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| Name | Class |
|---|---|
| Istanbul Medipol University Hospital | OTHER |
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The goal of this clinical trial is to evaluate the remineralizing or preservative effect of two different fluoride-containing products. The main question aims to answer how the mineral content of the active white spot lesions change after the treatment with those two fluoride applications in a split-mouth design by measuring their mineral content via QLF technology.
Each patient will receive both treatments in a split-mouth design. It is comparison between an experimental fluoride application and Fluoride Protector S.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expermental Fluoride Application | Experimental | The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one. |
|
| Fluor Protector S | Active Comparator | The ammonium fluoride gel will be applied once on the white spot lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride Application (Experimental Fluoride Application) | Device | Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Baseline |
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Baseline |
| Measurement of White Spot Lesions by QLF Parameters: WSA | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA) | Baseline |
| Measurement of White Spot Lesions by QLF Parameters: Delta Q | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions) | Baseline |
| Measurement of White Spot Lesions by QLF Parameters: Delta R | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Evaluation of the clinical status of the lesions: 0: Sound tooth surface: No evidence of caries after 5 sec air drying
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burcu Gözetici, Dr. | Istanbul Medipo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipo University | Istanbul | Esenler | 34230 | Turkey (Türkiye) |
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The recruitment period took place between February 2023 and May 2023 in the Restorative Dentistry Department of Medipol University Clinic
| ID | Title | Description |
|---|---|---|
| FG000 | Expermental Fluoride Application | The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one. Fluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done. |
| FG001 | Fluor Protector S | The ammonium fluoride gel will be applied once on the white spot lesions. Fluor Protector S: Fluor Protector S is applied on white spot lesions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Expermental Fluoride Application | The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one. Fluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Posted | Mean | Standard Deviation | percent change (%) | Baseline | Lesions | Lesions |
|
1 year
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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 | Expermental Fluoride Application | The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one. Fluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| osteosarcoma | General disorders | Non-systematic Assessment | One patient had osteosarcoma and was excluded from the study. Osteosarcoma is not related to this clinical study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Team Leader Study Management | Ivoclar Vivadent AG | +4232353780 | patrizia.elkuch-hoch@ivoclar.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 | Mar 21, 2022 | Sep 26, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000097182 | Fluoride Treatment |
| ID | Term |
|---|---|
| D005457 | Fluoridation |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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Split-mouth design: Meaning that each patient receives both treatments, but on different teeth.
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| Fluor Protector S | Device | Fluor Protector S is applied on white spot lesions. |
|
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) |
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) |
| 1 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | 1 Month |
| Measurement of White Spot Lesions by QLF Parameters: WSA | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA) | 1 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta Q | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions) | 1 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta R | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase) | 1 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | 6 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | 6 Month |
| Measurement of White Spot Lesions by QLF Parameters: WSA | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA) | 6 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta Q | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions) | 6 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta R | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase) | 6 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | 12 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | 12 Month |
| Measurement of White Spot Lesions by QLF Parameters: WSA | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA) | 12 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta Q | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions) | 12 Month |
| Measurement of White Spot Lesions by QLF Parameters: Delta R | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase) | 12 Month |
| Baseline |
| Severity and Activity of White Spot Lesions by Nyvad Criteria | Evaluation of the clinical status of the lesions: 0: Sound
| Baseline |
| Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Evaluation of the clinical status of the lesions:
| Baseline to 1 month |
| Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Evaluation of the clinical status of the lesions:
| Baseline to 1 month |
| Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Evaluation of the clinical status of the lesions:
| Baseline to 6 month |
| Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Evaluation of the clinical status of the lesions:
| Baseline to 6 month |
| Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Evaluation of the clinical status of the lesions:
| Baseline to 12 month |
| Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Evaluation of the clinical status of the lesions:
| Baseline to 12 month |
| BG001 | Fluor Protector S | The ammonium fluoride gel will be applied once on the white spot lesions. Fluor Protector S: Fluor Protector S is applied on white spot lesions. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| OG001 |
| Fluor Protector S |
The ammonium fluoride gel will be applied once on the white spot lesions. Fluor Protector S: Fluor Protector S is applied on white spot lesions. |
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Posted | Mean | Standard Deviation | percent change (%) | Baseline | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: WSA | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA) | Posted | Mean | Standard Deviation | WSA in px^2 | Baseline | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta Q | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions) | Posted | Mean | Standard Deviation | delta Q in %px | Baseline | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta R | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase) | Posted | Mean | Standard Deviation | delta R in % | Baseline | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Posted | Mean | Standard Deviation | percent change (%) | 1 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Posted | Mean | Standard Deviation | percent change (%) | 1 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: WSA | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA) | Posted | Mean | Standard Deviation | WSA in px^2 | 1 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta Q | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions) | Posted | Mean | Standard Deviation | delta Q in %px | 1 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta R | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase) | Posted | Mean | Standard Deviation | delta R in % | 1 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Posted | Mean | Standard Deviation | percent change (%) | 6 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Posted | Mean | Standard Deviation | percent change (%) | 6 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: WSA | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA) | Posted | Mean | Standard Deviation | WSA in px^2 | 6 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta Q | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions) | Posted | Mean | Standard Deviation | delta Q in %px | 6 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta R | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase) | Posted | Mean | Standard Deviation | delta R in % | 6 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Posted | Mean | Standard Deviation | percent change (%) | 12 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss) | Posted | Mean | Standard Deviation | percent change (%) | 12 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: WSA | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA) | Posted | Mean | Standard Deviation | WSA in px^2 | 12 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta Q | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions) | Posted | Mean | Standard Deviation | delta Q in %px | 12 Month | Lesions | Lesions |
|
|
|
| Primary | Measurement of White Spot Lesions by QLF Parameters: Delta R | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase) | Posted | Mean | Standard Deviation | delta R in % | 12 Month | Lesions | Lesions |
|
|
|
| Secondary | Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Evaluation of the clinical status of the lesions: 0: Sound tooth surface: No evidence of caries after 5 sec air drying
| Posted | Count of Units | lesions | Baseline | lesions | lesions |
|
|
|
| Secondary | Severity and Activity of White Spot Lesions by Nyvad Criteria | Evaluation of the clinical status of the lesions: 0: Sound
| Posted | Count of Units | lesions | Baseline | lesions | lesions |
|
|
|
| Secondary | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Evaluation of the clinical status of the lesions:
| Posted | Count of Units | lesions | Baseline to 1 month | lesions | lesions |
|
|
|
| Secondary | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Evaluation of the clinical status of the lesions:
| Posted | Count of Units | lesions | Baseline to 1 month | lesions | lesions |
|
|
|
| Secondary | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Evaluation of the clinical status of the lesions:
| Posted | Count of Units | lesions | Baseline to 6 month | lesions | lesions |
|
|
|
| Secondary | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Evaluation of the clinical status of the lesions:
| Posted | Count of Units | lesions | Baseline to 6 month | lesions | lesions |
|
|
|
| Secondary | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Evaluation of the clinical status of the lesions:
| Posted | Count of Units | lesions | Baseline to 12 month | lesions | lesions |
|
|
|
| Secondary | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Evaluation of the clinical status of the lesions:
| Posted | Count of Units | lesions | Baseline to 12 month | lesions | lesions |
|
|
|
| 0 |
| 23 |
| 1 |
| 23 |
| 0 |
| 23 |
| EG001 | Fluor Protector S | The ammonium fluoride gel will be applied once on the white spot lesions. Fluor Protector S: Fluor Protector S is applied on white spot lesions. | 0 | 23 | 1 | 23 | 0 | 23 |
|
Not provided
| ICDAS score 3-6 |
|
| Nyvad score 2-3 |
|
| Nyvad score 4-6 |
|
| Nyvad score 7-9 |
|
| "Progression" |
|
| "Progression" |
|
| "Progression" |
|
| "Progression" |
|
| "Progression" |
|
| "Progression" |
|