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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06116825
• Other study ID #: KMUHIRB-SV(I)-20220008
• Status: Completed
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: December 27, 2022

Study information

• Verified date: May 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy
• Plague

Intervention

Other:
• 1450ppm Fluoride toothpaste
1450ppm Fluoride toothpaste
• 1000Pppm Fluoride toothpaste
1000Pppm Fluoride toothpaste

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Control Record (PCR)	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.	Change from Baseline PCR at 6-week after intervention
Secondary	Teeth cleaning skill	Teeth cleaning skill is a questionnaire scale. Total of 5 items ex. What method do I usually use to brush my teeth?	Change from Baseline at 6-week after intervention
Secondary	Self-efficacy	Self-efficacy is a questionnaire scale. Total of 2 items ex.I am confident that I can brush my teeth clean	Change from Baseline at 6-week after intervention