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. ]
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. ]
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