japan.
Trial summary
Orthodontic treatment can cause pain. Research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment. In this study, data was collected from the medical charts of patients who had orthodontic treatment and recorded their pain levels for 1 week at the beginning of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic, Pain
- What is being tested?
- PBM Ortho device
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 7 sitesJapan
- Study dates
- 3 Oct 2023to 20 Feb 2024
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that are 18-65 years old, both male and female, that are due to begin orthodontic treatment with either clear aligners or fixed appliances.
Who may be able to join
- Systemically healthy male and female patients (age 18 - 65), i.e., did not suffer from systemic illness nor require medication during the study period.
- Permanent dentition, with Little's Irregularity Index (LII) of 2 mm or greater for the upper and lower arch.
- Orthodontic treatment using clear aligners or fixed appliances via non-extraction therapy.
- Non-smoker with no use of chewing tobacco.
- Good oral hygiene.
- Caries free.
- No sign of periodontal disease.
Who cannot join
- Systemic diseases
- Medication use for the past 6 months; especially use of anti-inflammatory (e.g., NSAIDs)
- Smoking.
- Active dental caries.
- Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets.
- Sleep apnea and other airway pathologies
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- Photosensitivity or use of drugs that may cause photosensitivity
- Use of osteoporosis drugs
- Epilepsy
- Patients who had an implanted cardiac device unless the device is known to not be affected by magnetic fields
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Bio Dental Clinic Ashiya
Ashiya
Sawa Dental Clinic
Kasugai
Soejima Dental Clinic
Kitakyushu
Higashimachigran Dental Clinic
Kumamoto
Tsujimura Dental Clinic
Tanabe
IXI Family Dental Clinic
Tokyo
Miki Dental Clinic
Tokyo
About this study
Official title: Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment With Clear Aligners or Fixed Appliances - a Retrospective, Multicentered Study
Orthodontic treatment can cause pain. Research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment. In this study, data was collected from the medical charts of patients who had orthodontic treatment and recorded their pain levels for 1 week at the beginning of orthodontic treatment while they used a light therapy device or did not use at device. This collected information was used to see if the light therapy device could lessen orthodontic pain.
Read the detailed description
Orthodontic treatment can cause pain. This type of pain is the most common reason why patients stop orthodontic treatment or don't follow the instructions from the orthodontist. A company called PBM Healing has made a dental device called PBM Ortho that is used inside the mouth like a mouthguard. This device uses light therapy called photobiomodulation (PBM) to help with healing, move teeth faster, and lessen inflammation and pain. Other research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment.
In this research study, information from patients' medical charts was collected from 7 dental clinics located in Japan. Some patients at these clinics were asked to use the PBM Ortho device every day for 1 week and to record how much pain they were having. Other patients that did not use this device were simply asked to record their pain level every day for 1 week. This collected information was used to see if the light therapy device could lessen this pain from orthodontic treatment.
- Conditions
- Orthodontic, Pain
- Being tested
- PBM Ortho device
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBM Ortho deviceDevice
Device emits light for photobiomodulation (light therapy).
| Study group | Role | What they receive |
|---|---|---|
| PBM | PBM = Use of PBM Ortho device Receives: Device: PBM Ortho device | |
| Control | Did not receive any photobiomodulation treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Pain
Level of self-reported pain selected on a visual analog scale (VAS) form that rates pain level from 0 (no pain) to 10 (worst pain imaginable).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start3 Oct 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- PBM Healing International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289595
- Sponsor's protocol ID
- Pro00134382
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 4 Mar 2024
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment With Clear Aligners or Fixed Appliances - a Retrospective, Multicentered Study
- ClinicalTrials.gov ID
- NCT06289595
- Acronym / sponsor ID
- Pro00134382
- Conditions
- Orthodontic, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PBM Healing International LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 4 Mar 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.
Orthodontic treatment can cause pain. Research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment. In this study, data was collected from the medical charts of patients who had orthodontic treatment and recorded their pain levels for 1 week at the beginning of orthodontic treatment while they used a light therapy device or did not use at device. This collected information was used to see if the light therapy device could lessen orthodontic pain.
Detailed description
Orthodontic treatment can cause pain. This type of pain is the most common reason why patients stop orthodontic treatment or don't follow the instructions from the orthodontist. A company called PBM Healing has made a dental device called PBM Ortho that is used inside the mouth like a mouthguard. This device uses light therapy called photobiomodulation (PBM) to help with healing, move teeth faster, and lessen inflammation and pain. Other research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment.
In this research study, information from patients' medical charts was collected from 7 dental clinics located in Japan. Some patients at these clinics were asked to use the PBM Ortho device every day for 1 week and to record how much pain they were having. Other patients that did not use this device were simply asked to record their pain level every day for 1 week. This collected information was used to see if the light therapy device could lessen this pain from orthodontic treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM | – | Device: PBM Ortho devicePBM = Use of PBM Ortho device |
| Control | – | –Did not receive any photobiomodulation treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are 18-65 years old, both male and female, that are due to begin orthodontic treatment with either clear aligners or fixed appliances.
Key inclusion criteria (7 listed)
- Systemically healthy male and female patients (age 18 - 65), i.e., did not suffer from systemic illness nor require medication during the study period.
- Permanent dentition, with Little's Irregularity Index (LII) of 2 mm or greater for the upper and lower arch.
- Orthodontic treatment using clear aligners or fixed appliances via non-extraction therapy.
- Non-smoker with no use of chewing tobacco.
- Good oral hygiene.
Key exclusion criteria (10 listed)
- Systemic diseases
- Medication use for the past 6 months; especially use of anti-inflammatory (e.g., NSAIDs)
- Smoking.
- Active dental caries.
- Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets.
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 |
|---|---|---|
| PBM Ortho deviceDevice emits light for photobiomodulation (light therapy). | Device | PBM |
Primary outcome
Level of Pain
Time frame: 7 days
Level of self-reported pain selected on a visual analog scale (VAS) form that rates pain level from 0 (no pain) to 10 (worst pain imaginable).
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 4 Mar 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthodontic and Pain, run by PBM Healing International Limited at 7 sites in Japan.
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 7 inclusion and 10 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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?
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?
Level of Pain (time frame: 7 days). 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 4 Mar 2024.