An interventional study of surface pre-reacted glass filler coating material in White Spot Lesions, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a continuous pathological process with loss of tooth minerals, demineralization, which involves the destruction of tooth structure from acids. The first sign of early active demineralization is white spot lesions (WSLs) on the tooth surface, meanwhile, subsurface active mineral decomposition.
Deposition of minerals depends on the equilibrium between demineralization and remineralization which may happen as a natural repair mechanism. The aim of this trial is to comparatively evaluate the efficacy of surface pre-reacted glass filler (S-PRG) Barrier Coat coating material against the Icon resin infiltration in the ability to improve the caries lesion state of the WSLs along 1 year. Laser fluorescence was used to compare the two materials to evaluate the caries progression. PRG Barrier Coat group showed immediate significant improvement in LF scores in demineralization progress and inhibition of caries progression with a significant improved effect. S-PRG Barrier Coat was clinically successful strategy in inhibition of caries and improve remineralization.
Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
surface pre-reacted glass filler coating material used to remineralize WSLs
Combination Product: surface pre-reacted glass filler coating material
micro-invasive resin infiltration technique (Icon) in the ability to improve caries lesion state (LF scores) and making the WSLs
Combination Product: surface pre-reacted glass filler coating material
Permaseal composite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs
Combination Product: surface pre-reacted glass filler coating material
Optiguardcomposite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs
Combination Product: surface pre-reacted glass filler coating material
the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs
Assessments of caries lesion state of WSLs:
Assessing of carious lesions state of WSLs, was performed by using Diagnodent pen to record the progression or regression of caries by time. The assessment of the WSLs demineralization condition took place before intervention (baseline) \[T0\], immediately after intervention \[T1\], 3 months later \[T2\] ,6 months later \[T3\] and 1 year later \[T4\].
Time frame: 1 year
Assessment of color change of WSLs:
The difference in color of the WSLs were performed by Vita Easyshade V at the five distinct times: before intervention (baseline) \[T0\], immediately after intervention \[T1\], 3 months later \[T2\] ,6 months later \[T3\] and 1 year later \[T4\].
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Al-Azhar University