N/A
N=101
The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT02267824 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients. — 1.12; 0.49 millimeters per week (mm/wk)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Extraoral OrthoPulse® PBM (Device); Fixed Orthodontic Appliance Treatment (Other)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Biolux Research Holdings, Inc.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients. |
1.12; 0.49 | — |
Summary
The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment.
Eligibility Criteria
Inclusion Criteria
- Permanent dentition
- Class I malocclusion with irregularity score of greater than 2 mm in either arch
- Good oral hygiene
Exclusion Criteria
- Any medical or dental condition that could potentially affect study results
- Patients currently using any investigational drug or any other investigational device
- Patients planning to relocate or move during the treatment period
- Use of bisphosphonates
- Pregnant females
Data sourced from ClinicalTrials.gov (NCT02267824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.