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CompletedNCT06131294Updated Oct 23, 2025Results posted

Efficacy Evaluation of Two Different Fluoride Applications

An interventional study of Fluoride Application (Experimental Fluoride Application) and Fluor Protector S in White Spot Lesion, sponsored by Ivoclar Vivadent AG. Completed at 1 site in Turkey (Türkiye). Open to participants aged 13 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-10-23.

Sponsored by Ivoclar Vivadent AG · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2023, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
13 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • White Spot Lesion

Keywords

  • white spot lesion
03

In context

Lead sponsor

Ivoclar Vivadent AG is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 50 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    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.

    Device: Fluoride Application (Experimental Fluoride Application)

  • Active comparator
    Fluor Protector S

    The ammonium fluoride gel will be applied once on the white spot lesions.

    Device: Fluor 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Results

Posted Apr 20, 2025

Participant flow

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

Participant flow — Overall Study
MilestoneExpermental Fluoride ApplicationFluor Protector S
Started2323
6 month recall2121
Completed2121
Not completed22

Outcome measures

PrimaryMeasurement 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
Reported as:
Mean · percent change (%)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
percent change (%)Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)-28.2 ± 10.8-26.3 ± 13.2
PrimaryMeasurement 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
Reported as:
Mean · percent change (%)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
percent change (%)Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)-12.5 ± 4.0-12.2 ± 5.4
PrimaryMeasurement 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
Reported as:
Mean · WSA in px^2
Measurement of White Spot Lesions by QLF Parameters: WSA
WSA in px^2Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: WSA376.0 ± 404.6361.6 ± 296.7
PrimaryMeasurement 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
Reported as:
Mean · delta Q in %px
Measurement of White Spot Lesions by QLF Parameters: Delta Q
delta Q in %pxExperimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta Q-6539 ± 8228-5022 ± 5181
PrimaryMeasurement 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
Reported as:
Mean · delta R in %
Measurement of White Spot Lesions by QLF Parameters: Delta R
delta R in %Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta R26.5 ± 17.927.3 ± 25.5
PrimaryMeasurement 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
Reported as:
Mean · percent change (%)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
percent change (%)Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)-26.3 ± 14.8-25.6 ± 12.2
PrimaryMeasurement 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
Reported as:
Mean · percent change (%)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
percent change (%)Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)-12.2 ± 5.4-11.9 ± 4.7
PrimaryMeasurement 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
Reported as:
Mean · WSA in px^2
Measurement of White Spot Lesions by QLF Parameters: WSA
WSA in px^2Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: WSA446.8 ± 493.0444.3 ± 334.9
PrimaryMeasurement 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
Reported as:
Mean · delta Q in %px
Measurement of White Spot Lesions by QLF Parameters: Delta Q
delta Q in %pxExperimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta Q-7105 ± 9351-6234 ± 5988
PrimaryMeasurement 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
Reported as:
Mean · delta R in %
Measurement of White Spot Lesions by QLF Parameters: Delta R
delta R in %Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta R26.4 ± 22.732.7 ± 20.2
PrimaryMeasurement 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
Reported as:
Mean · percent change (%)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
percent change (%)Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)-21.2 ± 12.0-26.1 ± 13.8
PrimaryMeasurement 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
Reported as:
Mean · percent change (%)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
percent change (%)Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)-10.1 ± 4.9-12.5 ± 5.8
PrimaryMeasurement 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
Reported as:
Mean · WSA in px^2
Measurement of White Spot Lesions by QLF Parameters: WSA
WSA in px^2Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: WSA238.3 ± 272.5266.6 ± 296.3
PrimaryMeasurement 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
Reported as:
Mean · delta Q in %px
Measurement of White Spot Lesions by QLF Parameters: Delta Q
delta Q in %pxExperimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta Q-2628 ± 3216-4181 ± 5833
PrimaryMeasurement 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
Reported as:
Mean · delta R in %
Measurement of White Spot Lesions by QLF Parameters: Delta R
delta R in %Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta R22.4 ± 17.829.5 ± 23.0
PrimaryMeasurement 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
Reported as:
Mean · percent change (%)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
percent change (%)Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)-22.6 ± 12.5-25.3 ± 15.5
PrimaryMeasurement 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
Reported as:
Mean · percent change (%)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
percent change (%)Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)-10.5 ± 5.0-11.6 ± 5.7
PrimaryMeasurement 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
Reported as:
Mean · WSA in px^2
Measurement of White Spot Lesions by QLF Parameters: WSA
WSA in px^2Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: WSA346.4 ± 400.7373.5 ± 345.6
PrimaryMeasurement 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
Reported as:
Mean · delta Q in %px
Measurement of White Spot Lesions by QLF Parameters: Delta Q
delta Q in %pxExperimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta Q-4819 ± 6078-5692 ± 6400
PrimaryMeasurement 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
Reported as:
Mean · delta R in %
Measurement of White Spot Lesions by QLF Parameters: Delta R
delta R in %Experimental Fluoride ApplicationFluor Protector S
Measurement of White Spot Lesions by QLF Parameters: Delta R20.7 ± 17.027.8 ± 22.3
SecondarySeverity 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
Reported as:
Count of units · lesions
Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
lesionsExperimental Fluoride ApplicationFluor Protector S
ICDAS score 0-100
ICDAS score 22828
ICDAS score 3-600
SecondarySeverity 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
Reported as:
Count of units · lesions
Severity and Activity of White Spot Lesions by Nyvad Criteria
lesionsExperimental Fluoride ApplicationFluor Protector S
Nyvad score 000
Nyvad score 12828
Nyvad score 2-300
Nyvad score 4-600
Nyvad score 7-900
SecondarySeverity 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
Reported as:
Count of units · lesions
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
lesionsExperimental Fluoride ApplicationFluor Protector S
"Regression"30
"Unchanged"2527
"Progression"01
SecondarySeverity 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
Reported as:
Count of units · lesions
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
lesionsExperimental Fluoride ApplicationFluor Protector S
"Regression"30
"Unchanged"2527
"Progression"01
SecondarySeverity 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
Reported as:
Count of units · lesions
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
lesionsExperimental Fluoride ApplicationFluor Protector S
"Regression"144
"Unchanged"1420
"Progression"04
SecondarySeverity 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
Reported as:
Count of units · lesions
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
lesionsExperimental Fluoride ApplicationFluor Protector S
"Regression"2114
"Unchanged"710
"Progression"04
SecondarySeverity 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
Reported as:
Count of units · lesions
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
lesionsExperimental Fluoride ApplicationFluor Protector S
"Regression"147
"Unchanged"1316
"Progression"15
SecondarySeverity 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
Reported as:
Count of units · lesions
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
lesionsExperimental Fluoride ApplicationFluor Protector S
"Regression"2212
"Unchanged"512
"Progression"14

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Expermental Fluoride Application0/23 (0%)1/23 (4.3%)0/23 (0%)
Fluor Protector S0/23 (0%)1/23 (4.3%)0/23 (0%)
Most frequent serious events
Most frequent serious events
EventExpermental Fluoride ApplicationFluor Protector S
osteosarcomaGeneral disorders1/231/23

Baseline characteristics

Age, Customized
Age, Customized(Participants)Expermental Fluoride ApplicationFluor Protector STotal
14-40 years old232346
Sex: Female, Male
Sex: Female, Male(Participants)Expermental Fluoride ApplicationFluor Protector STotal
Female9918
Male141428
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Expermental Fluoride ApplicationFluor Protector STotal
Count of participants——0
08

Study locations

1 site
  • Istanbul Medipo University
    Istanbul, Esenler 34230, Turkey (Türkiye)
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 21, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06131294
Lead sponsor
Ivoclar Vivadent AG
Collaborators
Istanbul Medipol University Hospital
Responsible party
Sponsor
First posted
Nov 14, 2023
Start date
Feb 24, 2023
Primary completion
May 31, 2023
Completion
Apr 16, 2024
Results posted
Apr 20, 2025
Last update
Oct 23, 2025

Study contacts

Burcu Gözetici, Dr.
principal investigator · Istanbul Medipo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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