Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2017-02-03
2017-07-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimizing Aligner Wear Time and Change Frequency
NCT04260633
Predictability of Part-time Wearing of Removable Clear Aligner Therapy Versus Full Time
NCT06253286
Influence of Injectable Platelet Rich Fibrin on Different Orthodontic Tooth Movements During Clear Aligner Therapy
NCT06380946
Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements During Clear Aligner Therapy
NCT06276985
Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol
NCT05905224
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
14 Day Tray + Sham
Trays worn at 14 day intervals + Sham
No interventions assigned to this group
7 Day Tray + Sham
Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days))
\+ Sham
Deviation from Standard Tray Wear Time (14 Days)
Patients reduced Tray Wear Time Interval (14 Days)
5 Day Tray + Sham
Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days))
\+ Sham
Deviation from Standard Tray Wear Time (14 Days)
Patients reduced Tray Wear Time Interval (14 Days)
7 Day Tray + VPro5
Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days))
\+ HFV with the VPro5 device at 5 min/day
VPro5 device
Use of the VPro5 device for 5 minutes a day
Deviation from Standard Tray Wear Time (14 Days)
Patients reduced Tray Wear Time Interval (14 Days)
5 Day Tray + VPro5
Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days))
\+ HFV with the VPro5 device at 5 min/day
VPro5 device
Use of the VPro5 device for 5 minutes a day
Deviation from Standard Tray Wear Time (14 Days)
Patients reduced Tray Wear Time Interval (14 Days)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VPro5 device
Use of the VPro5 device for 5 minutes a day
Deviation from Standard Tray Wear Time (14 Days)
Patients reduced Tray Wear Time Interval (14 Days)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Propel Orthodontics, LLC
INDUSTRY
Mani Alikhani
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mani Alikhani
Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VPro5 + Aligners
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.