Impact of photobiomodulation on pain associated with orthodontic treatment

Not Applicable

Completed

• Conditions: Reduction of pain associated with orthodontic treatment in patients undergoing orthodontic treatment; Oral Health

• Registration Number: ISRCTN16566195
• Lead Sponsor: PBM Healing International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-02-20
• Study Start: 2024-03-01
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.Systemically healthy male and female patients (age 18 - 65), i.e., did not suffer from systemic illness nor require medication during the study period.
2.Permanent dentition, with Little's Irregularity Index (LII) of 2 mm or greater for the upper and lower arch.
3.Orthodontic treatment using clear aligners or fixed appliances via non-extraction therapy.
4.Non-smoker with no use of chewing tobacco.
5.Good oral hygiene.
6.Caries free.
7.No sign of periodontal disease.

Exclusion Criteria

1.Systemic diseases
2.Medication use for the past 6 months; especially use of anti-inflammatory (e.g., NSAIDs)
3.Smoking.
4.Active dental caries.
5.Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets.
6.Sleep apnea and other airway pathologies
7.Photosensitivity or use of drugs that may cause photosensitivity
8.Use of osteoporosis drugs
9.Epilepsy
10.Patients who had an implanted cardiac device unless the device is known to not be affected by magnetic fields

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported pain level for 7 days using a visual analog scale form (0 = no pain, 10 = worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Any report of adverse events measured using patient records throughout the study