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Efficacy Evaluation of Two Different Fluoride Applications
NA trial testing Fluoride Application (Experimental Fluoride Application) in White Spot Lesion in 23 participants. Completed in 16 April 2024.
| Lead sponsor | Ivoclar Vivadent AG |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 24 February 2023 |
| Primary completion | 31 May 2023 |
| Estimated completion | 16 April 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Ivoclar Vivadent AG — full company profile →
Adults 13 to 50, any sex, with White Spot Lesion. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | -28.2 | ± 10.8 |
| Fluor Protector S | -26.3 | ± 13.2 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | -12.5 | ± 4.0 |
| Fluor Protector S | -12.2 | ± 5.4 |
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- white spot area (WSA)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | 376.0 | ± 404.6 |
| Fluor Protector S | 361.6 | ± 296.7 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | -6539 | ± 8228 |
| Fluor Protector S | -5022 | ± 5181 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | 26.5 | ± 17.9 |
| Fluor Protector S | 27.3 | ± 25.5 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | -26.3 | ± 14.8 |
| Fluor Protector S | -25.6 | ± 12.2 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | -12.2 | ± 5.4 |
| Fluor Protector S | -11.9 | ± 4.7 |
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- white spot area (WSA)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | 446.8 | ± 493.0 |
| Fluor Protector S | 444.3 | ± 334.9 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | -7105 | ± 9351 |
| Fluor Protector S | -6234 | ± 5988 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | 26.4 | ± 22.7 |
| Fluor Protector S | 32.7 | ± 20.2 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | -21.2 | ± 12.0 |
| Fluor Protector S | -26.1 | ± 13.8 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Experimental Fluoride Application | -10.1 | ± 4.9 |
| Fluor Protector S | -12.5 | ± 5.8 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Expermental Fluoride Appli… | Fluor Protector S |
|---|---|---|---|
| osteosarcoma | General disorders | — | — |
Most-reported serious reactions: osteosarcoma.
Data from ClinicalTrials.gov NCT06131294 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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