Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment

NCT06289595 | Completed

• 1 other identifier: Pro00134382
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 7

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.

Conditions

Orthodontic; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PBM

PBM = Use of PBM Ortho device

Device: PBM Ortho device

Control

Did not receive any photobiomodulation treatment.

Interventions

PBM Ortho device DEVICE

Device emits light for photobiomodulation (light therapy).

PBM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PBM Healing International Limited: lead

Study Sites (7)

Bio Dental Clinic Ashiya

Ashiya, Japan

Location

Sawa Dental Clinic

Kasugai, Japan

Location

Soejima Dental Clinic

Kitakyushu, Japan

Location

Higashimachigran Dental Clinic

Kumamoto, Japan

Location

Tsujimura Dental Clinic

Tanabe, Japan

Location

IXI Family Dental Clinic

Tokyo, Japan

Location

Miki Dental Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 4, 2024
• Study Start: October 3, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7)