Status:
COMPLETED
Impact of Photobiomodulation on Pain During Orthodontic Treatment.
Lead Sponsor:
PBM Healing International Limited
Conditions:
Malocclusion
Orthodontic Treatment
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
The objective of this study is to determine to effect of PBM Ortho, a photobiomodulation device, in adult patients undergoing clear aligners orthodontic treatment. We hypothesize that PBM Ortho will r...
Detailed Description
Pain associated with orthodontic treatment is one of the main causes of treatment discontinuation and patient non-cooperation. Several treatment modalities have been studied to alleviate orthodontic p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05361616
Start Date
April 17 2023
End Date
January 1 2025
Last Update
June 4 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sphinx Orthodontic
Edmonton, Alberta, Canada, T5K 2L2
2
Orthodontic Graduate Clinic, Kaye Clinic, University of Alberta
Edmonton, Alberta, Canada, T6G 1Z1