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OpenTrials
Completed

NCT Number: NCT03240770

Effect of VPro5 Therapy on Clear Aligner Therapy

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CTOR, Hoboken, New Jersey, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be 18 - 45 years of age
  • Subject is willing and able to comply with all study procedures and sign Informed consent/HIPAA forms
  • Subject must have complete adult dentition (excluding third molars)
  • Subjects must have class I malocclusion or mild class II/III malocclusions
  • Subject is at least one month into aligner treatment.
  • Subject has history of and current healthy oral hygiene (PD is<4mm, GI<1, and PI=1)

Exclusion criteria

  • Subjects who have received periodontal treatment in the previous 6 months
  • Subjects who are taking medication that could affect the level of inflammation, such as chronic antibiotics, phenytoin, cyclosporin, ant-inflammatory drugs, systemic corticosteroids, or calcium channel blockers.
  • Subjects missing adult teeth (except the 3rd molars) or with severe class II or class III malocclusion.
  • Subjects with skeletal class I but extreme dental malocclusion
  • Severe crowding that require extraction
  • More than 4 mm positive overjet and more than 2 mm negative overjet
  • Extreme deep bite (more than 90%);
  • Severe openbite (more than 2 mm)
  • Pregnant women
  • Subjects do not have any systemic diseases effecting bone metabolism
  • Smoking
  • Vulnerable subjects per IRB definitions
  • Subjects with current caries
  • Subjects that require interproximal reduction or attachments during the study period
  • Subjects who are non-compliant regarding aligner wear or VPro5 recommended daily usage

Treatment and study plan

VPro5 device

Device

Use of the VPro5 device for 5 minutes a day

Deviation from Standard Tray Wear Time (14 Days)

Other

Patients reduced Tray Wear Time Interval (14 Days)

Primary outcomes

  1. Average Aligner Tracking Percentage

    Time frame: Through study completion, average of 25 days

    Average assessed via measurement of intraoral scan and prediction software

Secondary outcomes

  1. Cytokine Levels

    Time frame: Through study completion, average of 25 days

  2. Pain Perception via Numerical Rating Scale

    Time frame: Day 1 and Day 3 of each aligner

Sponsors and collaborators

Lead sponsor

Mani Alikhani

Industry

Collaborators

  • Propel Orthodontics, LLC

Registry information

Official study title

Effect of VPro5 Therapy on Clear Aligner Tracking: a Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 7, 2017
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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