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Little is known regarding the effectiveness of neonatal oral hygiene and its relationship to colonization by Candida spp. in edentulous oral cavities. Thus, the objective of this study is to evaluate whether the oral hygiene of edentulous infants favors colonization by Candida spp. Newborns with up to 48 hours of life will randomly allocated to two groups. The mothers will instructed to clean the oral cavity with gauze and mineral water three times a day, in the test group, and not to clean, in the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral cleaning | Experimental | The oral cavity will be clean with gauze and mineral water three times a day. |
|
| No oral cleaning | Active Comparator | The oral cavity will not be cleaned. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cleaning | Other | Gauze and mineral water |
| |
| No oral cleaning |
| Measure | Description | Time Frame |
|---|---|---|
| Change from number of Candida spp CFU/mm3 | Non-stimulated saliva will be collected with the aid of a sterile swab (Absorve®) from all infants. The samples were incubated at 37°C and analyzed after 48 hours to quantify the colony forming units (CFU/mm3) | At baseline as well as once a month until the eruption of the first tooth (up to 14 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of patient's birth weight in the test group as assessed by questionnaire | At baseline as well as once a month until the eruption of the first tooth (up to 14 months) | |
| Number of males in the test group as assessed by questionnaire | At baseline as well as once a month until the eruption of the first tooth (up to 14 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Regina E. da Silva, PhD | Contact | +55 11 945179999 | secheverria@uol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Jose Carlos P Imparato, PhD | Faculdade Sao Leopoldo Mandic, Campinas, SP, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Sao Leopoldo Mandic | Recruiting | Campinas | São Paulo | 13045755 | Brazil |
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| ID | Term |
|---|---|
| D002180 | Candidiasis, Oral |
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Other |
Absence of cleaning |
|
| Number of cesarean delivery in the test group as assessed by questionnaire | At baseline as well as once a month until the eruption of the first tooth (up to 14 months) |
| Mean of patient's gestational week in the test group as assessed by questionnaire | At baseline as well as once a month until the eruption of the first tooth (up to 14 months) |
| Mean of patient's birth length in the test group as assessed by questionnaire | At baseline as well as once a month until the eruption of the first tooth (up to 14 months) |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |