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

August 23, 2018 updated by: Biolux Research Holdings, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Suwanee, Georgia, United States, 30024
        • Shaughnessy Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biolux Research Holdings, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (ESTIMATE)

October 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS1.5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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