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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT06116825
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-10-20
• Primary Completion: 2022-12-27
• Study Completion: 2022-12-27
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plaque Control Record (PCR)	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.

Secondary Outcome Measures

Name	Time	Method
Self-efficacy	Change from Baseline at 6-week after intervention	Self-efficacy is a questionnaire scale. Total of 2 items ex.I am confident that I can brush my teeth clean
Teeth cleaning skill	Change from Baseline at 6-week after intervention	Teeth cleaning skill is a questionnaire scale. Total of 5 items ex. What method do I usually use to brush my teeth?

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan