Impact of photobiomodulation on pain associated with orthodontic treatment
| ISRCTN | ISRCTN16566195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16566195 |
| Secondary identifying numbers | Pro00134382 |
- Submission date
- 29/02/2024
- Registration date
- 01/03/2024
- Last edited
- 26/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study investigates how using photobiomodulation (PBM) affects the pain that comes with orthodontic treatment. Photobiomodulation is a therapy that uses light to stimulate biological processes in the body. We're exploring whether this therapy can help reduce the discomfort often experienced during orthodontic procedures.
This study was a retrospective study that collected information and data from the dental charts of patients who provided informed consent/authorization to the dental clinic to use their data for research purposes.
Who can participate?
Patients at 7 dental clinics in Japan aged 18 - 65 years.
What does the study involve?
Patients were asked to use an intraoral light therapy device called PBM Ortho and to record their pain level on a scale from 0 to 10 (0 = no pain, 10 = worst pain imaginable) for 7 days at the beginning of orthodontic treatment with either clear aligners or fixed appliances. The device was to be used for 4 minutes per arch, so a total of 8 minutes per day. Other patients were asked to just record their pain levels in the same manner as described, but they did not use any device.
The PBM Ortho devices were made by a company called PBM Healing International Limited. This study aimed to investigate the impact of this light therapy device on orthodontic pain.
What are the possible benefits and risks of participating?
Patients that used the device may have experienced a reduction in pain, but there were no risks with using the device.
Where is the study run from?
PBM Healing International Limited (Hong Kong)
When is the study starting and how long is it expected to run for?
October 2023 to February 2024
Who is funding the study?
PBM Healing International Limited (Hong Kong)
Who is the main contact?
Dr Alan Kwong Hing, dr.al@pbmhealing.com
Contact information
Public, Scientific, Principal Investigator
Unit D, 23/F, Sun Ying Industrial Centre, 9 Tin Wan Close
Aberdeen
-
Hong Kong
| Phone | +852 3611 2573 |
|---|---|
| dr.al@pbmhealing.com |
Study information
| Study design | Multicenter 7-day case-control retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Impact of photobiomodulation on pain associated with orthodontic treatment with clear aligners or fixed appliances - a retrospective, multicentre study |
| Study objectives | Photobiomodulation (PBM) reduces orthodontic pain |
| Ethics approval(s) |
Approved 03/10/2023, University of Alberta Research Ethics Board (2-01 North Power Plant (NPP), 11312 - 89 Avenue NW, Edmonton, T6G 2N2, Canada; +1-780-492-0459; reoffice@ualberta.ca), ref: Pro00134382 |
| Health condition(s) or problem(s) studied | Reduction of pain associated with orthodontic treatment in patients undergoing orthodontic treatment |
| Intervention | Upon starting orthodontic treatment with either clear aligners or fixed appliances, some patients were asked to use the PBM Ortho device and to record their pain level every day for 7 days, and some patients were asked to record their pain levels every day for 7 days without using any devices. The PBM Ortho device is an intraoral device with a mouthpiece that produces photobiomodulation, also know as low level laser/light therapy, for 4 minutes per arch. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | PBM Ortho device |
| Primary outcome measure | Self-reported pain level for 7 days using a visual analog scale form (0 = no pain, 10 = worst pain imaginable) |
| Secondary outcome measures | Any report of adverse events measured using patient records throughout the study |
| Overall study start date | 03/10/2023 |
| Completion date | 20/02/2024 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 32 |
| Total final enrolment | 32 |
| Key inclusion criteria | 1. Systemically healthy male and female patients (age 18 - 65), i.e., did not suffer from systemic illness nor require medication during the study period. 2. Permanent dentition, with Little's Irregularity Index (LII) of 2 mm or greater for the upper and lower arch. 3. Orthodontic treatment using clear aligners or fixed appliances via non-extraction therapy. 4. Non-smoker with no use of chewing tobacco. 5. Good oral hygiene. 6. Caries free. 7. No sign of periodontal disease. |
| Key exclusion criteria | 1. Systemic diseases 2. Medication use for the past 6 months; especially use of anti-inflammatory (e.g., NSAIDs) 3. Smoking. 4. Active dental caries. 5. Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets. 6. Sleep apnea and other airway pathologies 7. Photosensitivity or use of drugs that may cause photosensitivity 8. Use of osteoporosis drugs 9. Epilepsy 10. Patients who had an implanted cardiac device unless the device is known to not be affected by magnetic fields |
| Date of first enrolment | 03/10/2023 |
| Date of final enrolment | 20/02/2024 |
Locations
Countries of recruitment
- Japan
Study participating centres
183-0015
Japan
486-0806
Japan
646-0028
Japan
187-0021
Japan
659-0065
Japan
830-0032
Japan
860-0952
Japan
Sponsor information
Industry
Unit D, 23/F, Sun Ying Industrial Centre, 9 Tin Wan Close
Aberdeen
-
Hong Kong
| Phone | +852 3611 2573 |
|---|---|
| pbmstudies@pbmhealing.com | |
| Website | http://www.pbmhealing.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study results will be published in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study may be available upon reasonable request from Dr. Jacqueline Crossman (jacqueline@pbmhealing.com). |
Editorial Notes
27/07/2024: The intention to publish date was changed from 01/07/2024 to 01/10/2024.
09/05/2024: The sponsor email was changed.
01/03/2024: Trial's existence confirmed by University of Alberta Research Ethics Board.
