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Completed

NCT Number: NCT06131294

Efficacy Evaluation of Two Different Fluoride Applications

The goal of this clinical trial is to evaluate the remineralizing or preservative effect of two different fluoride-containing products. The main question aims to answer how the mineral content of the active white spot lesions change after the treatment with those two fluoride applications in a split-mouth design by measuring their mineral content via QLF technology.

Each patient will receive both treatments in a split-mouth design. It is comparison between an experimental fluoride application and Fluoride Protector S.

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Key information

Conditions

White Spot Lesion

Age range

13 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipo University

Istanbul, Esenler, 34230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride Application (Experimental Fluoride Application)

Device

Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.

Fluor Protector S

Device

Fluor Protector S is applied on white spot lesions.

Primary outcomes

  1. Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

    Time frame: 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)

  2. Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

    Time frame: 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)

  3. Measurement of White Spot Lesions by QLF Parameters: WSA

    Time frame: Baseline

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

    • white spot area (WSA)

  4. Measurement of White Spot Lesions by QLF Parameters: Delta Q

    Time frame: 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)

  5. Measurement of White Spot Lesions by QLF Parameters: Delta R

    Time frame: 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)

  6. Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

    Time frame: 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)

  7. Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

    Time frame: 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)

  8. Measurement of White Spot Lesions by QLF Parameters: WSA

    Time frame: 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)

  9. Measurement of White Spot Lesions by QLF Parameters: Delta Q

    Time frame: 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)

  10. Measurement of White Spot Lesions by QLF Parameters: Delta R

    Time frame: 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)

  11. Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

    Time frame: 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)

  12. Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

    Time frame: 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)

  13. Measurement of White Spot Lesions by QLF Parameters: WSA

    Time frame: 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)

  14. Measurement of White Spot Lesions by QLF Parameters: Delta Q

    Time frame: 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)

  15. Measurement of White Spot Lesions by QLF Parameters: Delta R

    Time frame: 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)

  16. Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

    Time frame: 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)

  17. Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

    Time frame: 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)

  18. Measurement of White Spot Lesions by QLF Parameters: WSA

    Time frame: 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)

  19. Measurement of White Spot Lesions by QLF Parameters: Delta Q

    Time frame: 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)

  20. Measurement of White Spot Lesions by QLF Parameters: Delta R

    Time frame: 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)

Secondary outcomes

  1. Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)

    Time frame: Baseline

    Evaluation of the clinical status of the lesions:

    0: Sound tooth surface: No evidence of caries after 5 sec air drying

    • 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
    • Distinct visual change in enamel visible when wet, lesion must be visible when dry
    • Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying
    • Underlying dark shadow from dentin
    • Distinct cavity with visible dentin
    • Extensive (more than half the surface) distinct cavity with visible dentin

  2. Severity and Activity of White Spot Lesions by Nyvad Criteria

    Time frame: Baseline

    Evaluation of the clinical status of the lesions:

    0: Sound

    • Active caries (intact surface)
    • Active caries (surface discontinuity)
    • Active caries (cavity)
    • Inactive caries (intact surface)
    • Inactive caries (surface discontinuity)
    • Inactive caries (cavity)
    • Filling (sound surface)
    • Filling+active caries
    • Filling+inactive caries

  3. Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)

    Time frame: 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

  4. Severity and Activity Transition of White Spot Lesions by Nyvad Criteria

    Time frame: 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

  5. Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)

    Time frame: 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

  6. Severity and Activity Transition of White Spot Lesions by Nyvad Criteria

    Time frame: 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

  7. Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)

    Time frame: 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

  8. Severity and Activity Transition of White Spot Lesions by Nyvad Criteria

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Collaborators

  • Istanbul Medipol University Hospital

Registry information

Official study title

Evaluation of Effectiveness of a Novel Remineralizing Agent: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 14, 2023
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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