Malocclusion, Tooth Movement
Conditions
Keywords
Orthodontic, Orthodontic treatment, Accelerated orthodontics, Vibration
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAcceleDent, Vibrational Device
20 minutes of vibration each day
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with malocclusions that require minor or no anterior-posterior or transverse correction in the posterior teeth, and are planned for \<= 25 aligners to complete treatment. 2. Treatment must be dual arch in order for patients to qualify for this study. 3. Patients must be 18 years or older
Exclusion criteria
1. Patients with systematic diseases or syndromes 2. Patients with a history or current use of Bisphosphonates 3. Patients with current use of nonsteroidal anti-inflammatory drugs (NSAIDs)prostaglandin inhibitors. 4. Patients with generalized moderate to severe periodontitis 5. Patients with active oral hard tissue or soft tissue lesions 6. Patients with chronic oral and maxillofacial conditions such as trigeminal neuralgia, temporomandibular disorder and orofacial pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final Alignment Scores of the Upper and Lower Incisors | 6 months | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| 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 | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | A (Active Device) | B (Control Device) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 13 Participants | 27 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 8 participants | 3 participants | 11 participants |
| Region of Enrollment United States | 6 participants | 10 participants | 16 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: 6 months
Population: The outcome was the ability to complete the initial set of aligners
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A (Active Device) | Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura) | 10 Participants |
| B (Control Device) | Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura) | 11 Participants |
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.
Time frame: 6 months
Population: Final incisor irregularity, measured in millimeters
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A (Active Device) | Final Alignment Scores of the Upper and Lower Incisors | 2.2 Little's irregularity index (mm) | Standard Deviation 0.92 |
| B (Control Device) | Final Alignment Scores of the Upper and Lower Incisors | 2.1 Little's irregularity index (mm) | Standard Deviation 0.54 |