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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: 1450ppm Fluoride toothpaste; Other: 1000Pppm Fluoride toothpaste

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experiment group; In the experimental group, students from grades three to six in four primary schools in Chiayi County participated. Participating school children are taught the correct method of brushing their teeth, and flossing is also taught in the upper grades. The experimental group used toothpaste containing 1,450 ppm fluoride and asked students to use it at least twice a day, one of which was to clean their teeth before bed. During the pre-test and 4-week post-test, the plaque control index (Plaque Control Record; PCR) was checked and a self-administered questionnaire was filled out.	Other: 1450ppm Fluoride toothpaste; 1450ppm Fluoride toothpaste
Active Comparator: Control group; In the control group, students from grades three to six in four primary schools in Chiayi County participated. All participating children receive instruction on proper tooth brushing techniques, with flossing included in higher grades. Schoolchildren in the control group were given toothpaste containing 1,000 ppm fluoride and were asked to use it at least twice a day, including once to clean their teeth before bed. During the pre-test and 4-week post-test, the plaque control index (Plaque Control Record; PCR) was checked and a self-administered questionnaire was filled out.	Other: 1000Pppm Fluoride toothpaste; 1000Pppm Fluoride toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: HSIAO-LING HUANG, Dr.PH, Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): December 27, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Estimated): November 3, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: children; Health Education; dental plaque; brushing technique
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Yersinia Infections; Plague; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: KMUHIRB-SV(I)-20220008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No