Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment

Completed

• Conditions: Pain; Orthodontic
• Interventions: Device: PBM Ortho device

• Registration Number: NCT06289595
• Lead Sponsor: PBM Healing International Limited

Brief 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 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 Timeline

• Study Start: 2023-10-03
• Status Verified: 2024-02
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-20
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PBM	PBM Ortho device	PBM = Use of PBM Ortho device

Primary Outcome Measures

Name	Time	Method
Level of Pain	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).

Trial Locations

Locations (7)

IXI Family Dental Clinic; 🇯🇵 Tokyo, Japan

Sawa Dental Clinic; 🇯🇵 Kasugai, Japan

Bio Dental Clinic Ashiya; 🇯🇵 Ashiya, Japan

Miki Dental Clinic; 🇯🇵 Tokyo, Japan

Soejima Dental Clinic; 🇯🇵 Kitakyushu, Japan

Higashimachigran Dental Clinic; 🇯🇵 Kumamoto, Japan

Tsujimura Dental Clinic; 🇯🇵 Tanabe, Japan