N/A
N=20
OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study
Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT02267837 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: 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. — 1.27; 0.43 millimeters per week (mm/wk)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OrthoPulse™ (Device)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Biolux Research Holdings, Inc.
- Primary completion
- Dec 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 OrthoPulse™ and Non-OrthoPulse™ Treated Patients. |
1.27; 0.43 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02267837). 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.