PBM Ortho Active device for Crossbite

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sphinx Orthodontic, Edmonton, Canada
Crossbite+1 More
PBM Ortho - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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 reduced the orthodontic associated pain in the clear aligner patients. This effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva.

Eligible Conditions

  • Crossbite
  • Orthodontic Treatment

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Day 7

Day 7
Visual analog scale
Day 7
Saliva analysis

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

PBM Ortho Active device
1 of 2
PBM Ortho Sham
1 of 2
Active Control
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: PBM Ortho Active device · Has Placebo Group · N/A

PBM Ortho Sham
Device
ShamComparator Group · 1 Intervention: PBM Ortho · Intervention Types: Device
PBM Ortho Active device
Device
ActiveComparator Group · 1 Intervention: PBM Ortho · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 7
Closest Location: Sphinx Orthodontic · Edmonton, Canada
Photo of Edmonton  1Photo of Edmonton  2Photo of Edmonton  3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Crossbite
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Treatment using clear aligners via non-extraction therapy.
You are willing and able to comply with the requirements of this trial protocol.
You have good oral hygiene.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References