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The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

NCT02954133 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2019-01-15

No results posted yet for this study

Summary

The aim of the study is to determine if, and to what degree photobiomodulation treatment with OrthoPulse has an effect on the rate of tooth movement during alignment for patients receiving Invisalign orthodontic aligner treatment.

Conditions

  • Malocclusion

Interventions

DEVICE

Invisalign (7 day)

Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 7 days.

DEVICE

Invisalign (5 day)

Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 5 days.

DEVICE

OrthoPulse

Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.

DEVICE

Invisalign (3.5 day)

Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 3.5 days.

Sponsors & Collaborators

  • Biolux Research Holdings, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Brawn, DDS · Biolux Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • United States

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 NCT02954133 on ClinicalTrials.gov