NCT06116825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
Last Updated

November 3, 2023

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

Healthy

Keywords

childrenHealth Educationbrushing techniquedental plaque

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Teeth cleaning skill

    Change from Baseline at 6-week after intervention

  • Self-efficacy

    Change from Baseline at 6-week after intervention

Study Arms (2)

Experiment group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

1450ppm Fluoride toothpasteOTHER

1450ppm Fluoride toothpaste

Experiment group
1000Pppm Fluoride toothpasteOTHER

1000Pppm Fluoride toothpaste

Control group

Eligibility Criteria

Age9 Years - 13 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Chiayi County has jurisdiction over elementary school students in grades three to six

You may not qualify if:

  • \- 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Health EducationDental Plaque

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorDental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • HSIAO-LING HUANG, Dr.PH

    Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 3, 2023

Study Start

October 20, 2022

Primary Completion

December 27, 2022

Study Completion

December 27, 2022

Last Updated

November 3, 2023

Record last verified: 2022-05

Locations

TW(1)