Effect of VPro5 Therapy on Clear Aligner Therapy

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240770
• Other study ID #: VPro5 + Aligners
• Status: Completed
• Phase: N/A
• First received: July 28, 2017
• Last updated: August 2, 2017
• Start date: February 3, 2017
• Est. completion date: July 20, 2017

Study information

• Verified date: August 2017
• Source: Consortium for Translational Orthodontic Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

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)

Locations

Country	Name	City	State
United States	House of Orthodontia	Brooklyn	New York
United States	CTOR	Hoboken	New Jersey
United States	Orthodontia Studio	Hoboken	New Jersey
United States	Atique Orthodontics	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Mani Alikhani	Propel Orthodontics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Aligner Tracking Percentage	Average assessed via measurement of intraoral scan and prediction software	Through study completion, average of 25 days
Secondary	Cytokine Levels		Through study completion, average of 25 days
Secondary	Pain Perception via Numerical Rating Scale		Day 1 and Day 3 of each aligner