Adjunctive Usage of Vibrational TherapyNCT04260633
Optimizing Aligner Wear Time and Change Frequency
A study testing Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial. in people with Adjunctive Usage of Vibrational Therapy and Dental Monitoring Accuracy, run by Harvard School of Dental Medicine.
Trial summary
This study aims to help improve individualization and optimization of clear aligner therapy through the use of new technologies in orthodontics. The study will compare 12-hour and 22-hour tray wear time and evaluate the adjunctive use of Vpro+. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adjunctive Usage of Vibrational Therapy, Dental Monitoring Accuracy
- What is being tested?
- Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Mar 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects ages 18-65 years of age with complete adult dentition, with Class I malocclusion or mild Class II/III malocclusions who are currently in treatment.
- Subjects who do not have systemic diseases that affect orthodontic tooth movement such as patients who are using hormone replacement medications, bone diseases such as osteoporosis or hyper/hypo-thyroidism
- Periodontal probing depths (PD) < 4mm, gingival index (GI) ≤1, and plaque index (PI) ≤1
- Patients currently in orthodontic treatment with Invisalign who are currently changing their trays every 7 - 10 days
- Participant must have a smartphone that is capable of downloading and storing the Dental Monitoring application
- Participants must be able to master the use of the Dental Monitoring Application
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- Male and female subjects ages 18-65 years of age with complete adult dentition, with Class I malocclusion or mild Class II/III malocclusions who are currently in treatment.
- Subjects who do not have systemic diseases that affect orthodontic tooth movement such as patients who are using hormone replacement medications, bone diseases such as osteoporosis or hyper/hypo-thyroidism
- Periodontal probing depths (PD) < 4mm, gingival index (GI) ≤1, and plaque index (PI) ≤1
- Patients currently in orthodontic treatment with Invisalign who are currently changing their trays every 7 - 10 days
- Participant must have a smartphone that is capable of downloading and storing the Dental Monitoring application
- Participants must be able to master the use of the Dental Monitoring Application
Who cannot join
- Subjects who have within the last 6 mo taken any antibiotic medications or have had any periodontal treatments
- Subjects who have taken/are taking medications that affect bone remodeling: anti-resorptive medications, medications that may affect hormone levels, thyroid replacement medications, corticosteroids, and daily nonsteroidal anti-inflammatory medications
- Subjects who have had chemotherapy or radiation therapy in the last 6 mo
- Subjects who present with severe class II/III malocclusions
- Subjects who present with class I malocclusions but have severe crowding (> 7 mm) that requires extraction, >4 mm positive overjet and > 2 mm negative overjet, extreme deep bite ( > 90%), severe open bite (>2 mm)
- Women who are pregnant
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- Patients that smoke
- Patients with active caries
- Patients that require interproximal reduction or attachments in the remaining prescription
- Patients who have temporary anchorage devices in place
- Patients who have vertigo or issues with their temporomandibular joint
- Patients with less than 3 mo. remaining in aligner treatment
- Patients who have documented bruxism
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optimizing Aligner Wear Time and Change Frequency: A Single-Blind, Randomized Control Trial
This study aims to help improve individualization and optimization of clear aligner therapy through the use of new technologies in orthodontics. The study will compare 12-hour and 22-hour tray wear time and evaluate the adjunctive use of Vpro+. The study clinicians will use Dental Monitoring to monitor study participants throughout the trial and will use the Dental Monitoring system to instruct patients to continue or stay on their clear aligners. The outcome of the study will be the time it takes to complete 10 trays.
- Being tested
- Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.Device
The current standard of care for clear aligner use as suggested by Invisalign is unclear as to how frequently aligners should be changed. We suspect that the frequency for aligner change as determined by the orthodontist using Dental Monitoring will be variable for every participant.
Vpro+ is an adjunctive therapeutic tool for clear aligner treatment. It is proposed to deliver high frequency vibrations to reduce treatment time and pain associated with clear aligners.
Align Technology suggests 22-hour wear time for clear aligner therapy. Participants in two arms of the study will be asked to wear the trays for about half the recommended wear time to assess whether night-time aligner wear will be sufficient for successful treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | 22-hour tray wear time, DM assisted aligner change frequency |
| Group 2 | Active comparator | 22-hour tray wear time, VPro+ (active), DM assisted aligner change frequency Receives: Device: Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial. |
| Group 3 | Sham comparator | 22-hour tray wear time, VPro+ (inactive), DM assisted aligner change frequency Receives: Device: Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial. |
| Group 4 | Active comparator | 12-hour tray wear time, VPro+ (active), DM assisted aligner change frequency Receives: Device: Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial. |
| Group 5 | Sham comparator | 12-hour tray wear time, VPro+ (inactive), DM assisted aligner change frequency Receives: Device: Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete 10 trays to determine the average aligner change frequency measured at the completion of the study
Measured: 70-140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjunctive Usage of Vibrational TherapyStudies 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
- Model description
- This study will be a prospective, randomized, controlled, single-blind, parallel group clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260633
- Sponsor's protocol ID
- IRB19-0644
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Aligner Wear Time and Change Frequency: A Single-Blind, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04260633
- Acronym / sponsor ID
- IRB19-0644
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Harvard School of Dental MedicineUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 7 Feb 2020 (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.
This study aims to help improve individualization and optimization of clear aligner therapy through the use of new technologies in orthodontics. The study will compare 12-hour and 22-hour tray wear time and evaluate the adjunctive use of Vpro+. The study clinicians will use Dental Monitoring to monitor study participants throughout the trial and will use the Dental Monitoring system to instruct patients to continue or stay on their clear aligners. The outcome of the study will be the time it takes to complete 10 trays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- This study will be a prospective, randomized, controlled, single-blind, parallel group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –22-hour tray wear time, DM assisted aligner change frequency |
| Group 2 | Active comparator | Device: Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.22-hour tray wear time, VPro+ (active), DM assisted aligner change frequency |
| Group 3 | Sham comparator | Device: Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.22-hour tray wear time, VPro+ (inactive), DM assisted aligner change frequency |
| Group 4 | Active comparator | Device: Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.12-hour tray wear time, VPro+ (active), DM assisted aligner change frequency |
| Group 5 | Sham comparator | Device: Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.12-hour tray wear time, VPro+ (inactive), DM assisted aligner change frequency |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female subjects ages 18-65 years of age with complete adult dentition, with Class I malocclusion or mild Class II/III malocclusions who are currently in treatment.
- Subjects who do not have systemic diseases that affect orthodontic tooth movement such as patients who are using hormone replacement medications, bone diseases such as osteoporosis or hyper/hypo-thyroidism
- Periodontal probing depths (PD) < 4mm, gingival index (GI) ≤1, and plaque index (PI) ≤1
- Patients currently in orthodontic treatment with Invisalign who are currently changing their trays every 7 - 10 days
- Participant must have a smartphone that is capable of downloading and storing the Dental Monitoring application
Key exclusion criteria (13 listed)
- Subjects who have within the last 6 mo taken any antibiotic medications or have had any periodontal treatments
- Subjects who have taken/are taking medications that affect bone remodeling: anti-resorptive medications, medications that may affect hormone levels, thyroid replacement medications, corticosteroids, and daily nonsteroidal anti-inflammatory medications
- Subjects who have had chemotherapy or radiation therapy in the last 6 mo
- Subjects who present with severe class II/III malocclusions
- Subjects who present with class I malocclusions but have severe crowding (> 7 mm) that requires extraction, >4 mm positive overjet and > 2 mm negative overjet, extreme deep bite ( > 90%), severe open bite (>2 mm)
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 |
|---|---|---|
| Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.The current standard of care for clear aligner use as suggested by Invisalign is unclear as to how frequently aligners should be changed. We suspect that the frequency for aligner change as determined by the orthodontist using Dental Monitoring will be variable for every participant. Vpro+ is an adjunctive therapeutic tool for clear aligner treatment. It is proposed to deliver high frequency vibrations to reduce treatment time and pain associated with clear aligners. Align Technology suggests 22-hour wear time for clear aligner therapy. Participants in two arms of the study will be asked to wear the trays for about half the recommended wear time to assess whether night-time aligner wear will be sufficient for successful treatment. | Device | Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Time to complete 10 trays to determine the average aligner change frequency measured at the completion of the study
Time frame: 70-140 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial. in people with Adjunctive Usage of Vibrational Therapy and Dental Monitoring Accuracy, run by Harvard School of Dental Medicine.
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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Negin Katebi, DMSc, DDS (617-432-0577, negin_katebi@hsdm.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete 10 trays to determine the average aligner change frequency measured at the completion of the study (time frame: 70-140 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 17 Feb 2020.