The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
Not Applicable
Completed
- Conditions
- Malocclusion
- Registration Number
- NCT02267824
- Lead Sponsor
- Biolux Research Holdings, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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. Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the effects of extraoral photobiomodulation on orthodontic alignment?
How does OrthoPulse® compare to traditional orthodontic treatments in terms of alignment speed and patient outcomes?
Are there specific biomarkers that predict patient response to extraoral LED photobiomodulation therapy for malocclusion?
What adverse events are associated with extraoral photobiomodulation in orthodontic treatment and how are they managed?
What combination therapies or competitor devices are being explored alongside photobiomodulation for orthodontic alignment?
Trial Locations
- Locations (4)
Department of Orthodontics, School of Dentistry, University of Alabama
🇺🇸Birmingham, Alabama, United States
Shaughnessy Orthodontics
🇺🇸Suwanee, Georgia, United States
Clinique Dentaire Alvaro de la Fuente
🇨🇦L'Île-Perrot, Quebec, Canada
Department of Orthodontics, Faculty of Dentistry, Mahidol University
🇹🇭Bangkok, Thailand
Department of Orthodontics, School of Dentistry, University of Alabama🇺🇸Birmingham, Alabama, United States