Clinical trial NCT02267850: Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time
Official title: Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Photobiomodulation
Orthodontic treatment
Malocclusion
OrthoPulse™
Lead sponsor: Biolux Research Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Suwanee
country: United States
facility: Shaughnessy Orthodontics
state: Georgia
Study officials:
affiliation: Shaughnessy Orthodontics
name: Timothy Shaughnessy, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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