Effect of VPro5 Therapy on Clear Aligner Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Other: Deviation from Standard Tray Wear Time (14 Days); Device: VPro5 device

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hoboken, New Jersey, United States, 07030
      • CTOR
    • Hoboken, New Jersey, United States, 07030
      • Orthodontia Studio
  • New York
    • Brooklyn, New York, United States, 11201
      • House of Orthodontia
  • Texas
    • San Antonio, Texas, United States, 78259
      • Atique Orthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 14 Day Tray + Sham; Trays worn at 14 day intervals + Sham
Experimental: 7 Day Tray + Sham; Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham	Other: Deviation from Standard Tray Wear Time (14 Days); Patients reduced Tray Wear Time Interval (14 Days)
Experimental: 5 Day Tray + Sham; Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham	Other: Deviation from Standard Tray Wear Time (14 Days); Patients reduced Tray Wear Time Interval (14 Days)
Experimental: 7 Day Tray + VPro5; Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day	Other: Deviation from Standard Tray Wear Time (14 Days); Patients reduced Tray Wear Time Interval (14 Days); Device: VPro5 device; Use of the VPro5 device for 5 minutes a day
Experimental: 5 Day Tray + VPro5; Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day	Other: Deviation from Standard Tray Wear Time (14 Days); Patients reduced Tray Wear Time Interval (14 Days); Device: VPro5 device; Use of the VPro5 device for 5 minutes a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Aligner Tracking Percentage	Average assessed via measurement of intraoral scan and prediction software	Through study completion, average of 25 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Cytokine Levels	Through study completion, average of 25 days
Pain Perception via Numerical Rating Scale	Day 1 and Day 3 of each aligner

Collaborators and Investigators

• Sponsor: Mani Alikhani
• Collaborators: Propel Orthodontics, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2017
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: HFA; HFV; High Frequency Vibration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: VPro5 + Aligners

Drug and device information, study documents

• 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