Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment

Pain Clinical Trial

Official title:

Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment With Clear Aligners or Fixed Appliances - a Retrospective, Multicentered Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06289595
• Other study ID #: Pro00134382
• Status: Completed
• Start date: October 3, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: February 2024
• Source: PBM Healing International Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic
• Pain

Intervention

Device:
• PBM Ortho device
Device emits light for photobiomodulation (light therapy).

Locations

Country	Name	City	State
Japan	Bio Dental Clinic Ashiya	Ashiya
Japan	Sawa Dental Clinic	Kasugai
Japan	Soejima Dental Clinic	Kitakyushu
Japan	Higashimachigran Dental Clinic	Kumamoto
Japan	Tsujimura Dental Clinic	Tanabe
Japan	IXI Family Dental Clinic	Tokyo
Japan	Miki Dental Clinic	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
PBM Healing International Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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