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
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UNKNOWN
NA
85 participants
INTERVENTIONAL
2020-03-01
2021-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1
22-hour tray wear time, DM assisted aligner change frequency
No interventions assigned to this group
Group 2
22-hour tray wear time, VPro+ (active), DM assisted aligner change frequency
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.
Group 3
22-hour tray wear time, VPro+ (inactive), DM assisted aligner change frequency
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.
Group 4
12-hour tray wear time, VPro+ (active), DM assisted aligner change frequency
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.
Group 5
12-hour tray wear time, VPro+ (inactive), DM assisted aligner change frequency
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
Exclusion:
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Harvard School of Dental Medicine
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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IRB19-0644
Identifier Type: -
Identifier Source: org_study_id
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