White Spot Lesion
Conditions
Keywords
white spot lesion
Brief summary
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.
Interventions
DEVICEFluoride 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.
DEVICEFluor Protector S
Fluor Protector S is applied on white spot lesions.
Sponsors
Istanbul Medipol University Hospital
Ivoclar Vivadent AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Split-mouth design: Meaning that each patient receives both treatments, but on different teeth.
Eligibility
Sex/Gender
ALL
Age
13 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* At least two active non-cavitated white spot lesions on buccal surfaces of anterior teeth or premolars (ICDAS code 1 and 2; Nyvad score 1) in two different quadrants. * Age between 13 and 50 years * No untreated caries lesions or periodontal disease * No systematic disease or medication (such as antidepressants, antibiotics etc.) that affects salivary flow rate * Subjects claimed regular brushing at least twice a day * Subjects had to agree to keep the scheduled recall appointments for at least 1 year.
Exclusion criteria
* Inactive non-cavitated lesions (Nyvad Score 4) * Lesions with microcavity, cavitation, chipping or discoloration * Lesions at buccal side of the molars * Lesions adjacent to restoration * Developmental white spot lesions such as enamel hypoplasia * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of White Spot Lesions by QLF Parameters: Delta R | Baseline | 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) |
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | Baseline | 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) |
| Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | Baseline | 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) |
| Measurement of White Spot Lesions by QLF Parameters: WSA | Baseline | Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- white spot area (WSA) |
| Measurement of White Spot Lesions by QLF Parameters: Delta Q | Baseline | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity and Activity of White Spot Lesions by Nyvad Criteria | Baseline | 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 |
| Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Baseline to 1 month | 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 |
| Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Baseline to 1 month | 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 |
| Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Baseline | 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 |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
The recruitment period took place between February 2023 and May 2023 in the Restorative Dentistry Department of Medipol University Clinic
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Expermental Fluoride Application | Fluor Protector S | Total |
|---|---|---|---|
| Age, Customized 14-40 years old | 23 Participants | 23 Participants | 46 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 1 / 23 | 1 / 23 |
Outcome results
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)
Time frame: 6 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | -10.1 percent change (%) | Standard Deviation 4.9 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | -12.5 percent change (%) | Standard Deviation 5.8 |
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | -12.5 percent change (%) | Standard Deviation 4 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | -12.2 percent change (%) | Standard Deviation 5.4 |
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)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | -12.2 percent change (%) | Standard Deviation 5.4 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | -11.9 percent change (%) | Standard Deviation 4.7 |
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)
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | -10.5 percent change (%) | Standard Deviation 5 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta F (Average) | -11.6 percent change (%) | Standard Deviation 5.7 |
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)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | -26.3 percent change (%) | Standard Deviation 14.8 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | -25.6 percent change (%) | Standard Deviation 12.2 |
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)
Time frame: 6 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | -21.2 percent change (%) | Standard Deviation 12 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | -26.1 percent change (%) | Standard Deviation 13.8 |
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | -28.2 percent change (%) | Standard Deviation 10.8 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | -26.3 percent change (%) | Standard Deviation 13.2 |
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)
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | -22.6 percent change (%) | Standard Deviation 12.5 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) | -25.3 percent change (%) | Standard Deviation 15.5 |
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta Q | -6539 delta Q in %px | Standard Deviation 8228 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta Q | -5022 delta Q in %px | Standard Deviation 5181 |
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)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta Q | -7105 delta Q in %px | Standard Deviation 9351 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta Q | -6234 delta Q in %px | Standard Deviation 5988 |
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)
Time frame: 6 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta Q | -2628 delta Q in %px | Standard Deviation 3216 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta Q | -4181 delta Q in %px | Standard Deviation 5833 |
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)
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta Q | -4819 delta Q in %px | Standard Deviation 6078 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta Q | -5692 delta Q in %px | Standard Deviation 6400 |
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)
Time frame: 6 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta R | 22.4 delta R in % | Standard Deviation 17.8 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta R | 29.5 delta R in % | Standard Deviation 23 |
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta R | 26.5 delta R in % | Standard Deviation 17.9 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta R | 27.3 delta R in % | Standard Deviation 25.5 |
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)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta R | 26.4 delta R in % | Standard Deviation 22.7 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta R | 32.7 delta R in % | Standard Deviation 20.2 |
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)
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: Delta R | 20.7 delta R in % | Standard Deviation 17 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: Delta R | 27.8 delta R in % | Standard Deviation 22.3 |
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)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: WSA | 446.8 WSA in px^2 | Standard Deviation 493 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: WSA | 444.3 WSA in px^2 | Standard Deviation 334.9 |
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)
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: WSA | 346.4 WSA in px^2 | Standard Deviation 400.7 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: WSA | 373.5 WSA in px^2 | Standard Deviation 345.6 |
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: WSA | 376.0 WSA in px^2 | Standard Deviation 404.6 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: WSA | 361.6 WSA in px^2 | Standard Deviation 296.7 |
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)
Time frame: 6 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Fluoride Application | Measurement of White Spot Lesions by QLF Parameters: WSA | 238.3 WSA in px^2 | Standard Deviation 272.5 |
| Fluor Protector S | Measurement of White Spot Lesions by QLF Parameters: WSA | 266.6 WSA in px^2 | Standard Deviation 296.3 |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Experimental Fluoride Application | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 1 | 28 lesions |
| Experimental Fluoride Application | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 4-6 | 0 lesions |
| Experimental Fluoride Application | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 2-3 | 0 lesions |
| Experimental Fluoride Application | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 7-9 | 0 lesions |
| Experimental Fluoride Application | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 0 | 0 lesions |
| Fluor Protector S | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 7-9 | 0 lesions |
| Fluor Protector S | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 0 | 0 lesions |
| Fluor Protector S | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 1 | 28 lesions |
| Fluor Protector S | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 2-3 | 0 lesions |
| Fluor Protector S | Severity and Activity of White Spot Lesions by Nyvad Criteria | Nyvad score 4-6 | 0 lesions |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Experimental Fluoride Application | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Regression | 21 lesions |
| Experimental Fluoride Application | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Unchanged | 7 lesions |
| Experimental Fluoride Application | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Progression | 0 lesions |
| Fluor Protector S | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Regression | 14 lesions |
| Fluor Protector S | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Unchanged | 10 lesions |
| Fluor Protector S | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Progression | 4 lesions |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Experimental Fluoride Application | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Progression | 1 lesions |
| Experimental Fluoride Application | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Regression | 22 lesions |
| Experimental Fluoride Application | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Unchanged | 5 lesions |
| Fluor Protector S | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Regression | 12 lesions |
| Fluor Protector S | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Unchanged | 12 lesions |
| Fluor Protector S | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Progression | 4 lesions |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Experimental Fluoride Application | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Regression | 3 lesions |
| Experimental Fluoride Application | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Unchanged | 25 lesions |
| Experimental Fluoride Application | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Progression | 0 lesions |
| Fluor Protector S | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Regression | 0 lesions |
| Fluor Protector S | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Unchanged | 27 lesions |
| Fluor Protector S | Severity and Activity Transition of White Spot Lesions by Nyvad Criteria | Progression | 1 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 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
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Experimental Fluoride Application | Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | ICDAS score 0-1 | 0 lesions |
| Experimental Fluoride Application | Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | ICDAS score 2 | 28 lesions |
| Experimental Fluoride Application | Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | ICDAS score 3-6 | 0 lesions |
| Fluor Protector S | Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | ICDAS score 0-1 | 0 lesions |
| Fluor Protector S | Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | ICDAS score 2 | 28 lesions |
| Fluor Protector S | Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | ICDAS score 3-6 | 0 lesions |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Experimental Fluoride Application | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Regression | 14 lesions |
| Experimental Fluoride Application | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Unchanged | 14 lesions |
| Experimental Fluoride Application | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Progression | 0 lesions |
| Fluor Protector S | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Regression | 4 lesions |
| Fluor Protector S | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Unchanged | 20 lesions |
| Fluor Protector S | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Progression | 4 lesions |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Experimental Fluoride Application | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Regression | 14 lesions |
| Experimental Fluoride Application | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Unchanged | 13 lesions |
| Experimental Fluoride Application | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Progression | 1 lesions |
| Fluor Protector S | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Regression | 7 lesions |
| Fluor Protector S | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Unchanged | 16 lesions |
| Fluor Protector S | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Progression | 5 lesions |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Experimental Fluoride Application | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Regression | 3 lesions |
| Experimental Fluoride Application | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Unchanged | 25 lesions |
| Experimental Fluoride Application | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Progression | 0 lesions |
| Fluor Protector S | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Regression | 0 lesions |
| Fluor Protector S | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Unchanged | 27 lesions |
| Fluor Protector S | Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) | Progression | 1 lesions |