Effect of Oral Hygienization in Newborn on Candida Spp Colonization and Child Behavior During Hygiene Habits
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Colonization of Candida spp.
研究概览
简要总结
Oral hygiene is one of the most accessible and well-known strategies for the prevention of dental caries. The benefits of this practice after tooth eruption are well established in the literature. Oral hygiene in newborns prior to tooth eruption is controversial, since there is a disagreement between the Dental and Pediatric Associations as to the optimal time to initiate oral hygiene in children and scientific studies in this regard have not yet been performed. Some of these associations recommend starting this practice from the eruption of the child's first tooth. Others recommend beginning the cleansing of the child's oral cavity from birth by cleaning the baby's gingival rollers and tongue. The aim of the present investigation will be to evaluate, through a randomized clinical trial, the influence of oral hygiene in newborns on Candida spp colonization. and on the child's behavior during oral hygiene after tooth eruption. Will be included in the study, pairs of mothers and babies born in the maternity of the Hospital Nossa Senhora da Saúde, in Diamantina, Minas Gerais, Brazil.
This will be a rehearsal Randomized clinical trial in which newborns will be allocated into 2 groups, namely:
- Newborns whose parents will receive guidelines for oral hygiene before tooth eruption (Group 1);
- Newborns whose parents will receive instructions not to perform oral hygiene before tooth eruption (Group 2).
The initial data collection will be performed one month after the child's birth and will include oral clinical examinations, saliva collection and questionnaires on the socio-environmental, economic and behavioral aspects of the child and his family. Initial oral clinical examinations will be performed to assess the presence of Candidiasis, and saliva collection will be performed to identify and quantification of Candida spp. These evaluations will be performed again every three months. From the eruption of the first deciduous tooth, the follow-up included an assessment of the baby's behavior during oral hygiene performed by the responsible. This evaluation will be made by the examiner using the Frankl scale and HBCD scale criteria. Statistical analysis will be performed using the Statistical Package for Social Science, version 23.0 and will include descriptive, bivariate and multivariate analyzes.
详细描述
Project presentation:
Primary Objective:
To evaluate the influence of oral hygiene of newborns before dental eruption on colonization by Candida spp. and about the baby's behavior during oral hygiene performed by parents after tooth eruption.
Secondary Objective:
To evaluate the influence of oral hygiene of newborns before tooth eruption on Candida spp colonization and occurrence of candidiasis during the follow-up period. To evaluate the influence of oral hygiene of newborns before tooth eruption on the its behavior during oral hygiene performed by parents after tooth eruption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blindness The interventions will always be made by the same researcher and will not participate in the evaluations.
Examiner 1 will be blinded to the group in which the examined children were allocated. Mothers will be advised not to disclose the group in which they were allocated during the evaluations.
入排标准
- 年龄范围
- 1 Day 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns who do not yet have erupted teeth at the time of the first assessment (1 month after birth).
- •Newborns whose mothers agree with their participation and that of their child in the study.
排除标准
- •Newborns who present with systemic impairment at the time of the first evaluation (1 month after birth), such as physical, neurological, respiratory diseases, gastroesophageal reflux disease, among others that may alter the oral microbiota.
结局指标
主要结局
Colonization of Candida spp.
时间窗: Four months after the birth of the child
Four months after the birth of the child, an initial oral clinical examination and saliva collection will be performed to evaluate Candida spp colonization. These two assessments will be performed at the child's own home.
次要结局
- Baby Behavior During Oral Hygiene(Thirteen months after the birth of the child)