OralNCT07115433
Effectiveness of School-based Oral Health Intervention for Children
A study testing School-Based Oral Health Promotion Program in people with Oral and Health, run by Universiti Putra Malaysia at 3 sites in Pakistan.
Trial summary
Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- What is being tested?
- School-Based Oral Health Promotion 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
- 600 participants
- Where
- 3 sitesPakistan
- Study dates
- 5 Aug 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-8 years enrolled in selected schools
- Written informed consent from parents/guardians and assent from children
Who cannot join
- Children with systemic conditions affecting oral health
- Those currently in other oral health interventions
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan3 sites
Saleem ullah fahmi school baqai Medical complex gharo
Karachi, Sindh, 74600
Samreen Z Instructor, BDS, 03150228348, kiranmehwish47@gmail.com
Muhammad Raashed, DVM, 03337474991, muhammad.raashed.eph@gmail.com
Saleem ullah fahmi memorial school unit 1
Karachi, 74600
Mehwish banu, BDS, 03323404875, drmahwishsyed@baqai.edu.pk
Muhammad Arshed, MBBS, PhD, 03337474464, drarshedchaudhary@gmail.com
Saleem ullah fahmi school Khuda ki basti
Karachi, 74600
Samreen Instructor, BDS, +92 332 2536389, drsamreen.shafqat@gmail.com
Muhammad Arshed, MBBS, PhD, 03337474464, drarshedchaudhary@gmail.com
About this study
Official title: Effectiveness of a School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children: A Randomized Controlled Trial
Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes.
A School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children for six months, while the control group will receive no intervention, only routine care.
Read the detailed description
Poor oral health in children leads to pain, absenteeism, and impaired quality of life. Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes.
A School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School. The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months, while the control group will receive no intervention, only routine care.
- Being tested
- School-Based Oral Health Promotion Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-Based Oral Health Promotion ProgramBehavioural
Arm Description: The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over a period of six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will be given no intervention other than they will receive routinely |
| Intervention group | Experimental | Arm Description: The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over a period of six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months. Receives: Behavioral: School-Based Oral Health Promotion Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque score
Plaque score index: 0: No plaque.
- Separate flecks of plaque at the gum line.
- A thin band of plaque along the gum line.
- A band of plaque wider than 1mm but covering less than one-third of the tooth.
- Plaque covering one-third to two-thirds of the tooth.
- Plaque covering more than two-thirds of the tooth. Higher scores indicate more plaque and poorer oral hygiene.
Measured: 6 months
Oral Hygiene
Oral Hygiene will be assessed by the presence of debris (plaque) and calculus (tartar) on selected tooth surfaces, measured by the Simplified Oral Hygiene Index (OHI-S)
Individual Debris Index (DI-S) and Calculus Index (CI-S):
Each of the six surfaces is scored individually for both debris and calculus using a 0-3 scale:
0: No debris or calculus is present.
- Debris or calculus covers less than one-third of the surface.
- Debris or calculus covers between one-third and two-thirds of the surface.
- Debris or calculus covers more than two-thirds of the surface. Good: 0.0 - 1.2 Fair: 1.3 - 3.0 Poor: 3.1 - 6.0
Measured: 6-months
Gingival score
Gingival score assessed by the gingival score index:
0: Normal gingiva, no inflammation.
- Mild inflammation - slight color change and edema (swelling), no bleeding on probing.
- Moderate inflammation - redness, edema, glazing, and bleeding on probing.
- Severe inflammation - marked redness, edema, ulceration, and tendency towards spontaneous bleeding. The index typically uses a scale of 0 to 3, with 0 representing normal gingiva and higher scores indicating increasing severity of inflammation
Measured: 6 months
Secondary outcomes (2)
oral health practices
Oral health practices by using the WHO Child Oral Health Questionnaire: o assess children's oral health practices through a structured set of questions. These questionnaires typically cover knowledge, attitude, and practices related to oral hygiene, including frequency of brushing, use of fluoride toothpaste, and dental visits. The score is used to evaluate the overall oral health practices of the child, often categorized as good, fair, or poor.
Measured: 6 months
Oral Health Impact Profile.
Oral Health Impact Profile. The Oral Health Impact Profile (OHIP) is a questionnaire used to assess how oral health problems affect a person's daily life and well-being. The OHIP-14, a shorter version, is commonly used and focuses on 14 specific questions related to oral health impacts 0 = Never
- = Hardly ever
- = Occasionally
- = Fairly often
- = Very often Greater score shows better impact andvice versa
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start5 Aug 2025 (estimated)
- Primary completion5 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OralStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is two arm randomized control trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115433
- Sponsor's protocol ID
- BMU-BDC
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the study protocol, statistical plan, and results will be shared in publications in peer-reviewed journals
Publications
nsari Moghaddam S, Shahrzad S, Kermansaravi F. Effect of teach-back method on oral health indicators, self-efficacy, and self-care behaviors of high school students in Zahedan during 2019. J Mashhad Dent School. 2020;44(2):99-113.
Hashemi ZS, Khorsandi M, Shamsi M, Moradzadeh R. Effect combined learning on oral health self-efficacy and self-care behaviors of students: a randomized controlled trial. BMC Oral Health. 2021 Jul 13;21(1):342. doi: 10.1186/s12903-021-01693-y.
PubMed 34256752Sanaeinasab H, Saffari M, Taghavi H, Karimi Zarchi A, Rahmati F, Al Zaben F, Koenig HG. An educational intervention using the health belief model for improvement of oral health behavior in grade-schoolers: a randomized controlled trial. BMC Oral Health. 2022 Mar 27;22(1):94. doi: 10.1186/s12903-022-02132-2.
PubMed 35346148Hernandez-Vasquez A, Azanedo D. The urgency of ensuring equitable and improved access to oral health care during the Coronavirus Disease 2019 pandemic: The case of Peru. J Res Health Sci. 2021 Aug 28;21(3):e00528. doi: 10.34172/jrhs.2021.60.
PubMed 34698662
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07115433
- Acronym / sponsor ID
- BMU-BDC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 5 Aug 2025 (estimated)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 11 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.
Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes.
A School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children for six months, while the control group will receive no intervention, only routine care.
Detailed description
Poor oral health in children leads to pain, absenteeism, and impaired quality of life. Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes.
A School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School. The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months, while the control group will receive no intervention, only routine care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It is two arm randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will be given no intervention other than they will receive routinely |
| Intervention group | Experimental | Behavioral: School-Based Oral Health Promotion ProgramArm Description: The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over a period of six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6-8 years enrolled in selected schools
- Written informed consent from parents/guardians and assent from children
Key exclusion criteria (2 listed)
- Children with systemic conditions affecting oral health
- Those currently in other oral health interventions
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 |
|---|---|---|
| School-Based Oral Health Promotion ProgramArm Description: The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over a period of six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months. | Behavioural | Intervention group |
Primary outcome
Plaque score
Time frame: 6 months
Plaque score index: 0: No plaque. 1. Separate flecks of plaque at the gum line. 2. A thin band of plaque along the gum line. 3. A band of plaque wider than 1mm but covering less than one-third of the tooth. 4. Plaque covering one-third to two-thirds of the tooth. 5. Plaque covering more than two-thirds of the tooth. Higher scores indicate more plaque and poorer oral hygiene.
Oral Hygiene
Time frame: 6-months
Oral Hygiene will be assessed by the presence of debris (plaque) and calculus (tartar) on selected tooth surfaces, measured by the Simplified Oral Hygiene Index (OHI-S) Individual Debris Index (DI-S) and Calculus Index (CI-S): Each of the six surfaces is scored individually for both debris and calculus using a 0-3 scale: 0: No debris or calculus is present. 1. Debris or calculus covers less than one-third of the surface. 2. Debris or calculus covers between one-third and two-thirds of the surface. 3. Debris or calculus covers more than two-thirds of the surface. Good: 0.0 - 1.2 Fair: 1.3 - 3.0 Poor: 3.1 - 6.0
Gingival score
Time frame: 6 months
Gingival score assessed by the gingival score index: 0: Normal gingiva, no inflammation. 1. Mild inflammation - slight color change and edema (swelling), no bleeding on probing. 2. Moderate inflammation - redness, edema, glazing, and bleeding on probing. 3. Severe inflammation - marked redness, edema, ulceration, and tendency towards spontaneous bleeding. The index typically uses a scale of 0 to 3, with 0 representing normal gingiva and higher scores indicating increasing severity of inflammation
2 secondary outcomes
oral health practices
Time frame: 6 months
Oral Health Impact Profile.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Backgroundnsari Moghaddam S, Shahrzad S, Kermansaravi F. Effect of teach-back method on oral health indicators, self-efficacy, and self-care behaviors of high school students in Zahedan during 2019. J Mashhad Dent School. 2020;44(2):99-113.
- Results publication: PubMed 34256752Hashemi ZS, Khorsandi M, Shamsi M, Moradzadeh R. Effect combined learning on oral health self-efficacy and self-care behaviors of students: a randomized controlled trial. BMC Oral Health. 2021 Jul 13;21(1):342. doi: 10.1186/s12903-021-01693-y.
- Results publication: PubMed 35346148Sanaeinasab H, Saffari M, Taghavi H, Karimi Zarchi A, Rahmati F, Al Zaben F, Koenig HG. An educational intervention using the health belief model for improvement of oral health behavior in grade-schoolers: a randomized controlled trial. BMC Oral Health. 2022 Mar 27;22(1):94. doi: 10.1186/s12903-022-02132-2.
- Results publication: PubMed 34698662Hernandez-Vasquez A, Azanedo D. The urgency of ensuring equitable and improved access to oral health care during the Coronavirus Disease 2019 pandemic: The case of Peru. J Res Health Sci. 2021 Aug 28;21(3):e00528. doi: 10.34172/jrhs.2021.60.
- Individual participant dataSharing planned: No. Only the study protocol, statistical plan, and results will be shared in publications in peer-reviewed journals
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-Based Oral Health Promotion Program in people with Oral and Health, run by Universiti Putra Malaysia at 3 sites in Pakistan.
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 2 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Mehwish Raheem, MBBS, MPH (00923249479263, kiranmehwish47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque score (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07115433, which also lists 4 linked publications.
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 11 Aug 2025.