Effect of VPro5 Therapy on Clear Aligner Therapy

Mani Alikhani

Status: Completed

Conditions: Malocclusion

Treatments: Other: Deviation from Standard Tray Wear Time (14 Days); Device: VPro5 device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03240770

VPro5 + Aligners

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 5 patient groups

14 Day Tray + Sham

No Intervention group

Description:

Trays worn at 14 day intervals + Sham

7 Day Tray + Sham

Experimental group

Description:

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

Treatment:

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

5 Day Tray + Sham

Experimental group

Description:

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

Treatment:

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

7 Day Tray + VPro5

Experimental group

Description:

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

Treatment:

Device: VPro5 device

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

5 Day Tray + VPro5

Experimental group

Description:

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

Treatment:

Device: VPro5 device

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