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| ID | Type | Description | Link |
|---|---|---|---|
| ORTHO2011-01 | Other Identifier | University of Tennessee |
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| Name | Class |
|---|---|
| University of Tennessee | OTHER |
| 3M | INDUSTRY |
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Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.
To determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediagel | Active Comparator | 1.23% Acidulated Phosphate Fluoride Gel |
|
| 3M Vanish Varnish | Experimental | 5% sodium fluoride varnish |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanish Varnish | Device | 5% sodium fluoride varnish with tricalcium phosphate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison | Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization. | Baseline, Three and Six Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franklin Garcia-Godoy, DDS, MS | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry | Memphis | Tennessee | 38163 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediagel | 1.23% Acidulated Phosphate Fluoride Gel (Preventech) |
| FG001 | Vanish Varnish | 5% sodium fluoride varnish with tricalcium phosphate (3M) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pediagel | 1.23% Acidulated Phosphate Fluoride Gel |
| BG001 | Vanish Varnish | 5% sodium fluoride varnish with tricalcium phosphate |
| 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 | DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison | Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Three and Six Month | Teeth | Teeth |
|
Six Months
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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 | Group 2 | Oral B Minute-Gel, fluoride gel Oral B Minute-Gel: Fluoride gel | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franklin Garcia-Godoy DDDS, MS PhD | University of Health Science Center | fgarciagodoy@gmail.com |
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| Pediagel |
| Device |
1.23% Acidulated Phosphate Fluoride Gel |
|
| BG002 | Total | Total of all reporting groups |
| Teeth |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
| Teeth |
|
|
|
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Group 1 | Vanish varnish, 5% sodium fluoride varnish with tricalcium phosphate Vanish varnish: 5% sodium fluoride varnish with tricalcium phosphate | 0 | 19 | 0 | 19 | 0 | 19 |
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