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One hundred children with white spot lesions on their teeth were divivided into 5 groups of different remineralizing agents to assess their effect on color change and remineralization
Children having at least one tooth clinically diagnosed by white spot lesion were randomly allocated to five groups.
Group one: No treatment was applied (negative control). Group two: Fluoride gel was applied for 5 minutes (positive control). Group three: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) was applied for 5 minutes.
Group four: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) were applied for 5 minutes.
Group five: Nano hydroxyapatite paste (Apagard primo toothpaste) was be applied for 5 minutes.
All children involved in this study were instructed to brush their teeth under the supervision of the researcher before the application of the studied agent.
Each agent was applied to the labial surfaces of each tooth affected with white spot lesion for 5 minutes after cleaning and drying with a cotton roll using an applicator tip. After each application, children were instructed not to eat or drink for one hour. This application was be repeated in-office after one then after two weeks then after six weeks.
Participants received a sterilized pouch containing a sterile container with one of the pastes according to the study group for home application. The application of the paste was carried out under parental supervision and was asked to apply each of the pastes at home three times a day till the end of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment | No Intervention | Negative control | |
| Fluoride gel | Active Comparator | Positive control |
|
| Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) | Experimental | Intervention |
|
| Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) | Experimental | Intervention |
|
| Nano hydroxyapatite paste (Apagard primo toothpaste) | Experimental | Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casein phosphopeptide-amorphous calcium phosphate | Drug | Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of color change | Color change assessmentof white spot lesions using "Easy-shade" device | before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Remineralization assessment | Remineralization assessment will be done using Laser fluorescence device "DIAGNOdent® (KaVo)". | before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed F Rashed, Researcher | National Research Centre, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Centre | Dokki | Giza Governorate | 12622 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40830200 | Derived | El Mansy MM, Rashed MF, Saleh RS. Effect of remineralization after in office followed by home treatment of white spot lesions in children randomized controlled trial. Sci Rep. 2025 Aug 19;15(1):30448. doi: 10.1038/s41598-025-15829-5. |
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Randomized controlled parallel double blinded study
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Blinding to the child participants and legal guardian of each participating child, inter examiner and statistician. The operator and the child were blinded to the intervention from the beginning till teeth polishing. Blinding cannot be done during application of remineralizing agents because of clear visual differences between these agents.
| Casein phosphopeptide-amorphous calcium phosphate + fluoride | Drug | Intervention |
|
|
| Nano hydroxyapatite paste | Drug | Intervention |
|
|
| Fluoride gel | Drug | Positive control |
|
|
| ID | Term |
|---|---|
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
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