OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study
Not Applicable
Completed
- Conditions
- Malocclusion
- Registration Number
- NCT02267837
- Lead Sponsor
- Biolux Research Holdings, Inc.
- Brief Summary
The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Presence of permanent dentition
- Eligible and scheduled for full mouth fixed orthodontic treatment
- Class I or Class II malocclusion (no more than ½ cusp in Class II)
- Non-extraction in all quadrants
- Non-smoker
- Good oral hygiene as determined by the investigator
- No adjunct treatment such as extra- or intra-oral appliances
Exclusion Criteria
- Pregnant females
- Patient is currently enrolled in another clinical study
- Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
- Periodontally involved teeth
- Use of bisphosphonates
- Unerupted or partially erupted maxillary teeth
- Teeth blocked out of alignment and unable to engage initial arch wire
- Spaces present in the maxillary arch
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 OrthoPulse™ and Non-OrthoPulse™ 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 OrthoPulse™ LED photobiomodulation in accelerating orthodontic tooth movement?
How does OrthoPulse™ compare to corticosteroid injections in managing orthodontic inflammation and tooth alignment speed?
Are there specific biomarkers that predict enhanced orthodontic response to intra-oral photobiomodulation therapy?
What adverse events are associated with LED photobiomodulation devices in orthodontic treatment protocols?
What combination therapies with OrthoPulse™ could enhance orthodontic tooth alignment in malocclusion patients?
Trial Locations
- Locations (1)
Shaughnessy Orthodontics
🇺🇸Suwanee, Georgia, United States
Shaughnessy Orthodontics🇺🇸Suwanee, Georgia, United States