Effect of VPro5 Therapy on Clear Aligner Therapy

Completed · Not applicable · Has a placebo group

Conditions studied: Malocclusion

In brief

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.

Key facts

Study ID

NCT03240770

Run by

Mani Alikhani

People needed

60

Starts

2017-02-03

Expected to finish

2017-07-20

Last updated by the study team

2017-08-07

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• CTOR — Hoboken, New Jersey, United States
• Orthodontia Studio — Hoboken, New Jersey, United States
• House of Orthodontia — Brooklyn, New York, United States
• Atique Orthodontics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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