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OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386278
Recruitment Status : Terminated (Study stopped because slow enrolment.)
First Posted : May 13, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Biolux Research Holdings, Inc.

Study Description
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Brief Summary:

This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Intrusion and extrusion will be conducted using bilaterally equivalent elastomeric forces of 50 grams.

A comparison of the rate of bilateral orthodontic tooth movement will be conducted using six (6) varied photobiomodulation interventions on the maxillary (upper) and mandibular (lower) arches. The OrthoPulse Gen 2 and OrthoPulse (commercially approved) devices are being used in this clinical investigation. Each subject enrolled will go through intrusion and extrusion.

All subjects will be allocated to an OrthoPulse split-mouth intervention by the investigator.


Condition or disease Intervention/treatment Phase
Orthodontic Tooth Movement Device: Intervention 1 Device: Intervention 2 Device: Intervention 3 Device: Intervention 4 Device: Intervention 5 Device: Intervention 6 Device: Intervention 7 Device: Intervention 8 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Each group in this study includes a different device iteration that is being investigated in parallel.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical
Actual Study Start Date : January 8, 2020
Actual Primary Completion Date : June 24, 2020
Actual Study Completion Date : June 24, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention 1
Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
 Device: Intervention 1
Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
Experimental: Intervention 2
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
 Device: Intervention 2
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
Experimental: Intervention 3
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
 Device: Intervention 3
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
Experimental: Intervention 4
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
 Device: Intervention 4
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
Experimental: Intervention 5
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
 Device: Intervention 5
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Experimental: Intervention 6
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
 Device: Intervention 6
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
Experimental: Intervention 7
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
 Device: Intervention 7
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Experimental: Intervention 8
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
 Device: Intervention 8
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes


Outcome Measures
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Primary Outcome Measures :
  1. The rate of orthodontic tooth movement [ Time Frame: 36 days (±12 days) from T0 visit ]
    The rate of orthodontic tooth movement during intrusion at 36 days (±12 days) from the T0 Visit (measured in mm per week).


Secondary Outcome Measures :
  1. Peak Pain: Questionnaire [ Time Frame: 7 Days ]
    Assess peak pain experienced over first seven (7) days of treatment during intrusion using a questions similar in nature to a Visual Analog Scale (subject to complete pain questionnaire).

  2. Root Resorption [ Time Frame: 36 days (±12 days) from T0 visit ]
    Assess tooth resorption by measuring the root length of the first or second bicuspid bilaterally from baseline to T3

  3. Initial Safety of Device [ Time Frame: From enrolment to study completion, anticipated six (6) months ]
    Confirmation of safety through collection of adverse events


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient must be 19 years of age or older
  • Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning
  • Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data

Exclusion Criteria:

  • Patient is currently enrolled in another clinical study
  • Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion
  • Periodontally involved teeth, acute oral infection or periodontal disease
  • Patient has active/untreated caries
  • Use of bisphosphonates at any time
  • Use of drugs that may cause photosensitivity
  • History of photosensitivity
  • Epilepsy
  • Pregnant or planning pregnancy during the study.
  • Patient plans to relocate over the treatment period
Contacts and Locations
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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): NCT04386278


Locations
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Canada, B.C
Dr. Peter Brawn
Vancouver, B.C, Canada, V6A 4G8
Sponsors and Collaborators
Biolux Research Holdings, Inc.
More Information
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Responsible Party: Biolux Research Holdings, Inc.
ClinicalTrials.gov Identifier: NCT04386278    
Other Study ID Numbers: RI.2
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No