Effect of VPro5 Therapy on Clear Aligner Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Malocclusion

Intervention / Treatment
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* Device: VPro5 device
* Other: Deviation from Standard Tray Wear Time (14 Days)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 14 Day Tray + Sham<br>Trays worn at 14 day intervals + Sham | |
| Experimental: 7 Day Tray + Sham<br>Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham | Other: Deviation from Standard Tray Wear Time (14 Days)<br>* Patients reduced Tray Wear Time Interval (14 Days)<br>|
| Experimental: 5 Day Tray + Sham<br>Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham | Other: Deviation from Standard Tray Wear Time (14 Days)<br>* Patients reduced Tray Wear Time Interval (14 Days)<br>|
| Experimental: 7 Day Tray + VPro5<br>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 device<br>* Use of the VPro5 device for 5 minutes a day<br>Other: Deviation from Standard Tray Wear Time (14 Days)<br>* Patients reduced Tray Wear Time Interval (14 Days)<br>|
| Experimental: 5 Day Tray + VPro5<br>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 device<br>* Use of the VPro5 device for 5 minutes a day<br>Other: Deviation from Standard Tray Wear Time (14 Days)<br>* Patients reduced Tray Wear Time Interval (14 Days)<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFV, HFA, High Frequency Vibration