Oral HealthMyBRUSH moduleNCT07125560
Effectiveness MyBRUSH Module in Improving Knowledge, Attitude, and Behaviour on Toothpaste Use and Toothbrushing Among 12-Year-Old Children
A study testing MyBRUSH module and BEGIN program in people with Oral Health and Knowledge, run by Universiti Sains Malaysia at 8 sites in Malaysia.
Trial summary
The goal of this intervention study is to study the effectiveness of the oral health education module (MyBRUSH) in improving the knowledge, attitude, and behaviour on toothpaste use and toothbrushing among 12-year-old children. Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Knowledge, Attitude
- What is being tested?
- MyBRUSH module and BEGIN program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 8 sitesMalaysia
- Study dates
- 5 Mar 2025to 1 Jul 2025
- 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 11 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Malaysian citizen
- Children born in 2013, who would be 12-year-old in 2025
- Children using toothpaste during toothbrushing
Who cannot join
- Children with special educational needs based on the Ministry of Education (MOE) Malaysia definition
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Malaysia8 sites
SJKC Pai Sheng
Kunak, Sabah, 91207
SK Kampung Selamat
Kunak, Sabah, 91207
SK Mostyn
Kunak, Sabah, 91207
SK SKIM Kokos
Kunak, Sabah, 91207
SK Balung
Tawau, Sabah, 91000
SK Bombalai
Tawau, Sabah, 91000
SK Holy Trinity
Tawau, Sabah, 91000
SK Jambatan Putih
Tawau, Sabah, 91000
About this study
Official title: The Effectiveness of Oral Health Education Module (MyBRUSH) in Improving Knowledge, Attitude, and Behaviour on Toothpaste Use and Toothbrushing Among 12-Year-Old Children in Tawau Division, Sabah: A Cluster Randomised Controlled Trial
The goal of this intervention study is to study the effectiveness of the oral health education module (MyBRUSH) in improving the knowledge, attitude, and behaviour on toothpaste use and toothbrushing among 12-year-old children. This study also aims to study the effectiveness of the MyBRUSH module in improving dental plaque among 12-year-old children. The main questions it aims to answer are:
- Does the knowledge, attitude, and behaviour on toothpaste use and toothbrushing of 12-year-old children improve after receiving the MyBRUSH module?
- Does the dental plaque score of 12-year-old children improve after receiving the MyBRUSH module?
- Does the improvement in knowledge, attitude, and behaviour regarding toothpaste use and toothbrushing, as well as the dental plaque of 12-year-old children, be higher after receiving the MyBRUSH module compared to those who received the existing toothbrushing module?
Read more
Researchers will compare the MyBRUSH module to a BEGIN (existing toothbrushing module) to see if the MyBRUSH module is effective in improving the knowledge, attitude, and behaviour on toothpaste use and toothbrushing, as well as the dental plaque of 12-year-old children.
Participants will:
- A questionnaire will be used to assess knowledge, attitude, and behaviour regarding toothpaste use and toothbrushing. This assessment will be done at four time points (baseline, evaluation-1, evaluation-2, and evaluation-3), with a one-month interval between each time point.
- A group of participants will receive intervention based on MyBRUSH module and another group of participants will receive intervention based on BEGIN. Each intervention activity will be done after each evaluation assessment is completed.
- Conditions
- Oral Health, Knowledge, Attitude, Behavior, Dental Plaque
- Being tested
- MyBRUSH module, BEGIN program
- Keywords
- Toothpastes, Toothbrushing, Children, Intervention effectiveness
- Medical subject headings
- Behavior, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyBRUSH moduleBehavioural
oral health education module that comprises of booklet for educational material, oral health talk, toothbrushing demonstration and return demonstration, and small group discussion
BEGIN programBehavioural
BEGIN program that comprise of toothbrushing demonstration and return demonstration
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: MyBRUSH module |
| Control group | Active comparator | Not described Receives: Behavioral: BEGIN program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, attitude, and behavior
Assessment of knowledge, attitude, and behavior on toothpaste use and toothbrushing using a questionnaire
Measured: Point measurement at baseline, evaluation-1, evaluation-2, and evaluation-3 with 1 month interval for each point measurement (total duration 4 months)
Dental plaque score
Dental plaque score based on Silness and Löe plaque index
Measured: Point measurement at baseline, evaluation-1, evaluation-2, and evaluation-3 with 1 month interval for each point measurement (total duration 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start5 Mar 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohd Ritzuan Abdul Multalib, Universiti Sains Malaysia
- Investigators
- Mohd Ritzuan Abdul Multalib, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125560
- Sponsor's protocol ID
- USM/JEPeM/KK/24040379
- Acronym
- MyBRUSH module
- Status last verified
- Nov 2025
- First submitted
- 9 Aug 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Oral Health Education Module (MyBRUSH) in Improving Knowledge, Attitude, and Behaviour on Toothpaste Use and Toothbrushing Among 12-Year-Old Children in Tawau Division, Sabah: A Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07125560
- Acronym / sponsor ID
- MyBRUSH module / USM/JEPeM/KK/24040379
- Conditions
- Oral Health, Knowledge, Attitude, Behavior, Dental Plaque
- Keywords
- Toothpastes, Toothbrushing, Children, Intervention effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 15 Aug 2025 (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 goal of this intervention study is to study the effectiveness of the oral health education module (MyBRUSH) in improving the knowledge, attitude, and behaviour on toothpaste use and toothbrushing among 12-year-old children. This study also aims to study the effectiveness of the MyBRUSH module in improving dental plaque among 12-year-old children. The main questions it aims to answer are:
- Does the knowledge, attitude, and behaviour on toothpaste use and toothbrushing of 12-year-old children improve after receiving the MyBRUSH module?
- Does the dental plaque score of 12-year-old children improve after receiving the MyBRUSH module?
- Does the improvement in knowledge, attitude, and behaviour regarding toothpaste use and toothbrushing, as well as the dental plaque of 12-year-old children, be higher after receiving the MyBRUSH module compared to those who received the existing toothbrushing module?
Researchers will compare the MyBRUSH module to a BEGIN (existing toothbrushing module) to see if the MyBRUSH module is effective in improving the knowledge, attitude, and behaviour on toothpaste use and toothbrushing, as well as the dental plaque of 12-year-old children.
Participants will:
- A questionnaire will be used to assess knowledge, attitude, and behaviour regarding toothpaste use and toothbrushing. This assessment will be done at four time points (baseline, evaluation-1, evaluation-2, and evaluation-3), with a one-month interval between each time point.
- A group of participants will receive intervention based on MyBRUSH module and another group of participants will receive intervention based on BEGIN. Each intervention activity will be done after each evaluation assessment is completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: MyBRUSH module |
| Control group | Active comparator | Behavioral: BEGIN program |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Malaysian citizen
- Children born in 2013, who would be 12-year-old in 2025
- Children using toothpaste during toothbrushing
Key exclusion criteria (1 listed)
- Children with special educational needs based on the Ministry of Education (MOE) Malaysia definition
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 |
|---|---|---|
| MyBRUSH moduleoral health education module that comprises of booklet for educational material, oral health talk, toothbrushing demonstration and return demonstration, and small group discussion | Behavioural | Intervention group |
| BEGIN programBEGIN program that comprise of toothbrushing demonstration and return demonstration | Behavioural | Control group |
Primary outcome
Knowledge, attitude, and behavior
Time frame: Point measurement at baseline, evaluation-1, evaluation-2, and evaluation-3 with 1 month interval for each point measurement (total duration 4 months)
Assessment of knowledge, attitude, and behavior on toothpaste use and toothbrushing using a questionnaire
Dental plaque score
Time frame: Point measurement at baseline, evaluation-1, evaluation-2, and evaluation-3 with 1 month interval for each point measurement (total duration 4 months)
Dental plaque score based on Silness and Löe plaque index
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 28 Nov 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Mohd Ritzuan Abdul Multalib principal investigator
Universiti Sains Malaysia
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyBRUSH module and BEGIN program in people with Oral Health and Knowledge, run by Universiti Sains Malaysia at 8 sites in Malaysia.
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 3 inclusion and 1 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Malaysia. 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?
Knowledge, attitude, and behavior (time frame: Point measurement at baseline, evaluation-1, evaluation-2, and evaluation-3 with 1 month interval for each point measurement (total duration 4 months)). The study lists 2 primary outcomes in all. 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 28 Nov 2025.