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| Name | Class |
|---|---|
| Iuliu Hatieganu University of Medicine and Pharmacy | OTHER |
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The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Patients are included upon meeting the inclusion criteria as defined for this clinical trial. In the test group, a remineralization of the incipient carious lesion is expected. The patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Fluoride Application | Experimental | Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application) |
|
| Control Group | No Intervention | No Treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Fluoride Application | Device | The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| White Spot Measurement | Analysis of incipient caries or demineralized enamel by using laser fluorescence technology. | Baseline to 1 Year |
| 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
| Baseline to 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ada Delean, Prof. Dr. | Iuliu Hatieganu University of Medicine and Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iuliu Hatieganu, University of Medicine and Pharmacy | Cluj-Napoca | 400012 | Romania |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Fluoride Application | Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application) Experimental Fluoride Application: The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions |
| FG001 | Control Group | No Treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Fluoride Application | Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application) Experimental Fluoride Application: The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | White Spot Measurement | Analysis of incipient caries or demineralized enamel by using laser fluorescence technology. | Posted | Number | Lesions | Baseline to 1 Year | Lesions | Lesions |
|
1 Year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Fluoride Application | Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application) Experimental Fluoride Application: The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Department Study Management | Ivoclar Vivadent AG | +4232353780 | patrizia.elkuch-hoch@ivoclar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2023 | Mar 6, 2026 | Prot_SAP_000.pdf |
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| Control Group |
No Treatment |
| BG002 | Total | Total of all reporting groups |
| Lesions |
|
| participants |
| Participants |
|
|
| Sex/Gender, Customized | Number | participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Lesions |
|
|
| Primary | 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
| Posted | Number | Lesions | Baseline to 1 Year | Lesions | Lesions |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Control Group | No Treatment | 0 | 43 | 0 | 43 | 0 | 43 |
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| Title | Measurements |
|---|---|
|