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| Name | Class |
|---|---|
| Universidad Nacional Del Altiplano Puno | UNKNOWN |
| University of Washington | OTHER |
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A clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.
A clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDF/FV | Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Diamine Fluoride/Sodium Fluoride Varnish | Device | Application of dental caries arresting topical medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Activity | Caries Lesion Arrest | 5 months |
| Lesion Activity | Caries Lesion Arrest | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Caries Increment | Caries Increment (d2-4mfs) | 5 months |
| Caries Increment | Caries Increment (d2-4mfs) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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The children will be recruited from five schools (Centro Educativo Inicial) in Puno, Peru
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| Name | Affiliation | Role |
|---|---|---|
| Taina Padilla Caceres, DDS | Universidad Nacional del Altiplano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UGEL Manazo | Puno | Peru | ||||
| UGEL Puno 210001 Las Torres |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12407092 | Background | Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767. | |
| 35027545 | Background | Kiesow A, Menzel M, Lippert F, Tanzer JM, Milgrom P. Dentin tubule occlusion by a 38% silver diamine fluoride gel: an in vitro investigation. BDJ Open. 2022 Jan 13;8(1):1. doi: 10.1038/s41405-022-00095-8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2024 | |
| Reset | Aug 13, 2024 | |
| Release | Sep 11, 2024 | |
| Reset | Nov 14, 2024 | |
| Release | Apr 22, 2026 | |
| Reset | May 13, 2026 | |
| Release | May 21, 2026 | |
| Reset | May 21, 2026 | |
| Release | Jun 1, 2026 | |
| Reset | Jun 2, 2026 | |
| Release | Jun 2, 2026 | |
| Reset | Jun 25, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2024 | Aug 13, 2024 | |||
| Sep 11, 2024 |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| New Caries Lesions | Rate of New Caries Lesions ((d2-4mfs) | 5 months |
| New Caries Lesions | Rate of New Caries Lesions ((d2-4mfs) | 12 months |
| Satisfaction with Color Changes in Teeth | Bothered by Color Changes in the teeth (1-10 scale) | 5 months |
| Puno |
| Peru |
| UGEL Puno Magisterial | Puno | Peru |
| UGEL San Jose | Puno | Peru |
| UGEL Villa del Lago | Puno | Peru |
| 38678451 | Derived | Padilla Caceres TC, Cervantes-Alagon S, Castillo JL, Vera Reyes CM, Rothen M, Mancl LA, Milgrom P. Using sequential applications of a novel silver diamine fluoride gel and sodium fluoride varnish to arrest severe early childhood caries lesions: A clinical trial with single group assignment. J Am Dent Assoc. 2024 Jun;155(6):526-535. doi: 10.1016/j.adaj.2024.02.013. Epub 2024 Apr 25. |
| Nov 14, 2024 |
| Apr 22, 2026 | May 13, 2026 |
| May 21, 2026 | May 21, 2026 |
| Jun 1, 2026 | Jun 2, 2026 |
| Jun 2, 2026 | Jun 25, 2026 |
| Jun 28, 2026 |