N/A
N=29
Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time
Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT02267850 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. — 19.0; 21.2 months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fixed Orthodontic Appliance Treatment (Other); OrthoPulse™ (Device); Non-Functional OrthoPulse™ (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Biolux Research Holdings, Inc.
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. |
19.0; 21.2 | — |
Summary
The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a double-blinded RCT with half the patients receiving treatment from a sham non-functional device, serving as controls, and the other half receiving light therapy treatment from a functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared to that of the OrthoPulse™ patients.
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, non-use of chewing tobacco
- Good oral hygiene
- No adjunct treatment such as extra or intraoral appliances
- Age 12-40
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 erupted teeth
- Teeth blocked out of alignment and unable to engage initial arch wire
Data sourced from ClinicalTrials.gov (NCT02267850). 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.