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| ID | Type | Description | Link |
|---|---|---|---|
| 2009.1.1081.58.6 | Other Identifier | Institutional Review Board (FORP-USP) | |
| 2009/53788-9 | Other Grant/Funding Number | FAPESP (São Paulo Research Foundation) |
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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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The purpose of this study is to assess if a propolis solution is able to remove plaque and kill microbes from complete dentures. The investigators will compare the results of the propolis-based denture cleanser with those obtained with an inactive solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propolis solution | Experimental | A proprietary denture cleanser with propolis as the active agent. |
|
| Saline solultion | Placebo Comparator | Physiologic saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denture soaking solution | Drug | Immersion of complete dentures in 200ml of a denture soaking solution for 20 minutes. Propolis solution: Spa Dent (Nissin Dental Products Inc., Kyoto, Japan). |
| Measure | Description | Time Frame |
|---|---|---|
| Denture plaque coverage area (%) | Relation between stained area and total surface area on the internal surface of maxillary complete dentures. | At the same day of the intervention, up to 1 hour following denture soaking |
| Measure | Description | Time Frame |
|---|---|---|
| mutans streptococci counts (CFU) | Microbial counts on maxilary denture base, as assessed by a conventional microbiological method. | At the same day of the intervention, up to 1 hour following denture soaking |
| Candida spp. counts (CFU) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphael F de Souza, DDS, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ribeirão Preto Dental School | Ribeirão Preto | São Paulo | 14040-904 | Brazil |
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| Label | URL |
|---|---|
| Institutional page of the Ribeirão Preto Dental School (research site) | View source |
| Principal Investigator´s CV | View source |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D013282 | Stomatitis, Denture |
| D002180 | Candidiasis, Oral |
| C536972 | Torulopsis |
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D013280 | Stomatitis |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Saline solution | Drug | Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes. |
|
Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
| At the same day of the intervention, up to 1 hour following denture soaking |
| D009059 |
| Mouth Diseases |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |