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临床试验/NCT06116825
NCT06116825已完成不适用

The Effect of Brushing With Fluoride Toothpaste on Dental Plague Control for Elementary School Students

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
Plaque Control Record (PCR)

研究概览

简要总结

The purpose of this study is to evaluate the effect of correct tooth cleaning and use of fluoride toothpaste after school lunch and before going to bed on primary school children's plaque reduction and tooth cleaning skills.

详细描述

Taking the school as a unit, the participants are children in grades three to six of elementary schools under the jurisdiction of Chiayi County, with a total expected sample size of 400 people.

Through class teaching, the Shelley method of brushing teeth is taught, and flossing instruction is added to senior grades to improve students' teeth cleaning skills. They also use fluoride toothpaste with a concentration of more than 1000PPM to clean teeth after lunch at school and before going home to go to bed. School children were tested for plaque before and after using fluoride toothpaste, collected plaque control index, filled out a self-administered tooth cleaning skills and self-efficacy questionnaire, and tracked changes in the six weeks after use.

Professional dentists and researchers will go to school to conduct dental plaque testing and fill out the first questionnaire for students. They will also use fluoride toothpaste after lunch at school and before going home to go to bed. Together with correct tooth cleaning methods, at 6 weeks Afterwards, the dental plaque test will be carried out again and the second questionnaire will be filled out. Each filling in of the questionnaire will take about ten minutes.

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
None

入排标准

年龄范围
9 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Chiayi County has jurisdiction over elementary school students in grades three to six

排除标准

  • •Students with disability certificates.
  • •School children with congenital serious oral diseases (such as cleft lip and palate).
  • •Children who are unable to operate the Bates tooth brushing method (such as students who are still unable to complete the operation after being guided by teachers and researchers).

研究组 & 干预措施

Experiment group

Experimental

In the experimental group, students from grades three to six in four primary schools in Chiayi County participated. Participating school children are taught the correct method of brushing their teeth, and flossing is also taught in the upper grades. The experimental group used toothpaste containing 1,450 ppm fluoride and asked students to use it at least twice a day, one of which was to clean their teeth before bed. During the pre-test and 4-week post-test, the plaque control index (Plaque Control Record; PCR) was checked and a self-administered questionnaire was filled out.

干预措施: 1450ppm Fluoride toothpaste (Other)

Control group

Active Comparator

In the control group, students from grades three to six in four primary schools in Chiayi County participated. All participating children receive instruction on proper tooth brushing techniques, with flossing included in higher grades. Schoolchildren in the control group were given toothpaste containing 1,000 ppm fluoride and were asked to use it at least twice a day, including once to clean their teeth before bed. During the pre-test and 4-week post-test, the plaque control index (Plaque Control Record; PCR) was checked and a self-administered questionnaire was filled out.

干预措施: 1000Pppm Fluoride toothpaste (Other)

结局指标

主要结局

Plaque Control Record (PCR)

时间窗: Change from Baseline PCR at 6-week after intervention

The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth. A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial). For each patient, PCR will measured each teeth.

次要结局

  • Self-efficacy(Change from Baseline at 6-week after intervention)
  • Teeth cleaning skill(Change from Baseline at 6-week after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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