Clinical trial NCT02267837: OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study
Official title: OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Alignment phase
Photobiomodulation
Orthodontic treatment
Malocclusion
OrthoPulse™
Lead sponsor: Biolux Research Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_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 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

Primary outcomes:
measure: 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.
timeFrame: 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 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
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