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the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.
The primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with MI varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and Colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): MI varnish and test group 2 (n=22) :curodont repair fluoride plus. Each material is applied once every 2 weeks for 3 times (intensive mode of application). The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| curodont repair fluoride plus | Experimental | self-assembling peptide (p11-4) with 0.05% sodium fluoride |
|
| CPP-ACPF varnish | Experimental | casein phoshphopeptide amorphous calcium phosphate fluoride (CPP-ACPF ) |
|
| 5 % sodium fluoride varnish | Active Comparator | 5% sodium fluoride varnish |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self assmbling peptide p11-4 combined with 0.05% fluoride | Drug | biomimetic remineralizing agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the remineralization of early carious lesions in primary teeth | comparing the remineralization effect of different remineralizing agents both qualitatively by comparing the change in ICDAS -11 criteria and quantitatively by using laser fluorescence scores using kavo DIAGNOdent classic after intensive mode of application of the different remineralizing agents | 3,6,9 and12 months |
| Measure | Description | Time Frame |
|---|---|---|
| comparing the change in esthetic appearance of early carious lesion before and after treatment | comparing the change in lesion size using standardized photographs quantitatively by calculating pixel size of the lesion before treatment and after 6 and 12 months of intensive mode of application of the different remineralizing agents using ImageJ software program for image analysis. Assessing the esthetic appearance of the lesions will be done subjectively by using a visual analogue scale score from 1 to 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| karin dowidar, professor | faculty of Dentistry, Alexandria university, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karin Dowidar | Alexandria | Professor | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33662244 | Background | Mekky AI, Dowidar KML, Talaat DM. Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish in Remineralization of Early Carious Lesions in Primary Dentition: Randomized Clinical Trial. Pediatr Dent. 2021 Jan 15;43(1):17-23. |
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only the results of the primary and secondary outcomes of the study will be published after study completion
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| Casein phosphopeptide amorphous calcium phosphate | Drug | remineralizing agents that acts as a fluoride booster |
|
|
| 5% sodium fluoride varnish | Drug | remineralizing agent that is used as a gold standard for remineralization |
|
|
| 12 months |
| comparing the antibacterial effect of different remineralizing agents against streptococcus mutans | Supragingival plaque samples will be collected at baseline then after 48 hours, 1 months and 3 months of application of the materials in an intensive mode. log count of streptococcus mutans is determined using disk diffusion method using mitis salivaris agar plates | 3 months |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
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