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

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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.

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE May 13, 2020
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE January 8, 2020
Actual Primary Completion Date June 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2020)
  • 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).
  • 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
  • Initial Safety of Device [ Time Frame: From enrolment to study completion, anticipated six (6) months ]
    Confirmation of safety through collection of adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)
Official Title  ICMJE RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Orthodontic Tooth Movement
Intervention  ICMJE
  • Device: Intervention 1
    Side one: No treatment 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
  • Device: Intervention 3
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
  • Device: Intervention 4
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
  • Device: Intervention 5
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
  • Device: Intervention 6
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
  • Device: Intervention 7
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
  • Device: Intervention 8
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes
Study Arms  ICMJE
  • Experimental: Intervention 1
    Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
    Intervention: Device: Intervention 1
  • Experimental: Intervention 2
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
    Intervention: Device: Intervention 2
  • Experimental: Intervention 3
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
    Intervention: Device: Intervention 3
  • Experimental: Intervention 4
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
    Intervention: Device: Intervention 4
  • Experimental: Intervention 5
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
    Intervention: Device: Intervention 5
  • Experimental: Intervention 6
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
    Intervention: Device: Intervention 6
  • Experimental: Intervention 7
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
    Intervention: Device: Intervention 7
  • Experimental: Intervention 8
    Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
    Intervention: Device: Intervention 8
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 8, 2020)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 24, 2020
Actual Primary Completion Date June 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04386278
Other Study ID Numbers  ICMJE RI.2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biolux Research Holdings, Inc.
Study Sponsor  ICMJE Biolux Research Holdings, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biolux Research Holdings, Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP