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The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curodont Repair® ( monomeric self - assembling peptide P11-4 ) | Experimental | Self assembling peptide P11-4 as Curodont Repair® can remineralize WSLs in a deeper manner than fluoride by guided enamel regeneration by forming a three-dimensional matrix within the subsurface body of an initial carious lesion to which calcium and phosphate ions found in natural saliva can bind and build de novo hydroxyapatite crystals. |
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| Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- ) | Experimental | Tri-calcium phosphate can be hydrolyzed rapidly to form calcium hydroxyapatite (HAp). The processes of hydrolysis and formation of HAp are accelerated by the presence of NaF ions as in case of Clinpro white varnish®. Moreover, the HAp formed by such hydrolysis tends to have a greater uptake of fluoride than conventional HAp. |
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| Voco-profluorid® fluoride varnish (5% sodium fluoride) | Active Comparator | Fluoride varnish is the gold standard for treating WSLs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monomeric self - assembling peptide P11-4 | Drug | Monomeric self - assembling peptide P11-4 ( Curodont Repair ) is a remineralizing agent applied on tooth surface after treating it with 3% sodium hypochlorite for 20 seconds then etching it with 37% phosphoric acid for 20 seconds followed by rinsing then dryness. |
| Measure | Description | Time Frame |
|---|---|---|
| Size of WSL ( white spot lesion ) | Size of WSL measured by scored dental probe | through study completion, an average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of caries | Regression of caries evaluated by International Caries Detection and Assessment System (ICDAS) II | through study completion, an average of 8 months |
| Inactivation of active carious lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yara A Abdellatif, BDS | Contact | 00201007627551 | yaraabdellatif@dentistry.cu.edu.eg | |
| Rasha Hatem, PHD | Contact |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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Double blinded ( participant and statistician )
|
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| Tricalcium phosphate fluoride varnish, 5% F- | Drug | Tricalcium phosphate fluoride varnish, 5% F- ( Clinpro White Varnish ) is a remineralizing agent applied on tooth surface after mixing it with a brush onto the dosage guide. |
|
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| fluoride varnish (5% sodium fluoride) | Drug | fluoride varnish (5% sodium fluoride) ( Voco-profluorid ) is a remineralizing agent applied on tooth surface then area is allowed to become wet (either by gentle rinsing or natural salivary flow) to ensure setting of VOCO Profluorid Varnish. |
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Inactivation of active carious lesions evaluated by Lesion activity assessment (LAA-ICDAS)
| through study completion, an average of 8 months |
| Mineral content of WSL | Mineral content of WSL measured by fluorescence camera VistaCam iX | through study completion, an average of 8 months |
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |