NCT03240770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

July 28, 2017

Last Update Submit

August 2, 2017

Conditions

Malocclusion

Keywords

HFVHFAHigh Frequency Vibration

Outcome Measures

Primary Outcomes (1)

  • Average Aligner Tracking Percentage

    Average assessed via measurement of intraoral scan and prediction software

    Through study completion, average of 25 days

Secondary Outcomes (2)

  • Cytokine Levels

    Through study completion, average of 25 days

  • Pain Perception via Numerical Rating Scale

    Day 1 and Day 3 of each aligner

Study Arms (5)

14 Day Tray + Sham

NO INTERVENTION

Trays worn at 14 day intervals + Sham

7 Day Tray + Sham

EXPERIMENTAL

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

Other: Deviation from Standard Tray Wear Time (14 Days)

5 Day Tray + Sham

EXPERIMENTAL

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

Other: Deviation from Standard Tray Wear Time (14 Days)

7 Day Tray + VPro5

EXPERIMENTAL

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

Device: VPro5 deviceOther: Deviation from Standard Tray Wear Time (14 Days)

5 Day Tray + VPro5

EXPERIMENTAL

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

Device: VPro5 deviceOther: Deviation from Standard Tray Wear Time (14 Days)

Interventions

VPro5 deviceDEVICE

Use of the VPro5 device for 5 minutes a day

5 Day Tray + VPro57 Day Tray + VPro5
Deviation from Standard Tray Wear Time (14 Days)OTHER

Patients reduced Tray Wear Time Interval (14 Days)

5 Day Tray + Sham5 Day Tray + VPro57 Day Tray + Sham7 Day Tray + VPro5

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CTOR

Hoboken, New Jersey, 07030, United States

Location

Orthodontia Studio

Hoboken, New Jersey, 07030, United States

Location

House of Orthodontia

Brooklyn, New York, 11201, United States

Location

Atique Orthodontics

San Antonio, Texas, 78259, United States

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 7, 2017

Study Start

February 3, 2017

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

August 7, 2017

Record last verified: 2017-08

Locations

US(4)