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this study aims to evaluate two different materials used to stop dental caries in children. both materials are available at the market. both materials leave black stain after application. we follow up the patients for 1 year to evaluate which one is more effective in stopping dental caries.
Before application of SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. SDF in both groups will be applied directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDF, ToothMate®, Egypt. | Experimental | Egyptian manufactured SDF, 38% silver diamine fluoride is applied. Before application of toothmate SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. SDF in both groups will be applied directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes. All children will be recalled after 6 and 12 months for follow up |
|
| SDF, Advantage arrest®, USA | Active Comparator | USA manufactured SDF, 38% silver diamine fluoride. Before application of Advantage arrest SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. SDF in both groups will be applied directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes. All children will be recalled after 6 and 12 months for follow up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDF, ToothMate®, Egypt | Other | 38% silver diamine fluoride manufactured in Egypt |
|
| Measure | Description | Time Frame |
|---|---|---|
| o Arrest of caries | Arrest of caries through:
| 12 months |
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Inclusion Criteria:
1. Children who are apparently healthy with primary carious teeth aged from 4-7 years.
2. Uncooperative children. 3. Children with financial barrier in accessing dental care 4. Clinically: absence of any pathology or pain except of sensitivity with eating.
5. Parents and patients accepting the new treatment modality and parents assigned the informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Centre | Cairo | Cairo Governorate | 12572 | Egypt |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| SDF, Advantage Arrest USA | Other | 38% silver diamine fluoride , manufactured in USA |
|