Malocclusion
Conditions
Keywords
Orthodontic, Extraction, Device, Space Closure, Orthodontic malocclusion
Brief summary
To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces).
Detailed description
This is a randomized, blinded study that will follow 32 patients for up to six months. Patients will have a minimum of 3 mm of extraction space that needs to be closed by moving the anterior teeth or canine distally. Patients will have standard orthodontic treatment and temporary anchorage devices for tooth movement and space closure. Half the patients will receive a functioning device and half the patients will receive a sham-device. Patients will use the device for 20 minutes daily; the device has a mouthpiece for the patient to lightly bite into plus a connected enclosure that stays outside the mouth. The enclosure provides a light vibration.
Interventions
DEVICEOrthoAccel Device
The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
DEVICESham Device
Inactive sham device that is held in the mouth for 20 minutes.
Sponsors
OrthoAccel Technologies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Permanent dentition between the ages of 12 and 40 * Minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines * Good oral hygiene and compliance
Exclusion criteria
* Any compromised medical or dental condition * Patient currently involved in any other study * Lives significantly outside San Antonio, TX * use of bisphosphonates * pregnant females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space. | Time to Space Closure, an average of 22 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OrthoAccel Device OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily. | 23 |
| Sham (Inactive Device) Sham Device : Inactive sham device that is held in the mouth for 20 minutes. | 22 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | OrthoAccel Device | Sham (Inactive Device) | Total |
|---|---|---|---|
| Age Continuous | 21.8 years STANDARD_DEVIATION 8.7 | 21.4 years STANDARD_DEVIATION 7.8 | 21.6 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 6 Participants | 11 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 23 | 5 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
Primary
The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.
Time frame: Time to Space Closure, an average of 22 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OrthoAccel Device | The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space. | 0.27 mm/week | Standard Deviation 0.04 |
| Sham (Inactive Device) | The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space. | 0.18 mm/week | Standard Deviation 0.04 |