MalocclusionNCT03240770
Effect of VPro5 Therapy on Clear Aligner Therapy
A study testing VPro5 device and Deviation from Standard Tray Wear Time (14 Days) in people with Malocclusion, run by Mani Alikhani at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- VPro5 device and Deviation from Standard Tray Wear Time (14 Days)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Feb 2017to 20 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
House of Orthodontia
Brooklyn, New York, 11201
CTOR
Hoboken, New Jersey, 07030
Orthodontia Studio
Hoboken, New Jersey, 07030
Atique Orthodontics
San Antonio, Texas, 78259
About this study
Official title: Effect of VPro5 Therapy on Clear Aligner Tracking: a Randomized Clinical Trial
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.
- Conditions
- Malocclusion
- Being tested
- VPro5 device, Deviation from Standard Tray Wear Time (14 Days)
- Keywords
- HFV, HFA, High Frequency Vibration
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPro5 deviceDevice
Use of the VPro5 device for 5 minutes a day
Deviation from Standard Tray Wear Time (14 Days)Other
Patients reduced Tray Wear Time Interval (14 Days)
| Study group | Role | What they receive |
|---|---|---|
| 14 Day Tray + Sham | No intervention | Trays worn at 14 day intervals + Sham |
| 7 Day Tray + Sham | Experimental | Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days))
+ Sham Receives: Other: Deviation from Standard Tray Wear Time (14 Days) |
| 5 Day Tray + Sham | Experimental | Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days))
+ Sham Receives: Other: Deviation from Standard Tray Wear Time (14 Days) |
| 7 Day Tray + VPro5 | Experimental | Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days))
+ HFV with the VPro5 device at 5 min/day Receives: Device: VPro5 device; Other: Deviation from Standard Tray Wear Time (14 Days) |
| 5 Day Tray + VPro5 | Experimental | Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days))
+ HFV with the VPro5 device at 5 min/day Receives: Device: VPro5 device; Other: Deviation from Standard Tray Wear Time (14 Days) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Aligner Tracking Percentage
Average assessed via measurement of intraoral scan and prediction software
Measured: Through study completion, average of 25 days
Secondary outcomes (2)
Cytokine Levels
Measured: Through study completion, average of 25 days
Pain Perception via Numerical Rating Scale
Measured: Day 1 and Day 3 of each aligner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start3 Feb 2017
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mani Alikhani
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Propel Orthodontics, LLC
- Responsible party
- Sponsor-investigator, Mani Alikhani, Consortium for Translational Orthodontic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240770
- Sponsor's protocol ID
- VPro5 + Aligners
- Status last verified
- Aug 2017
- First submitted
- 28 Jul 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of VPro5 Therapy on Clear Aligner Tracking: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03240770
- Acronym / sponsor ID
- VPro5 + Aligners
- Conditions
- Malocclusion
- Keywords
- HFV, HFA, High Frequency Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mani AlikhaniIndustry (pharma, biotech, devices)
- Collaborators
- Propel Orthodontics, LLC
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 14 Day Tray + Sham | No intervention | –Trays worn at 14 day intervals + Sham |
| 7 Day Tray + Sham | Experimental | Other: Deviation from Standard Tray Wear Time (14 Days)Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham |
| 5 Day Tray + Sham | Experimental | Other: Deviation from Standard Tray Wear Time (14 Days)Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham |
| 7 Day Tray + VPro5 | Experimental | Device: VPro5 device, Other: Deviation from Standard Tray Wear Time (14 Days)Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day |
| 5 Day Tray + VPro5 | Experimental | Device: VPro5 device, Other: Deviation from Standard Tray Wear Time (14 Days)Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPro5 deviceUse of the VPro5 device for 5 minutes a day | Device | 5 Day Tray + VPro5, 7 Day Tray + VPro5 |
| Deviation from Standard Tray Wear Time (14 Days)Patients reduced Tray Wear Time Interval (14 Days) | Other | 5 Day Tray + Sham, 5 Day Tray + VPro5, 7 Day Tray + Sham, 7 Day Tray + VPro5 |
Primary outcome
Average Aligner Tracking Percentage
Time frame: Through study completion, average of 25 days
Average assessed via measurement of intraoral scan and prediction software
2 secondary outcomes
Cytokine Levels
Time frame: Through study completion, average of 25 days
Pain Perception via Numerical Rating Scale
Time frame: Day 1 and Day 3 of each aligner
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPro5 device and Deviation from Standard Tray Wear Time (14 Days) in people with Malocclusion, run by Mani Alikhani at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Aligner Tracking Percentage (time frame: Through study completion, average of 25 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.