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Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant that has been on the market for years in children
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helioseal F | Active Comparator | fissure sealing with the conventional product |
|
| Helioseal F Plus | Experimental | fissure sealing with the new product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fissure sealing | Device | sealing of occlusal fissures with either the conventional sealant, Helioseal F, or the new sealant, Helioseal F Plus, which provides an additional feature and an improved formulation |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of the Sealant | grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left | 7-28 days |
| Retention of Sealant | grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left | 12 months |
| Retention of Sealant | grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left | 24 months |
| Retention of Sealant | grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Caries | evaluation of the presence of carious lesions according to UniViSS 2.0 | 7-28 days |
| Caries | evaluation of the presence of carious lesions according to UniViSS 2.0 |
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Inclusion Criteria:
participants
teeth:
Exclusion Criteria:
participants
teeth:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Jan Kühnisch | München | Bavaria | 80336 | Germany | ||
| Zahnarztpraxis Graeser |
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The recruitment phase took place at both study sites from September 2018 to March 2019.
| ID | Title | Description |
|---|---|---|
| FG000 | Helioseal F | fissure sealing with the conventional product fissure sealing: sealing of occlusal fissures with either the conventional sealant, Helioseal F, or the new sealant, Helioseal F Plus, which provides an additional feature and an improved formulation |
| FG001 | Helioseal F Plus | fissure sealing with the new product fissure sealing: sealing of occlusal fissures with either the conventional sealant, Helioseal F, or the new sealant, Helioseal F Plus, which provides an additional feature and an improved formulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Split-Mouth Design: Every patient receives both treatments.
| ID | Title | Description |
|---|---|---|
| BG000 | Helioseal F | fissure sealing with the conventional product fissure sealing: sealing of occlusal fissures with either the conventional sealant, Helioseal F, or the new sealant, Helioseal F Plus, which provides an additional feature and an improved formulation |
| BG001 | Helioseal F Plus |
| 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 | Retention of the Sealant | grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left | Posted | Number | Sealants | 7-28 days | Sealants | Sealants |
|
36 months
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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 | Helioseal F | fissure sealing with the conventional product fissure sealing: sealing of occlusal fissures with either the conventional sealant, Helioseal F, or the new sealant, Helioseal F Plus, which provides an additional feature and an improved formulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Team Leader 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 | Sep 1, 2021 | Mar 26, 2024 | Prot_SAP_000.pdf |
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| 12 months |
| Caries | evaluation of the presence of carious lesions according to UniViSS 2.0 | 24 months |
| Caries | evaluation of the presence of carious lesions according to UniViSS 2.0 | 36 months |
| Wädenswil |
| Canton of Zurich |
| 8820 |
| Switzerland |
fissure sealing with the new product fissure sealing: sealing of occlusal fissures with either the conventional sealant, Helioseal F, or the new sealant, Helioseal F Plus, which provides an additional feature and an improved formulation |
| BG002 | Total | Total of all reporting groups |
| Sealants |
|
| 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 |
|
|
| Region of Enrollment | Herein, the participants | Number | participants | Participants |
|
|
|
|
| Primary | Retention of Sealant | grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left | One Sealant of Helioseal F could not be examined due to an orthodontic bite device. | Posted | Number | Sealants | 12 months | Sealants | Sealants |
|
|
|
| Primary | Retention of Sealant | grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left | One Sealant of Helioseal F could not be examined due to an orthodontic bite device. | Posted | Number | Sealants | 24 months | Sealants | Sealants |
|
|
|
| Primary | Retention of Sealant | grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left | Posted | Number | Sealants | 36 months | Sealants | Sealants |
|
|
|
| Secondary | Caries | evaluation of the presence of carious lesions according to UniViSS 2.0 | Posted | Number | Sealants | 7-28 days | Sealants | Sealants |
|
|
|
| Secondary | Caries | evaluation of the presence of carious lesions according to UniViSS 2.0 | One Sealant of Helioseal F could not be examined due to an orthodontic bite device. | Posted | Number | Sealants | 12 months | Sealants | Sealants |
|
|
|
| Secondary | Caries | evaluation of the presence of carious lesions according to UniViSS 2.0 | One Sealant of Helioseal F could not be examined due to an orthodontic bite device. | Posted | Number | Sealants | 24 months | Sealants | Sealants |
|
|
|
| Secondary | Caries | evaluation of the presence of carious lesions according to UniViSS 2.0 | Posted | Number | Sealants | 36 months | Sealants | Sealants |
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | Helioseal F Plus | fissure sealing with the new product fissure sealing: sealing of occlusal fissures with either the conventional sealant, Helioseal F, or the new sealant, Helioseal F Plus, which provides an additional feature and an improved formulation | 0 | 92 | 0 | 92 | 0 | 92 |
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 2 minimal loss of sealant (max one third) |
|
| 3: central retention of the sealant |
|
| 4: almost complete loss of the sealant - less than one third is left |
|
| 2 minimal loss of sealant (max one third) |
|
| 3: central retention of the sealant |
|
| 4: almost complete loss of the sealant - less than one third is left |
|
| 2 minimal loss of sealant (max one third) |
|
| 3: central retention of the sealant |
|
| 4: almost complete loss of the sealant - less than one third is left |
|
| Cavitated caries |
|
| Cavitated caries |
|
| Cavitated caries |
|
| Cavitated caries |
|