Trial Outcomes & Findings for Efficacy Evaluation of Two Different Fluoride Applications (NCT NCT06131294)

NCT ID: NCT06131294

Last Updated: 2025-10-23

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-10-23

Participant Flow

The recruitment period took place between February 2023 and May 2023 in the Restorative Dentistry Department of Medipol University Clinic

Unit of analysis: Lesions

Participant milestones

Measure	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.	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.
Overall Study STARTED	23 30	23 30
Overall Study 6 month recall	21 28	21 28
Overall Study COMPLETED	21 28	21 28
Overall Study NOT COMPLETED	2 2	2 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Expermental Fluoride Application n=23 Participants 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.	Fluor Protector S n=23 Participants 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.	Total n=46 Participants Total of all reporting groups
Age, Customized 14-40 years old	23 Participants n=23 Participants	23 Participants n=23 Participants	46 Participants n=46 Participants
Sex: Female, Male Female	9 Participants n=23 Participants	9 Participants n=23 Participants	18 Participants n=46 Participants
Sex: Female, Male Male	14 Participants n=23 Participants	14 Participants n=23 Participants	28 Participants n=46 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	-28.2 percent change (%) Standard Deviation 10.8	-26.3 percent change (%) Standard Deviation 13.2

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	-12.5 percent change (%) Standard Deviation 4.0	-12.2 percent change (%) Standard Deviation 5.4

PRIMARY outcome

Timeframe: Baseline

Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:

• white spot area (WSA)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: WSA	376.0 WSA in px^2 Standard Deviation 404.6	361.6 WSA in px^2 Standard Deviation 296.7

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta Q	-6539 delta Q in %px Standard Deviation 8228	-5022 delta Q in %px Standard Deviation 5181

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta R	26.5 delta R in % Standard Deviation 17.9	27.3 delta R in % Standard Deviation 25.5

PRIMARY outcome

Timeframe: 1 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	-26.3 percent change (%) Standard Deviation 14.8	-25.6 percent change (%) Standard Deviation 12.2

PRIMARY outcome

Timeframe: 1 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	-12.2 percent change (%) Standard Deviation 5.4	-11.9 percent change (%) Standard Deviation 4.7

PRIMARY outcome

Timeframe: 1 Month

Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:

• white spot area (WSA)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: WSA	446.8 WSA in px^2 Standard Deviation 493.0	444.3 WSA in px^2 Standard Deviation 334.9

PRIMARY outcome

Timeframe: 1 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta Q	-7105 delta Q in %px Standard Deviation 9351	-6234 delta Q in %px Standard Deviation 5988

PRIMARY outcome

Timeframe: 1 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta R	26.4 delta R in % Standard Deviation 22.7	32.7 delta R in % Standard Deviation 20.2

PRIMARY outcome

Timeframe: 6 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	-21.2 percent change (%) Standard Deviation 12.0	-26.1 percent change (%) Standard Deviation 13.8

PRIMARY outcome

Timeframe: 6 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	-10.1 percent change (%) Standard Deviation 4.9	-12.5 percent change (%) Standard Deviation 5.8

PRIMARY outcome

Timeframe: 6 Month

Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:

• white spot area (WSA)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: WSA	238.3 WSA in px^2 Standard Deviation 272.5	266.6 WSA in px^2 Standard Deviation 296.3

PRIMARY outcome

Timeframe: 6 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta Q	-2628 delta Q in %px Standard Deviation 3216	-4181 delta Q in %px Standard Deviation 5833

PRIMARY outcome

Timeframe: 6 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta R	22.4 delta R in % Standard Deviation 17.8	29.5 delta R in % Standard Deviation 23.0

PRIMARY outcome

Timeframe: 12 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	-22.6 percent change (%) Standard Deviation 12.5	-25.3 percent change (%) Standard Deviation 15.5

PRIMARY outcome

Timeframe: 12 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	-10.5 percent change (%) Standard Deviation 5.0	-11.6 percent change (%) Standard Deviation 5.7

PRIMARY outcome

Timeframe: 12 Month

Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:

• white spot area (WSA)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: WSA	346.4 WSA in px^2 Standard Deviation 400.7	373.5 WSA in px^2 Standard Deviation 345.6

PRIMARY outcome

Timeframe: 12 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta Q	-4819 delta Q in %px Standard Deviation 6078	-5692 delta Q in %px Standard Deviation 6400

PRIMARY outcome

Timeframe: 12 Month

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)

Outcome measures

Measure	Experimental Fluoride Application n=28 Lesions 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.	Fluor Protector S n=28 Lesions 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.
Measurement of White Spot Lesions by QLF Parameters: Delta R	20.7 delta R in % Standard Deviation 17.0	27.8 delta R in % Standard Deviation 22.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Experimental Fluoride Application n=28 lesions 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.	Fluor Protector S n=28 lesions 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.
Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) ICDAS score 0-1	0 lesions	0 lesions
Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) ICDAS score 2	28 lesions	28 lesions
Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes) ICDAS score 3-6	0 lesions	0 lesions

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Experimental Fluoride Application n=28 lesions 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.	Fluor Protector S n=28 lesions 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.
Severity and Activity of White Spot Lesions by Nyvad Criteria Nyvad score 0	0 lesions	0 lesions
Severity and Activity of White Spot Lesions by Nyvad Criteria Nyvad score 2-3	0 lesions	0 lesions
Severity and Activity of White Spot Lesions by Nyvad Criteria Nyvad score 4-6	0 lesions	0 lesions
Severity and Activity of White Spot Lesions by Nyvad Criteria Nyvad score 1	28 lesions	28 lesions
Severity and Activity of White Spot Lesions by Nyvad Criteria Nyvad score 7-9	0 lesions	0 lesions

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Experimental Fluoride Application n=28 lesions 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.	Fluor Protector S n=28 lesions 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.
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) "Progression"	0 lesions	1 lesions
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) "Regression"	3 lesions	0 lesions
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) "Unchanged"	25 lesions	27 lesions

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Experimental Fluoride Application n=28 lesions 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.	Fluor Protector S n=28 lesions 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.
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria "Regression"	3 lesions	0 lesions
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria "Unchanged"	25 lesions	27 lesions
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria "Progression"	0 lesions	1 lesions

SECONDARY outcome

Timeframe: Baseline to 6 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

Outcome measures

Measure	Experimental Fluoride Application n=28 lesions 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.	Fluor Protector S n=28 lesions 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.
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) "Regression"	14 lesions	4 lesions
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) "Unchanged"	14 lesions	20 lesions
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) "Progression"	0 lesions	4 lesions

SECONDARY outcome

Timeframe: Baseline to 6 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

Outcome measures

Measure	Experimental Fluoride Application n=28 lesions 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.	Fluor Protector S n=28 lesions 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.
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria "Progression"	0 lesions	4 lesions
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria "Regression"	21 lesions	14 lesions
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria "Unchanged"	7 lesions	10 lesions

SECONDARY outcome

Timeframe: Baseline to 12 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

Outcome measures

Measure	Experimental Fluoride Application n=28 lesions 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.	Fluor Protector S n=28 lesions 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.
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) "Regression"	14 lesions	7 lesions
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) "Unchanged"	13 lesions	16 lesions
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes) "Progression"	1 lesions	5 lesions

SECONDARY outcome

Timeframe: Baseline to 12 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

Outcome measures

Measure	Experimental Fluoride Application n=28 lesions 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.	Fluor Protector S n=28 lesions 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.
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria "Regression"	22 lesions	12 lesions
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria "Unchanged"	5 lesions	12 lesions
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria "Progression"	1 lesions	4 lesions

Adverse Events

Expermental Fluoride Application

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluor Protector S

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Expermental Fluoride Application n=23 participants at risk 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.	Fluor Protector S n=23 participants at risk 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.
General disorders osteosarcoma	4.3% 1/23 • 1 year	4.3% 1/23 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Team Leader Study Management

Ivoclar Vivadent AG

Phone: +4232353780

Email: patrizia.elkuch-hoch@ivoclar.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60