Effect of the Amount of Fluoride Toothpaste on Fluoride Availability in the Oral Fluids in Children
2018年2月27日 更新者：Livia Maria Andaló Tenuta、University of Campinas, Brazil
The aim of the study is to determine the fluoride availability in saliva and dental biofilm after the use of increasing amounts of fluoride toothpaste.
Using a crossover and blind design, 15 children (18-42 months old) had their teeth brushed with increasing amounts of fluoride toothpaste.
Fluoride concentration in saliva and dental biofilm was determined up to 30 min after brushing.
研究概览
详细说明
The aim of the study is to determine the fluoride availability in saliva and dental biofilm after the use of increasing amounts of fluoride toothpaste.
Children from 18 to 42 months from a community daycare participated.
The study had a crossover and blind design.
The amounts of toothpastes tested were: 1.
A pea-size amount (0.3 g) of a non-F toothpaste; 2. 0.025 g of a F toothpaste (1,100 ppm F, as NaF); 3. 0.05 g of the same F toothpaste; 4. 0.1 g of the same F toothpaste; or 5. 0.3 g (pea-size) of the same F toothpaste.
Children were to brush their teeth with the designated amount of toothpaste twice/day from Monday to Friday.
In order to allow biofilm accumulation, caregivers were instructed to brush only the occlusal surfaces of primary molars.
On Friday morning, at least one hour after breakfast, saliva and one biofilm sample from the right or left hemiarch were collected and analyzed for fluoride concentration.
Then, brushing with the respective amount of toothpaste was performed, and saliva was collected 5, 15 and 30 min later.
The biofilm from the other side of the mouth was collected after 30 min.
Fluoride concentration in saliva and biofilm samples was determined with an ion-specific electrode.
研究类型
介入性
注册 (实际的)
15
阶段
- 第四阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1年 至 3年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- All children with an informed consent signed by the parents/guardians
Exclusion Criteria:
- Children with at least on active caries lesion
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Pea-size amount of non-F dentifrice
Non-fluoride dentifrice (0 ppm F); to be used twice/day.
Amount to be used: 0.3 g (pea-size amount)
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
|
实验性的：0.025 g of 1,100 ppm F dentifrice
Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day.
Amount to be used: 0.025 g
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
|
实验性的：0.05 g of 1,100 ppm F dentifrice
Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day.
Amount to be used: 0.05 g
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
|
实验性的：0.1 g of 1,100 ppm F dentifrice
Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day.
Amount to be used: 0.1 g
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
|
有源比较器：Pea-size amount of 1,100 ppm F dentifrice
Fluoride dentifrice (1,100 ppm F, as NaF); to be used twice/day.
Amount to be used: 0.3 g (pea-size amount)
|
Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Fluoride concentration in saliva before brushing
大体时间：Before brushing (baseline)
|
Before brushing (baseline)
|
|
Fluoride concentration in saliva 5 min after brushing
大体时间：5 minutes after brushing
|
5 minutes after brushing
|
|
Fluoride concentration in saliva 15 min after brushing
大体时间：15 min after brushing
|
15 min after brushing
|
|
Fluoride concentration in saliva 30 min after brushing
大体时间：30 min after brushing
|
30 min after brushing
|
|
Fluoride concentration in dental biofilm (fluid fraction) before brushing
大体时间：Before brushing (baseline)
|
Before brushing (baseline)
|
|
Fluoride concentration in dental biofilm (fluid fraction) 30 min after brushing
大体时间：30 min after brushing
|
30 min after brushing
|
|
Fluoride concentration in dental biofilm (solid fraction) before brushing
大体时间：Before brushing (baseline)
|
Before brushing (baseline)
|
|
Fluoride concentration in dental biofilm (solid fraction) 30 min after brushing
大体时间：30 min after brushing
|
30 min after brushing
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年3月1日
初级完成 (实际的)
2010年12月31日
研究完成 (实际的)
2011年6月30日
研究注册日期
首次提交
2018年2月21日
首先提交符合 QC 标准的
2018年2月27日
首次发布 (实际的)
2018年3月6日
研究记录更新
最后更新发布 (实际的)
2018年3月6日
上次提交的符合 QC 标准的更新
2018年2月27日
最后验证
2018年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.