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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • 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

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
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

What is the study measuring?

Primary Outcome Measures

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

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

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)

January 8, 2020

Primary Completion (ACTUAL)

June 24, 2020

Study Completion (ACTUAL)

June 24, 2020

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (ACTUAL)

May 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID 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.

Clinical Trials on Orthodontic Tooth Movement

Clinical Trials on Intervention 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe