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Effect of VPro5 Therapy on Clear Aligner Therapy

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VPro5 device
Deviation from Standard Tray Wear Time (14 Days)
Sponsored by
Mani Alikhani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring HFV, HFA, High Frequency Vibration

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subjects who have received periodontal treatment in the previous 6 months
  2. 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.
  3. Subjects missing adult teeth (except the 3rd molars) or with severe class II or class III malocclusion.
  4. Subjects with skeletal class I but extreme dental malocclusion
  5. Severe crowding that require extraction
  6. More than 4 mm positive overjet and more than 2 mm negative overjet
  7. Extreme deep bite (more than 90%);
  8. Severe openbite (more than 2 mm)
  9. Pregnant women
  10. Subjects do not have any systemic diseases effecting bone metabolism
  11. Smoking
  12. Vulnerable subjects per IRB definitions
  13. Subjects with current caries
  14. Subjects that require interproximal reduction or attachments during the study period
  15. Subjects who are non-compliant regarding aligner wear or VPro5 recommended daily usage

Sites / Locations

  • CTOR
  • Orthodontia Studio
  • House of Orthodontia
  • Atique Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

14 Day Tray + Sham

7 Day Tray + Sham

5 Day Tray + Sham

7 Day Tray + VPro5

5 Day Tray + VPro5

Arm Description

Trays worn at 14 day intervals + Sham

Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham

Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham

Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day

Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day

Outcomes

Primary Outcome Measures

Average Aligner Tracking Percentage
Average assessed via measurement of intraoral scan and prediction software

Secondary Outcome Measures

Cytokine Levels
Pain Perception via Numerical Rating Scale

Full Information

First Posted
July 28, 2017
Last Updated
August 2, 2017
Sponsor
Mani Alikhani
Collaborators
Propel Orthodontics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03240770
Brief Title
Effect of VPro5 Therapy on Clear Aligner Therapy
Official Title
Effect of VPro5 Therapy on Clear Aligner Tracking: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mani Alikhani
Collaborators
Propel Orthodontics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
HFV, HFA, High Frequency Vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
14 Day Tray + Sham
Arm Type
No Intervention
Arm Description
Trays worn at 14 day intervals + Sham
Arm Title
7 Day Tray + Sham
Arm Type
Experimental
Arm Description
Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham
Arm Title
5 Day Tray + Sham
Arm Type
Experimental
Arm Description
Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham
Arm Title
7 Day Tray + VPro5
Arm Type
Experimental
Arm Description
Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day
Arm Title
5 Day Tray + VPro5
Arm Type
Experimental
Arm Description
Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day
Intervention Type
Device
Intervention Name(s)
VPro5 device
Intervention Description
Use of the VPro5 device for 5 minutes a day
Intervention Type
Other
Intervention Name(s)
Deviation from Standard Tray Wear Time (14 Days)
Intervention Description
Patients reduced Tray Wear Time Interval (14 Days)
Primary Outcome Measure Information:
Title
Average Aligner Tracking Percentage
Description
Average assessed via measurement of intraoral scan and prediction software
Time Frame
Through study completion, average of 25 days
Secondary Outcome Measure Information:
Title
Cytokine Levels
Time Frame
Through study completion, average of 25 days
Title
Pain Perception via Numerical Rating Scale
Time Frame
Day 1 and Day 3 of each aligner

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CTOR
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States
Facility Name
Orthodontia Studio
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States
Facility Name
House of Orthodontia
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Atique Orthodontics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78259
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effect of VPro5 Therapy on Clear Aligner Therapy

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