White Spot LesionNCT06131294
Efficacy Evaluation of Two Different Fluoride Applications
A study testing Fluoride Application (Experimental Fluoride Application) and Fluor Protector S in people with White Spot Lesion, run by Ivoclar Vivadent AG at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Fluoride Application (Experimental Fluoride Application) and Fluor Protector S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2023to 16 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipo University
Istanbul, Esenler, 34230
About this study
Official title: 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.
- Conditions
- White Spot Lesion
- Being tested
- Fluoride Application (Experimental Fluoride Application), Fluor Protector S
- Keywords
- white spot lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 SDevice
Fluor Protector S is applied on white spot lesions.
| Study group | Role | What they receive |
|---|---|---|
| Expermental Fluoride Application | Experimental | 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. Receives: Device: Fluoride Application (Experimental Fluoride Application) |
| Fluor Protector S | Active comparator | The ammonium fluoride gel will be applied once on the white spot lesions. Receives: Device: Fluor Protector S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 Month
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start24 Feb 2023
- Primary completion31 May 2023
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth design: Meaning that each patient receives both treatments, but on different teeth.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Istanbul Medipol University Hospital
- Responsible party
- Sponsor
- Investigators
- Burcu Gözetici, Dr., Principal investigator, Istanbul Medipo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131294
- Sponsor's protocol ID
- LL4470462
- Status last verified
- Mar 2025
- First submitted
- 2 Nov 2023
- Last updated
- 23 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of a Novel Remineralizing Agent: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06131294
- Acronym / sponsor ID
- LL4470462
- Conditions
- White Spot Lesion
- Keywords
- white spot lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Collaborators
- Istanbul Medipol University Hospital
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design: Meaning that each patient receives both treatments, but on different teeth.
| Arm | Type | Receives |
|---|---|---|
| Expermental Fluoride Application | Experimental | Device: Fluoride Application (Experimental 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. |
| Fluor Protector S | Active comparator | Device: Fluor Protector SThe ammonium fluoride gel will be applied once on the white spot lesions. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Expermental Fluoride Application |
| Fluor Protector SFluor Protector S is applied on white spot lesions. | Device | Fluor Protector S |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
8 secondary outcomes
Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
Time frame: Baseline
Severity and Activity of White Spot Lesions by Nyvad Criteria
Time frame: Baseline
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
Time frame: Baseline to 1 month
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
Time frame: Baseline to 1 month
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
Time frame: Baseline to 6 month
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
Time frame: Baseline to 6 month
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
Time frame: Baseline to 12 month
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
Time frame: Baseline to 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu Gözetici, Dr. principal investigator
Istanbul Medipo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride Application (Experimental Fluoride Application) and Fluor Protector S in people with White Spot Lesion, run by Ivoclar Vivadent AG at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.