Relationship Between Oral Hygiene in Newborns and Candida Spp.: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Change from number of Candida spp CFU/mm3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- — 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A signed statement of informed consent
- •Newborns up to 48 hours of life
- •Exclusive breastfeeding
- •Edentulous oral cavity
排除标准
- •Any feeding other than breastfeeding
- •Use of pacifier
- •Digit sucking
- •Systemic alterations
研究组 & 干预措施
Oral cleaning
The oral cavity will be clean with gauze and mineral water three times a day.
干预措施: Cleaning (Other)
No oral cleaning
The oral cavity will not be cleaned.
干预措施: No oral cleaning (Other)
结局指标
主要结局
Change from number of Candida spp CFU/mm3
时间窗: At baseline as well as once a month until the eruption of the first tooth (up to 14 months)
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)
次要结局
- 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))
- 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 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))
- 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))
研究者
Jose Carlos P Imparato
PhD, Senior Lecturer, Clinical Professor
Faculty Sao Leopoldo Mandic Campinas