Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimally invasive therapy using Self-Assembling Peptide P11-4 (CURODONTTM REPAIR) which enhances remineralization of white spot lesions (WSLs). The study aimed to assess clinically the effect of Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR) versus a 5% fluoride varnish (DURAFLOR) on remineralization of enamel White Spot Lesions in primary teeth.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CURODONTTM REPAIR: + Fluoride varnish (DURAFLOR) | Experimental |
| |
| Fluoride Varnish (DURAFLOR) only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR | Other | The WSL was Acid etched with phosphoric acid gel 35-37% for 20 seconds, the tooth surface was rinsed with water and then dried afterwards application of CURODONTTM REPAIR |
| Measure | Description | Time Frame |
|---|---|---|
| Change in DIAGNOdent readings | The measurements with the DIAGNOdent device that provides numerical values from 0 to 99 | Baseline, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ICDAS II scores | Code 0 Sound tooth surface: Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry. Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow. Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown. Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin. After treatment, the evaluation will be performed as follows. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria Faculty of Dentistry | Alexandria | Egypt |
Not provided
| ID | Term |
|---|---|
| C120870 | Duraflor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluoride varnish (DURAFLOR | Other | A very thin coat of the DURAFLOR varnish was applied by a thin brush which was then allowed to dry for 10 seconds. The varnish hardens on contact with saliva or moisture |
|
| Baseline, 3 months, and 6 months |
| Change in Nyvad scores | Code 0: Sound - Normal enamel Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque Code 2: Active caries (surface discontinuity) Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye. Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black. Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure. | Baseline, 3 months, and 6 months |