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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-10-11 | Registry Identifier | COMITATO DI BIOETICA DELLA ASL DI SASSARI |
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| Name | Class |
|---|---|
| World Health Organization | OTHER |
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The hypothesis of this study is that the concentration of fluoride in oral interproximal fluids would increase more after using high-viscosity GIC as pit and fissure sealant, compared to Resin-Based sealants containing fluoride and RB sealants without fluoride content. To validate this hypothesis a randomized clinical trial was designed and performed in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing fluoride and RB sealants without fluoride content.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glass Ionomer Cement group | Experimental | a high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) |
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| Resin Based Fluoride Group | Experimental | white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) |
|
| Resin Based sealant | Placebo Comparator | white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sealant application | Other | A high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) will be used. All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam; tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary. |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-proximal fluid fluoride concentration | Inter-proximal fluid was collected with a paper point in the mesial inter-proximal space of the sealed tooth for 15 seconds. Each sample was prepared for the analysis as follow: added of 0.5 ml TISAB III to reach a pH 5 and shaken with magnetic stirrer thermostated at 25°C for 15 seconds. 100 ml of the solution was then placed on a Petri dish for the analysis. Fluoride concentration was carried out with an Orion model 96.09 fluoride ion selective electrode and an Orion model 900200 double junction plastic body Ag/AgCl reference electrode with an Orion model 290 mV digital meter. | 21 days after application |
| Measure | Description | Time Frame |
|---|---|---|
| caries incidence | measurement of tooth caries at D1, D2 D3 level (both enamel and dentinal caries) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Microsurgery and Medicine Sciences University of Sassari | Sassari | Sardinia | I-07100 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24846910 | Derived | Cagetti MG, Carta G, Cocco F, Sale S, Congiu G, Mura A, Strohmenger L, Lingstrom P, Campus G; Italian Experimental Group on Oral Health. Effect of Fluoridated Sealants on Adjacent Tooth Surfaces: A 30-mo Randomized Clinical Trial. J Dent Res. 2014 Jul;93(7 Suppl):59S-65S. doi: 10.1177/0022034514535808. Epub 2014 May 20. | |
| 23690357 |
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|
| sealant application | Other | A white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) will be used. All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary. |
|
| sealant application | Other | A white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) will be used. All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary. |
|
| WHO CC University of Milan |
| Milan |
| I-20121 |
| Italy |
| Campus G, Carta G, Cagetti MG, Bossu M, Sale S, Cocco F, Conti G, Nardone M, Sanna G, Strohmenger L, Lingstrom P; Italian Experimental Group on Oral Health. Fluoride concentration from dental sealants: a randomized clinical trial. J Dent Res. 2013 Jul;92(7 Suppl):23S-8S. doi: 10.1177/0022034513484329. Epub 2013 May 20. |