Using light therapy to reduce pain during orthodontic treatment with clear aligners
Impact of Photobiomodulation on Pain During Orthodontic Treatment
This study is testing if a light therapy device can help adults with clear aligners feel less pain during their orthodontic treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | PBM Healing International Limited Industry-sponsored |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Trial ID | NCT05361616 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a photobiomodulation device, PBM Ortho, on pain experienced by adult patients undergoing orthodontic treatment with clear aligners. Participants will use either the active PBM device or a sham device at home for eight minutes daily over a week. Pain levels will be assessed using a visual analog scale before and during treatment, and saliva samples will be collected to analyze inflammatory proteins associated with pain. The goal is to determine if this light therapy can alleviate discomfort and improve patient compliance during orthodontic treatment.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 20 to 65 who require orthodontic treatment with clear aligners and have specific dental conditions.
Not a fit: Patients with systemic diseases, active dental issues, or those using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce orthodontic pain, leading to better patient compliance and treatment outcomes.
How similar studies have performed: While the use of photobiomodulation in orthodontics is a relatively novel approach, preliminary studies have shown promising results in pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systemically healthy male and female patients (age 20 to 65), i.e., do not suffer from systemic illness nor require medication during the saliva collection 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 via non-extraction therapy. * Patient is available for follow-up visits. * Patient is able and willing to comply with the requirements of this trial protocol. * 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; specially use of anti-inflammatory (e.g., NSAIDs), antiviral, antibiotics. * Smoking. * Active dental caries. * Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets. * Sleep apnea and other airway pathologies.
Where this trial is running
Edmonton, Alberta and 1 other locations
- Sphinx Orthodontic — Edmonton, Alberta, Canada (Recruiting)
- Orthodontic Graduate Clinic, Kaye Clinic, University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Tarek El-Bialy, PhD
- Email: telbialy@ualberta.ca
- Phone: 7806953110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.