Malocclusion
Conditions
Keywords
HFV, HFA, High Frequency Vibration
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.
Interventions
DEVICEVPro5 device
Use of the VPro5 device for 5 minutes a day
OTHERDeviation from Standard Tray Wear Time (14 Days)
Patients reduced Tray Wear Time Interval (14 Days)
Sponsors
Propel Orthodontics, LLC
Mani Alikhani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Aligner Tracking Percentage | Through study completion, average of 25 days | Average assessed via measurement of intraoral scan and prediction software |
Secondary
| 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 |
Countries
United States
Outcome results
None listed