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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06116825
Enrollment
400
Registered
2023-11-03
Start date
2022-10-20
Completion date
2022-12-27
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

children, Health Education, brushing technique, dental plaque

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.

Interventions

OTHER1450ppm Fluoride toothpaste

1450ppm Fluoride toothpaste

OTHER1000Pppm Fluoride toothpaste

1000Pppm Fluoride toothpaste

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 13 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Plaque Control Record (PCR)Change from Baseline PCR at 6-week after interventionThe 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

MeasureTime frameDescription
Teeth cleaning skillChange from Baseline at 6-week after interventionTeeth cleaning skill is a questionnaire scale. Total of 5 items ex. What method do I usually use to brush my teeth?
Self-efficacyChange from Baseline at 6-week after interventionSelf-efficacy is a questionnaire scale. Total of 2 items ex.I am confident that I can brush my teeth clean

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026