Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time
This trial has been completed.
|Treatments||fixed orthodontic appliance treatment, orthopulse™, non-functional orthopulse™|
|Sponsor||Biolux Research Ltd.|
|Start date||May 2013|
|End date||May 2016|
|Trial size||29 participants|
|Trial identifier||NCT02267850, TS2|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Overall orthodontic treatment time for OrthoPulse™ and non-OrthoPulse™ treated patients.
time frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.
Male or female participants from 12 years up to 40 years old.
- 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
- 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
|Official title||Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time: A Randomized Control Trial|
|Principal investigator||Timothy Shaughnessy, DDS|
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