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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.
Fluor Protector S is applied on white spot lesions.
Istanbul Medipo University
Istanbul, Esenler, Turkey (Türkiye)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
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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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 Month
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 1. First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry 3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying 4. Underlying dark shadow from dentin 5. Distinct cavity with visible dentin 6. Extensive (more than half the surface) distinct cavity with visible dentin
Time frame: Baseline
Severity and Activity of White Spot Lesions by Nyvad Criteria
Evaluation of the clinical status of the lesions: 0: Sound 1. Active caries (intact surface) 2. Active caries (surface discontinuity) 3. Active caries (cavity) 4. Inactive caries (intact surface) 5. Inactive caries (surface discontinuity) 6. Inactive caries (cavity) 7. Filling (sound surface) 8. Filling+active caries 9. Filling+inactive caries
Time frame: Baseline
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
Evaluation of the clinical status of the lesions: * "progression" = ICDAS score increased from 2 to 3 * "unchanged" = ICDAS score 2 * "regression" = ICDAS score decreased from 2 to 0 or 1
Time frame: Baseline to 1 month
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
Evaluation of the clinical status of the lesions: * "progression" = Nyvad score changed from 1 to 2 or 5 * "unchanged" = Nyvad score 1 * "regression" = Nyvad score changed from 1 to 0 or 4
Time frame: 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: * "progression" = ICDAS score increased from 2 to 3 * "unchanged" = ICDAS score 2 * "regression" = ICDAS score decreased from 2 to 0 or 1
Time frame: Baseline to 6 month
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
Evaluation of the clinical status of the lesions: * "progression" = Nyvad score changed from 1 to 2 or 5 * "unchanged" = Nyvad score 1 * "regression" = Nyvad score changed from 1 to 0 or 4
Time frame: 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: * "progression" = ICDAS score increased from 2 to 3 * "unchanged" = ICDAS score 2 * "regression" = ICDAS score decreased from 2 to 0 or 1
Time frame: Baseline to 12 month
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
Evaluation of the clinical status of the lesions: * "progression" = Nyvad score changed from 1 to 2 or 5 * "unchanged" = Nyvad score 1 * "regression" = Nyvad score changed from 1 to 0 or 4
Time frame: Baseline to 12 month