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

NCT04386278 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-11-23

No results posted yet for this study

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.

Conditions

  • Orthodontic Tooth Movement

Interventions

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

Sponsors & Collaborators

  • Biolux Research Holdings, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-08
Primary Completion
2020-06-24
Completion
2020-06-24

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04386278 on ClinicalTrials.gov