Clinical trial NCT06116825: The Effect of Brushing With Fluoride Toothpaste on Dental Plague Control for Elementary School Students
Official title: The Effect of Brushing With Fluoride Toothpaste on Dental Plague Control for Elementary School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: children
Health Education
brushing technique
dental plaque
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 400
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Plaque Control Record (PCR)
timeFrame: Change from Baseline PCR at 6-week after intervention
Secondary outcomes:
measure: Teeth cleaning skill
timeFrame: Change from Baseline at 6-week after intervention
measure: Self-efficacy
timeFrame: Change from Baseline at 6-week after intervention
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
name: HSIAO-LING HUANG, Dr.PH
role: PRINCIPAL_INVESTIGATOR
References: