Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment

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.

Study Overview

• Status: Completed
• Conditions: Pain; Orthodontic
• Intervention / Treatment: Device: PBM Ortho device

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Japan
  • Ashiya, Japan
    • Bio Dental Clinic Ashiya
  • Kasugai, Japan
    • Sawa Dental Clinic
  • Kitakyushu, Japan
    • Soejima Dental Clinic
  • Kumamoto, Japan
    • Higashimachigran Dental Clinic
  • Tanabe, Japan
    • Tsujimura Dental Clinic
  • Tokyo, Japan
    • IXI Family Dental Clinic
  • Tokyo, Japan
    • Miki Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PBM; PBM = Use of PBM Ortho device	Device: PBM Ortho device; Device emits light for photobiomodulation (light therapy).
Control; Did not receive any photobiomodulation treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 days

Collaborators and Investigators

• Sponsor: PBM Healing International Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00134382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No