An Early Phase 1 interventional study of 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). in Caries, Dental, Remineralization and White Spot Lesion, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment
To evaluate the remineralizing capability of biosmart S-PRG barrier coat varnish and its employment in clinical practice
1,110 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's planned enrollment of 26 is below the median of 60 across 917 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Age range between 18 and 40 years.
Exclusion Criteria:
Severe or active periodontal disease.
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
Drug: 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).
The gold standard remineralizing agent recommended by the guidelines
Drug: 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).
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.
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
Time frame: Baseline, 1 month, 3 months
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
Time frame: Baseline, 1 month, 3 months
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Cairo University