OrthoPulse 2.0 and 2.1 Feasibility Evaluation (BX13)

October 21, 2019 updated by: Biolux Research Holdings, Inc.

OrthoPulse 2.0 and 2.1 Product Evaluation and Assessing Clinical Effectiveness: A Feasibility Study

OrthoPulse is a device that uses near-infrared light therapy in order to decrease orthodontic treatment time. The aim of this study is to evaluate OrthoPulse products modified with extended arrays, OrthoPulse 2.0 and OrthoPulse 2.1, and to assess their clinical effectiveness.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5K 2L2
        • Sphinx Orthodontics
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Dickerson Orthodontics
      • Peoria, Arizona, United States, 85382
        • Dickerson Orthodontics
      • Phoenix, Arizona, United States, 85028
        • Dickerson Orthodontics
      • Scottsdale, Arizona, United States, 85254
        • Dickerson Orthodontics
    • California
      • San Francisco, California, United States, 94118
        • Bella Smile
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Chenin 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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written Informed Consent must be obtained before any assessment is performed
  • Patient must be 11 years of age or older; minors will only be included in the study with the consent of the Parent/Legal Authorized Representative (LAR)
  • Presence of permanent dentition
  • Eligible and scheduled for full mouth fixed orthodontic treatment or Invisalign
  • Good oral hygiene
  • Likely to be compliant to OrthoPulse 2.0 and 2.1 use, aligner wear and elastic wear
  • Have a compatible iOS or Android device and are willing to download the OrthoPulse app for frequent automatic syncing of use data

Exclusion Criteria:

  • Patient is currently enrolled in another clinical study
  • Periodontally involved teeth, acute oral infection or periodontal disease
  • Use of bisphosphonates (osteoporosis drugs) during the study
  • Use of drugs that may cause photosensitivity
  • History of photosensitivity
  • History of poor oral hygiene, per the discretion of the Principal Investigator (PI)
  • Epilepsy
  • Patient plans to relocate over the treatment period
  • Smoker or use of any tobacco containing products per the discretion of the PI

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I-OP2.0
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
Device: OrthoPulse 2.0
Patients are given OrthoPulse 2.0, an extended OrthoPulse device with no zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.
Device: Invisalign 3.5 Day Wear
Patients are are fitted with sets of clear orthodontic Aligners by a qualified Principal Investigator (PI) using a ClinCheck plan by Align Technology. Aligners are worn for approximately 22 hours a day, and switched every 3.5 days.
Experimental: I-OP2.1
Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.
Device: Invisalign 3.5 Day Wear
Patients are are fitted with sets of clear orthodontic Aligners by a qualified Principal Investigator (PI) using a ClinCheck plan by Align Technology. Aligners are worn for approximately 22 hours a day, and switched every 3.5 days.
Device: OrthoPulse 2.1
Patients are given OrthoPulse 2.1, an extended OrthoPulse device with zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.
Experimental: F-OP2.0
Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
Device: OrthoPulse 2.0
Patients are given OrthoPulse 2.0, an extended OrthoPulse device with no zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.
Device: Fixed Orthodontic Appliances (Braces)
Patients are fitted with a set of brackets and wires, as per standard orthodontic treatment by a qualified Principal Investigator (PI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feedback on general experience
Time Frame: Through Study Completion, approx. 2 years
Assess doctor and patient feedback on the general experience with OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system.
Through Study Completion, approx. 2 years
Feedback on clinical performance
Time Frame: Through Study Completion, approx. 2 years
Assess doctor subjective and objective feedback on the clinical performance of OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system.
Through Study Completion, approx. 2 years
Adverse events
Time Frame: Through Study Completion, approx. 2 years
Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1
Through Study Completion, approx. 2 years

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 (Actual)

December 22, 2017

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BX13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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