Efficacy Evaluation of Two Different Fluoride Applications (LL4470462)

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

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

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

Study Overview

• Status: Completed
• Conditions: White Spot Lesion
• Intervention / Treatment: Device: Fluoride Application (Experimental Fluoride Application); Device: Fluor Protector S

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Esenler
    • Istanbul, Esenler, Turkey (Türkiye), 34230
      • Istanbul Medipo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.
Active Comparator: Fluor Protector S; The ammonium fluoride gel will be applied once on the white spot lesions.	Device: Fluor Protector S; Fluor Protector S is applied on white spot lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)	Baseline
Measurement of White Spot Lesions by QLF Parameters: WSA	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA)	Baseline
Measurement of White Spot Lesions by QLF Parameters: Delta Q	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)	Baseline
Measurement of White Spot Lesions by QLF Parameters: Delta R	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)	Baseline
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)	1 Month
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)	1 Month
Measurement of White Spot Lesions by QLF Parameters: WSA	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA)	1 Month
Measurement of White Spot Lesions by QLF Parameters: Delta Q	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)	1 Month
Measurement of White Spot Lesions by QLF Parameters: Delta R	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)	1 Month
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)	6 Month
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)	6 Month
Measurement of White Spot Lesions by QLF Parameters: WSA	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA)	6 Month
Measurement of White Spot Lesions by QLF Parameters: Delta Q	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)	6 Month
Measurement of White Spot Lesions by QLF Parameters: Delta R	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)	6 Month
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)	12 Month
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)	12 Month
Measurement of White Spot Lesions by QLF Parameters: WSA	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA)	12 Month
Measurement of White Spot Lesions by QLF Parameters: Delta Q	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)	12 Month
Measurement of White Spot Lesions by QLF Parameters: Delta R	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)	12 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; 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	Baseline
Severity and Activity of White Spot Lesions by Nyvad Criteria	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	Baseline
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)	Evaluation of the clinical status of the lesions: "progression" = ICDAS score increased from 2 to 3; "unchanged" = ICDAS score 2; "regression" = ICDAS score decreased from 2 to 0 or 1	Baseline to 1 month
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria	Evaluation of the clinical status of the lesions: "progression" = Nyvad score changed from 1 to 2 or 5; "unchanged" = Nyvad score 1; "regression" = Nyvad score changed from 1 to 0 or 4	Baseline to 1 month
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)	Evaluation of the clinical status of the lesions: "progression" = ICDAS score increased from 2 to 3; "unchanged" = ICDAS score 2; "regression" = ICDAS score decreased from 2 to 0 or 1	Baseline to 6 month
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria	Evaluation of the clinical status of the lesions: "progression" = Nyvad score changed from 1 to 2 or 5; "unchanged" = Nyvad score 1; "regression" = Nyvad score changed from 1 to 0 or 4	Baseline to 6 month
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)	Evaluation of the clinical status of the lesions: "progression" = ICDAS score increased from 2 to 3; "unchanged" = ICDAS score 2; "regression" = ICDAS score decreased from 2 to 0 or 1	Baseline to 12 month
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria	Evaluation of the clinical status of the lesions: "progression" = Nyvad score changed from 1 to 2 or 5; "unchanged" = Nyvad score 1; "regression" = Nyvad score changed from 1 to 0 or 4	Baseline to 12 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Parameters	Occurence of adverse device effects: allergic reactions or irritations on mucosa	Baseline to 1 year

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG
• Collaborators: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Burcu Gözetici, Dr., Istanbul Medipo University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): April 16, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: white spot lesion
• Additional Relevant MeSH Terms: Dentistry; Preventive Dentistry; Fluoridation; Fluoride Treatment
• Other Study ID Numbers: LL4470462

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No