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The AcceleDent® device has been introduced to the specialty of orthodontics in order to reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth movement to occur more quickly.
Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort during orthodontic treatment.
This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.
This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Vibration | Experimental | Use of Active Vibration (AcceleDent device) 20 minutes each day during treatment with aligners |
|
| Sham Vibration | Active Comparator | Use of Sham Vibration (Sham AcceleDent device) 20 minutes each day during treatment with aligners |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcceleDent, Vibrational Device | Device | 20 minutes of vibration each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura) | The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Final Alignment Scores of the Upper and Lower Incisors | Final alignment was measured using Little's incisor irregularity index. This index sums the displacement of the contact points of the anterior teeth, to produce a millimetric number. The lower the score, the more perfect the alignment. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Huang | UW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cohanim Smileworks | Seattle | Washington | 981122 | United States | ||
| Dr. Sandra Tai |
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| ID | Title | Description |
|---|---|---|
| FG000 | A (Active Device) | 20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units This groups received Active Devices with frequency of 30Hz ( revealed after study completion ) |
| FG001 | B (Control Device) | 20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units This group received control devices with frequency of 0 Hz ( revealed after study completion ) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A (Active Device) | 20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units |
| BG001 | B (Control Device) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura) | The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners. | The outcome was the ability to complete the initial set of aligners | Posted | Count of Participants | Participants | 6 months |
|
We collected adverse events data for each patient from the time they began their first aligner until they completed their last aligner, or until they exited the study for some other reason. These periods of time were individual to each patient, as they each had a unique number of aligners, and could have also exited the study if they were not progressing based on the a priori criteria.
We were not expecting any mortality or serious adverse events from the use of the vibrational device. We were monitoring for any other adverse events, like shortening of tooth roots or pain associated with tooth movement. However, we can report that we monitored all patients during the period of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A (Active Device) | 20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units |
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The number of aligners in the upper and lower arches for each patient were made equivalent, in order to end tooth movement at the same time in both arches.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Greg Huang, Professor and Chair of Orthodontics | University of Washington | (206) 616-6996 | ghuang@uw.edu |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Richmond |
| British Columbia |
| V7C 5L9 |
| Canada |
| Dr. Sandra Tai | Vancouver | British Columbia | V5H 4K7 | Canada |
20 minutes daily usage in conjunction with orthodontic treatment with clear aligners
AcceleDent, Vibrational Device: Participants will receive one of two vibrational units
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
20 minutes daily usage of a placebo vibration device
|
|
| Secondary | Final Alignment Scores of the Upper and Lower Incisors | Final alignment was measured using Little's incisor irregularity index. This index sums the displacement of the contact points of the anterior teeth, to produce a millimetric number. The lower the score, the more perfect the alignment. | Final incisor irregularity, measured in millimeters | Posted | Mean | Standard Deviation | Little's irregularity index (mm) | 6 months |
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|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | B (Control Device) | 20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units | 0 | 13 | 0 | 13 | 0 | 13 |
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