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This investigational testing aims to target multiple investigations sites to examine treatment efficiency metrics using a completely digital and patient-specific bracket treatment system for the correction of malocclusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Malocclusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LightForce Orthodontic System | Device | The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Bonding Appointment | 1 day | |
| Number of Debonded Brackets | approximately 2 years | |
| Length of Treatment | approximately 2 years | |
| Length of Debond Appointment | 1 day | |
| Length of Time to Achieve Leveling and Aligning | 2 years | |
| Number of Unscheduled Appointments | 2 years | |
| Number of Repositioned Brackets | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelsey Fafara, BS | LightForce Orthodontics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walt Orthodontics | Maple | Ontario | L6A 0A9 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Malocclusion | LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline metrics were not taken for the study population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Malocclusion | LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion |
| 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 | Length of Bonding Appointment | Posted | Mean | Standard Deviation | minutes | 1 day |
|
|
Patients were evaluated for any adverse events over their treatment, an expected average of 2 years. However, two patients had treatment times over 2 years with the maximum being under 4 years/
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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 | Patients With Malocclusion | LightForce Orthodontic System: The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Fafara | LightForce Orthodontics | 7329775646 | kelsey@lightforceortho.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2019 | Jan 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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 |
|
| Time to Bond | Data was not collected for patients at a baseline | Data was not collected for patients at a baseline | Mean | Standard Deviation | Minutes |
|
| Length of treatment | Data was not collected for patients at a baseline | Data was not collected for patients at a baseline | Mean | Standard Deviation | months |
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| length of debonding appointment | Data was not collected for patients at a baseline | Data was not collected for patients at a baseline | Mean | Standard Deviation | Minutes |
|
| length of time to achieve level and align | Data was not collected for patients at a baseline | Data was not collected for patients at a baseline | Mean | Standard Deviation | months |
|
| number of unscheduled appointments | Data was not collected for patients at a baseline | Mean | Standard Deviation | number of brackets |
|
| Number of repositioned brackets | Data was not collected for patients at a baseline | Mean | Standard Deviation | number of brackets |
|
|
| Primary | Number of Debonded Brackets | One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists. | Posted | Mean | Standard Deviation | number of brackets | approximately 2 years |
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| Primary | Length of Treatment | One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists. | Posted | Mean | Standard Deviation | months | approximately 2 years |
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| Primary | Length of Debond Appointment | One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists. | Posted | Mean | Standard Deviation | minutes | 1 day |
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| Primary | Length of Time to Achieve Leveling and Aligning | One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists. | Posted | Mean | Standard Deviation | months | 2 years |
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| Primary | Number of Unscheduled Appointments | One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists. | Posted | Mean | Standard Deviation | number of appointments | 2 years |
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| Primary | Number of Repositioned Brackets | One patient did not complete treatment as they moved out of town and no longer went to the study's orthodontists. | Posted | Mean | Standard Deviation | number of brackets | 2 years |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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