Status:
COMPLETED
Effect of VPro5 Therapy on Clear Aligner Therapy
Lead Sponsor:
Mani Alikhani
Collaborating Sponsors:
Propel Orthodontics, LLC
Conditions:
Malocclusion
Eligibility:
All Genders
18-45 years
Phase:
NA
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 investi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03240770
Start Date
February 3 2017
End Date
July 20 2017
Last Update
August 7 2017
Active Locations (4)
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1
CTOR
Hoboken, New Jersey, United States, 07030
2
Orthodontia Studio
Hoboken, New Jersey, United States, 07030
3
House of Orthodontia
Brooklyn, New York, United States, 11201
4
Atique Orthodontics
San Antonio, Texas, United States, 78259