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

November 19, 2020 updated by: Biolux Research Holdings, Inc.

RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • B.C
      • Vancouver, B.C, Canada, V6A 4G8
        • Dr. Peter Brawn

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
36 days (±12 days) from T0 visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
7 Days
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
36 days (±12 days) from T0 visit
Initial Safety of Device
Time Frame: From enrolment to study completion, anticipated six (6) months
Confirmation of safety through collection of adverse events
From enrolment to study completion, anticipated six (6) months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biolux Research Holdings, Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RI.2

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

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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