Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment

NCT ID: NCT06289595

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2024-02-20

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.

Conditions

Orthodontic; Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

PBM

PBM = Use of PBM Ortho device

PBM Ortho device

Intervention Type: DEVICE

Device emits light for photobiomodulation (light therapy).

Control

Did not receive any photobiomodulation treatment.

No interventions assigned to this group

Interventions

PBM Ortho device

Device emits light for photobiomodulation (light therapy).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PBM Healing International Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , Japan

Countries

Japan

Other Identifiers

Pro00134382

Identifier Type: -

Identifier Source: org_study_id