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To evaluate the remineralizing capability of biosmart S-PRG barrier coat varnish and its employment in clinical practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-smart Light Cured Protective Shield with bioactive S-PRG filler technology (PRG Barrier Coat) | Experimental | Surface reaction-type pre-released glass ionomer (S-PRG) fillers containing dental materials are now commercially available. It was shown that PRG filler is an active ingredient with the ability to release and recharge fluoride ions. In addition, S-PRG fillers release five other active ions, Sr2þ, SiO3 2, Naþ, BO3 3, and Al3þ. S-PRG filler has a modulation effect on acidic conditions, causing the surrounding environment to become weakly alkaline upon contact with water or acidic solutions. This effect was thought to be brought by Sr, B, Na, and F ions released from S-PRG filler. A fluoride-releasing coating material containing S-PRG filler (PRG BarrierCoat®, SHOFU, Japan) was manufactured as a coating material to suppress dentin hypersensitivity and prevent caries on smooth surface areas |
|
| 5% NaF varnish (Proflourid Varnish VOCO America Inc.). | Active Comparator | The gold standard remineralizing agent recommended by the guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre- Reacted Glass ionomer) filler technology (PRG Barrier Coat) by (By SHOFU Inc., Japan). | Drug | Surface reaction-type pre-released glass ionomer (S-PRG) fillers containing dental materials are now commercially available. It was shown that PRG filler is an active ingredient with the ability to release and recharge fluoride ions. In addition, S-PRG fillers release five other active ions, Sr2þ, SiO3 2, Naþ, BO3 3, and Al3þ. S-PRG filler has a modulation effect on acidic conditions, causing the surrounding environment to become weakly alkaline upon contact with water or acidic solutions. This effect was thought to be brought by Sr, B, Na, and F ions released from S-PRG filler. A fluoride-releasing coating material containing S-PRG filler (PRG BarrierCoat®, SHOFU, Japan) was manufactured as a coating material to suppress dentin hypersensitivity and prevent caries on smooth surface areas. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Remineralization efficacy. | Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflecting the amount of demineralization | Baseline, 1 month, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caries lesion activity assessment | Visual- tactile. The Nyvad criteria is a visual-tactile caries classification system designed to detect the activity and severity of caries lesions, the diagnostic criteria reflect the entire continuum of caries, ranging from clinically sound surfaces to non-cavitated and microcavitated caries lesions in enamel to frank cavitation into the dentine | Baseline, 1 month, 3 months |
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Inclusion Criteria:
• Age range between 18 and 40 years.
Exclusion Criteria:
• Severe or active periodontal disease.
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|
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C000612974 | PRG Barrier Coat |
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