Clinical trial NCT06289595: Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment
Official title: Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment With Clear Aligners or Fixed Appliances - a Retrospective, Multicentered Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthodontic
Pain
Lead sponsor: PBM Healing International Limited
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Level of Pain
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ashiya
country: Japan
facility: Bio Dental Clinic Ashiya
city: Kasugai
country: Japan
facility: Sawa Dental Clinic
city: Kitakyushu
country: Japan
facility: Soejima Dental Clinic
city: Kumamoto
country: Japan
facility: Higashimachigran Dental Clinic
city: Tanabe
country: Japan
facility: Tsujimura Dental Clinic
city: Tokyo
country: Japan
facility: IXI Family Dental Clinic
city: Tokyo
country: Japan
facility: Miki Dental Clinic
Study officials:
References: