An interventional study of Cleaning and No oral cleaning in Candidiasis, Oral, sponsored by Faculty Sao Leopoldo Mandic Campinas. Status unknown at 1 site in Brazil. Open to participants aged Up to 2 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by Faculty Sao Leopoldo Mandic Campinas · Not applicable, Interventional, and Prevention
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.
45 studies on the registry are indexed under Candidiasis, Oral; 6 are open to participants now.
This study's planned enrollment of 276 is above the median of 70 across 31 interventional studies indexed under Candidiasis, Oral.
Browse Candidiasis, Oral studies →Faculty Sao Leopoldo Mandic Campinas is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The oral cavity will be clean with gauze and mineral water three times a day.
Other: Cleaning
The oral cavity will not be cleaned.
Other: No oral cleaning
Gauze and mineral water
Absence of cleaning
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)
Time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Mean of patient's birth weight in the test group as assessed by questionnaire
Time frame: 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
Time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Number of cesarean delivery in the test group as assessed by questionnaire
Time frame: 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
Time frame: 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
Time frame: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
Started May 2017 (actual). Primary completion is estimated for Jul 2020, 38 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Faculty Sao Leopoldo Mandic Campinas