HealthyNCT06116825
The Effect of Brushing With Fluoride Toothpaste on Dental Plague Control for Elementary School Students
A study testing 1450ppm Fluoride toothpaste and 1000Pppm Fluoride toothpaste in people with Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 1450ppm Fluoride toothpaste and 1000Pppm Fluoride toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Oct 2022to 27 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Chiayi County has jurisdiction over elementary school students in grades three to six
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- 1450ppm Fluoride toothpaste, 1000Pppm Fluoride toothpaste
- Keywords
- children, Health Education, brushing technique, dental plaque
- Medical subject headings
- Health Education, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1450ppm Fluoride toothpasteOther
1450ppm Fluoride toothpaste
1000Pppm Fluoride toothpasteOther
1000Pppm Fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 1000Pppm Fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline PCR at 6-week after intervention
Secondary outcomes (2)
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?
Measured: 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
Measured: Change from Baseline at 6-week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start20 Oct 2022
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HSIAO-LING HUANG, Dr.PH, Principal investigator, Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116825
- Sponsor's protocol ID
- KMUHIRB-SV(I)-20220008
- Status last verified
- May 2022
- First submitted
- 31 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brushing With Fluoride Toothpaste on Dental Plague Control for Elementary School Students
- ClinicalTrials.gov ID
- NCT06116825
- Acronym / sponsor ID
- KMUHIRB-SV(I)-20220008
- Conditions
- Healthy
- Keywords
- children, Health Education, brushing technique, dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Other: 1450ppm Fluoride toothpasteIn 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. |
| Control group | Active comparator | Other: 1000Pppm Fluoride toothpasteIn 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. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Chiayi County has jurisdiction over elementary school students in grades three to six
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1450ppm Fluoride toothpaste1450ppm Fluoride toothpaste | Other | Experiment group |
| 1000Pppm Fluoride toothpaste1000Pppm Fluoride toothpaste | Other | Control group |
Primary outcome
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.
2 secondary outcomes
Teeth cleaning skill
Time frame: Change from Baseline at 6-week after intervention
Self-efficacy
Time frame: Change from Baseline at 6-week after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HSIAO-LING HUANG, Dr.PH principal investigator
Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1450ppm Fluoride toothpaste and 1000Pppm Fluoride toothpaste in people with Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Control Record (PCR) (time frame: Change from Baseline PCR at 6-week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.