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

Kaohsiung Medical University

Status: Completed

Conditions: Healthy

Treatments: Other: 1450ppm Fluoride toothpaste; Other: 1000Pppm Fluoride toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT06116825

KMUHIRB-SV(I)-20220008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 patients

Sex: All

Ages: 9 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 1. Students with disability certificates. 2. School children with congenital serious oral diseases (such as cleft lip and palate).

3. 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Experiment group

Experimental group

Description:

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.

Treatment:

Other: 1450ppm Fluoride toothpaste

Control group

Active Comparator group

Description:

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.

Treatment:

Other: 1000Pppm Fluoride toothpaste