Clinical trial NCT03240770: Effect of VPro5 Therapy on Clear Aligner Therapy
Official title: Effect of VPro5 Therapy on Clear Aligner Tracking: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: HFV
HFA
High Frequency Vibration
Lead sponsor: Consortium for Translational Orthodontic Research
Sponsor class: INDUSTRY
Collaborators: name: Propel Orthodontics, LLC
First posted: 2017-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average Aligner Tracking Percentage
timeFrame: Through study completion, average of 25 days
Secondary outcomes:
measure: Cytokine Levels
timeFrame: Through study completion, average of 25 days
measure: Pain Perception via Numerical Rating Scale
timeFrame: Day 1 and Day 3 of each aligner
Other outcomes:
Locations:
city: Hoboken
country: United States
facility: CTOR
state: New Jersey
city: Hoboken
country: United States
facility: Orthodontia Studio
state: New Jersey
city: Brooklyn
country: United States
facility: House of Orthodontia
state: New York
city: San Antonio
country: United States
facility: Atique Orthodontics
state: Texas
Study officials:
References: