Clinical Trial: OrthoPulse™ Product Evaluation and Assessing Clinical Effectiveness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: OrthoPulse™ Product Evaluation and Assessing Clinical Effectiveness

Brief Summary: The purpose of this investigation is to evaluate the clinical effectiveness of the OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, and for investigators to evaluate the product in a clinical setting.

Detailed Summary:
Sponsor: Biolux Research Ltd.

Current Primary Outcome: Overall orthodontic treatment time for OrthoPulse™ treated patients. [ Time Frame: 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. ]

The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.


Original Primary Outcome: To observe the overall orthodontic treatment time for patients receiving daily OrthoPulse™ treatment. [ Time Frame: 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. ]

The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.


Current Secondary Outcome:

  • Patient satisfaction with using OrthoPulse™. [ Time Frame: 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. ]
    Patients will complete two different questionnaires near the start and at the end of their orthodontic treatment. Every question may only be answered by means of a quantitative 1-3 rated scale, resulting in measurable responses.
  • Orthodontist satisfaction with implementing OrthoPulse™ into their practice. [ Time Frame: 6 months after starting the first patient until the last patient has finished their orthodontic treatment, estimated to be around 3 years. ]
    Orthodontists will complete a questionnaire when each case is complete as well as a questionnaire every 6 months after starting the first patient. Every question may only be answered by means of a quantitative 1-3 rated scale, resulting in measurable responses.


Original Secondary Outcome:

  • To evaluate patient satisfaction with using OrthoPulse™. [ Time Frame: 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. ]
    Patients will complete two different questionnaires near the start and at the end of their orthodontic treatment. Every question may only be answered by means of a quantitative 1-3 rated scale, resulting in measurable responses.
  • To evaluate orthodontist satisfaction with implementing OrthoPulse™ into their practice. [ Time Frame: 6 months after starting the first patient until the last patient has finished their orthodontic treatment, estimated to be around 3 years. ]
    Orthodontists will complete a questionnaire when each case is complete as well as a questionnaire every 6 months after starting the first patient. Every question may only be answered by means of a quantitative 1-3 rated scale, resulting in measurable responses.


Information By: Biolux Research Ltd.

Dates:
Date Received: October 10, 2014
Date Started: October 2013
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016