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To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OrthoAccel Device | Experimental | Device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily. |
|
| Sham Device (inactive device) | Sham Comparator | Sham device will look identical to active devices but will not deliver vibration to the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OrthoAccel Device | Device | The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily. |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Gakunga, DDS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ravi Anthony | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37339352 | Derived | El-Angbawi A, McIntyre G, Fleming PS, Bearn D. Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing orthodontic treatment. Cochrane Database Syst Rev. 2023 Jun 20;6(6):CD010887. doi: 10.1002/14651858.CD010887.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OrthoAccel Device | OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily. |
| FG001 | Sham (Inactive Device) | Sham Device : Inactive sham device that is held in the mouth for 20 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OrthoAccel Device | OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily. |
| BG001 | Sham (Inactive Device) | Sham Device : Inactive sham device that is held in the mouth for 20 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space. | Posted | Mean | Standard Deviation | mm/week | Time to Space Closure, an average of 22 weeks |
|
|
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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 | OrthoAccel Device | OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaestesia oral | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zaffer Syed, Director of Clinical & Regulatory Affairs | OrthoAccel Technologies, Inc. | (832) 803-0339 | zsyed@orthoaccel.com |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Sham Device | Device | Inactive sham device that is held in the mouth for 20 minutes. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 23 |
| 5 |
| 23 |
| EG001 | Sham (Inactive Device) | Sham Device : Inactive sham device that is held in the mouth for 20 minutes. | 0 | 22 | 5 | 22 |
| Nausea | Gastrointestinal disorders |
|
| Retching | Gastrointestinal disorders |
|
| Toothache | Gastrointestinal disorders |
|
| Malaise | General disorders |
|
| Sensation of pressure | General disorders |
|
| Medical device discomfort | Injury, poisoning and procedural complications |
|
| Medical device pain | Injury, poisoning and procedural complications |
|
| TAD Failure | Injury, poisoning and procedural complications |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Hypoaesthesia | Nervous system disorders |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders |
|
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