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OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study

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ClinicalTrials.gov Identifier: NCT02267837
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : September 11, 2015
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Biolux Research Holdings, Inc.

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.

Condition or disease Intervention/treatment Phase
Malocclusion Device: OrthoPulse™ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study.
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: OrthoPulse™
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Device: OrthoPulse™
Patients carry out daily OrthoPulse™ treatments at home.

No Intervention: Control
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.



Primary Outcome Measures :
  1. 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. [ Time Frame: 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267837


Locations
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United States, Georgia
Shaughnessy Orthodontics
Suwanee, Georgia, United States, 30024
Sponsors and Collaborators
Biolux Research Holdings, Inc.
Investigators
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Principal Investigator: Timothy Shaughnessy, DDS Shaughnessy Orthodontics
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biolux Research Holdings, Inc.
ClinicalTrials.gov Identifier: NCT02267837    
Other Study ID Numbers: TS1.5
First Posted: October 20, 2014    Key Record Dates
Results First Posted: September 11, 2015
Last Update Posted: August 27, 2018
Last Verified: August 2018
Keywords provided by Biolux Research Holdings, Inc.:
Alignment phase
Photobiomodulation
Orthodontic treatment
Malocclusion
OrthoPulse™
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases