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Completed

NCT Number: NCT06116825

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

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.

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Key information

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).
  • 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).

Treatment and study plan

1450ppm Fluoride toothpaste

Other

1450ppm Fluoride toothpaste

1000Pppm Fluoride toothpaste

Other

1000Pppm Fluoride toothpaste

Primary outcomes

  1. Plaque Control Record (PCR)

    Time frame: 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 outcomes

  1. Teeth cleaning skill

    Time frame: 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?

  2. Self-efficacy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2023
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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