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Effect of VPro5 Therapy on Clear Aligner Therapy

NCT03240770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-08-07

No results posted yet for this study

Summary

The investigators hypothesize that brief, daily application of HFA will increase the efficiency of clear aligner treatment by altering PDL metabolism without increasing pain or discomfort. The investigators will divide subjects into 5 groups changing clear aligners at different time intervals with or without HFA application for 5 minutes/day to assess the effect on: time intervals between aligners, cytokine activity, and pain perception.

Conditions

  • Malocclusion

Interventions

DEVICE

VPro5 device

Use of the VPro5 device for 5 minutes a day

OTHER

Deviation from Standard Tray Wear Time (14 Days)

Patients reduced Tray Wear Time Interval (14 Days)

Sponsors & Collaborators

  • Propel Orthodontics, LLC

    collaborator INDUSTRY

  • Mani Alikhani

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-03
Primary Completion
2017-07-20
Completion
2017-07-20
FDA Device
Yes

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 NCT03240770 on ClinicalTrials.gov