Dental PlaqueNCT06523712
A Scalable, Teacher-delivered, School-based Oral Health Intervention for Pakistani Lower Secondary Schoolchildren
A study testing Smile Smarts in people with Dental Plaque and Cluster Randomized Trial, run by Universiti Putra Malaysia at 1 site in Pakistan.
Trial summary
This was a pragmatic, two-arm, and parallel-group, superiority cluster-randomized controlled trial with 1:1 allocation of clusters (schools) to either the Smile Smarts-PK intervention arm or the control arm. The trial settings were lower secondary schools (classes 5-8) in the Punjab, Pakistan. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Cluster Randomized Trial, Adolescent
- What is being tested?
- Smile Smarts
- 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
- 4,055 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jul 2024to 15 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 10 to 15 years. Enrollment at one of the selected schools.
- Consent obtained from parents or legal guardians for participation in the study.
Who cannot join
- Children and their parents who did not give assent and consent to participate in the study.
- Children with severe oral health issues require immediate medical attention.
- Children with special needs affecting their ability to participate in the oral health education interventions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Scalable, Equity-focused, Teacher-delivered, School-based Oral Health Intervention for Pakistani Lower Secondary Schoolchildren: a Pragmatic Cluster-randomized Effectiveness-implementation Trial (Smile Smarts-PK)
This was a pragmatic, two-arm, and parallel-group, superiority cluster-randomized controlled trial with 1:1 allocation of clusters (schools) to either the Smile Smarts-PK intervention arm or the control arm. The trial settings were lower secondary schools (classes 5-8) in the Punjab, Pakistan. Punjab is the most populous province of Pakistan; it has many public and low-cost private schools that serve lower- and middle-income communities.
Read the detailed description
Oral diseases are among the most common non-communicable conditions affecting children worldwide and disproportionately burden those in low- and middle-income countries. Robust evidence from pragmatic, theory-informed, school-based cluster-randomized trials in South Asia remains scarce. We evaluated the effectiveness of Smile Smarts-PK, a scalable teacher-delivered oral health intervention embedded within routine lower secondary school systems in Pakistan.
Methods It is a parallel, pragmatic, school-level cluster-randomized controlled trial in 50 lower secondary schools in Pakistan. Schools were randomly assigned (1:1) to either the Smile Smarts-PK intervention or usual school practice. The intervention was teacher-delivered, integrated into routine academic schedules, and informed by the Health Belief Model. Primary outcomes at 12 months were clinical oral health indices: Debris Index-Simplified (DI-S), Calculus Index-Simplified (CI-S), Oral Hygiene Index-Simplified (OHI-S). Secondary outcomes included plaque index, children's oral health knowledge, observed and self-reported oral health behaviours, and maternal knowledge, attitudes, and practices. Analyses were by intention to treat using linear mixed-effects models accounting for clustering at the school level.
- Conditions
- Dental Plaque, Cluster Randomized Trial, Adolescent, Oral Hygiene, Oral Health, Health Promotion, Pakistan
- Being tested
- Smile Smarts
- Keywords
- School-based intervention, Oral health promotion, Adolescent health (LMICs), Equity-focused intervention, Cluster randomized trial
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smile SmartsBehavioural
The interactive oral health care lessons provided to participants in Arm 1 would involve activities and discussions aimed at changing behaviors such as tooth brushing frequency, brushing techniques, and the use of interdental aids. The intervention aims to educate and motivate participants to adopt and maintain optimal oral hygiene habits through behavioral change strategies.
| Study group | Role | What they receive |
|---|---|---|
| Smile Smarts-PK | Experimental | The intervention group is given the Smile Smarts-PK intervention. It is s a multi-theory, multicomponent oral health promotion intervention grounded in a multi-level theoretical framework integrating the Health Belief Model (HBM) and Social Cognitive Theory (SCT). In addition, the delivery strategy is viewed through an implementation science lens, implementation theory, to strengthen understanding not only of effectiveness but also of reach, adoption, fidelity, and future maintenance. Receives: Behavioral: Smile Smarts |
| Control group | No intervention | Participants assigned to Arm 2 serve as the control group and do not receive any intervention during the study except for routine school activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Hygiene Status
The change in the Simplified Oral Hygiene Index (OHI-S) from baseline to 12 months served as the primary endpoint. The OHI-S scores debris and calculus on six index surfaces (scores 0-3 each), with the summed component means creating an overall score ranging from 0 (good hygiene) to 6 (poor hygiene). Scores were categorized as good (0.0-1.2), fair (1.3-3.0), or poor (3.1-6.0). The primary analysis focused on the change in mean OHI-S score at both the individual and cluster levels
Measured: 12 month
Secondary outcomes (4)
PLAQUE SCORE
The secondary outcome is Plaque score will be measured using the Silness and Löe plaque index. This index scores the thickness of dental plaque at the gingival margin. The scoring range is from 0 to 3, with 0 indicating no plaque and 3 indicating a high amount of plaque accumulation.
Measured: 12 months
Observed toothbrushing performance
The change in toothbrushing performance from baseline to 12 months was assessed using a validated 12-item checklist. Each item was scored from 0 (poor) to 2 (good), yielding a total score of 0-24, categorized as poor (0-11), fair (12-17), or good (18-24). Analysis focused on changes in mean scores and the proportion of children in each category.
Measured: 12 months
Self-Reported Oral Hygiene Behaviors
Changes in self-reported oral hygiene behaviors from baseline to 12 months were measured using a validated 12-item questionnaire covering brushing frequency and fluoride use. Total scores ranged from 0 to 24, with classifications of poor (0-11), fair (12-17), or good
Measured: 12 months
Mothers' Knowledge, Attitudes, and Practices (KAP)
The third secondary outcome was the assessment of change in mothers' knowledge, attitudes, and practices (KAP) related to oral hygiene from baseline to 12 months. Data were collected using standardized Likert-scale and multiple-choice items. Response formats, including true/false, Likert scales, and multiple-choice questions, were standardized to allow calculation of summary scores: knowledge (% correct), attitudes (mean Likert score), and practices (categorical frequencies).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start25 Jul 2024
- Primary completion24 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies 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 a parallel, pragmatic, school-level cluster-randomized controlled trial in 50 lower secondary schools in Pakistan. Schools were randomly assigned (1:1) to either the Smile Smarts-PK intervention or usual school practice.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
- Investigators
- MUHAMMAD ARSHED, PhD, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523712
- Sponsor's protocol ID
- UOL
- Status last verified
- Apr 2026
- First submitted
- 15 Jun 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Halawany HS, Al Badr A, Al Sadhan S, Al Balkhi M, Al-Maflehi N, Abraham NB, Jacob V, Al Sherif G. Effectiveness of oral health education intervention among female primary school children in Riyadh, Saudi Arabia. Saudi Dent J. 2018 Jul;30(3):190-196. doi: 10.1016/j.sdentj.2018.04.001. Epub 2018 May 4.
PubMed 29942102Wahengbam PP, Kshetrimayum N, Wahengbam BS, Nandkeoliar T, Lyngdoh D. Assessment of Oral Health Knowledge, Attitude and Self-Care Practice Among Adolescents - A State Wide Cross- Sectional Study in Manipur, North Eastern India. J Clin Diagn Res. 2016 Jun;10(6):ZC65-70. doi: 10.7860/JCDR/2016/20693.8002. Epub 2016 Jun 1.
PubMed 27504414Carvalho AP, Moura MF, Costa FO, Cota LO. Correlations between different plaque indexes and bleeding on probing: A concurrent validity study. J Clin Exp Dent. 2023 Jan 1;15(1):e9-e16. doi: 10.4317/jced.60039. eCollection 2023 Jan.
PubMed 36755682Hilgert LA, Leal SC, Bronkhorst EM, Frencken JE. Long-term Effect of Supervised Toothbrushing on Levels of Plaque and Gingival Bleeding Among Schoolchildren. Oral Health Prev Dent. 2017;15(6):537-542. doi: 10.3290/j.ohpd.a39593.
PubMed 29319063Pine C, Adair P, Robinson L, Burnside G, Moynihan P, Wade W, Kistler J, Curnow M, Henderson M. The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial. Trials. 2016 Feb 20;17(1):103. doi: 10.1186/s13063-016-1226-3.
PubMed 26897029Florio FM, Dos Santos Klee L, Brandao Ramos AP, Ambrosano GMB, de Souza Fonseca Silva A. Use of Water by Schoolchildren: Impact of Indirectly Supervised Daily Toothbrushing-A Pilot Study. Int J Clin Pediatr Dent. 2020 Sep-Oct;13(5):513-517. doi: 10.5005/jp-journals-10005-1800.
PubMed 33623340Salama FS, Al-Balkhi BK. Effectiveness of educational intervention of oral health for special needs on knowledge of dental students in Saudi Arabia. Disabil Health J. 2020 Jan;13(1):100789. doi: 10.1016/j.dhjo.2019.03.005. Epub 2019 Mar 19.
PubMed 31495647Swe KK, Soe AK, Aung SH, Soe HZ. Effectiveness of oral health education on 8- to 10-year-old school children in rural areas of the Magway Region, Myanmar. BMC Oral Health. 2021 Jan 2;21(1):2. doi: 10.1186/s12903-020-01368-0.
PubMed 33388030
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scalable, Equity-focused, Teacher-delivered, School-based Oral Health Intervention for Pakistani Lower Secondary Schoolchildren: a Pragmatic Cluster-randomized Effectiveness-implementation Trial (Smile Smarts-PK)
- ClinicalTrials.gov ID
- NCT06523712
- Acronym / sponsor ID
- UOL
- Conditions
- Dental Plaque, Cluster Randomized Trial, Adolescent, Oral Hygiene, Oral Health, Health Promotion, Pakistan
- Keywords
- School-based intervention, Oral health promotion, Adolescent health (LMICs), Equity-focused intervention, Cluster randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,055 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 26 Jul 2024 (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.
This was a pragmatic, two-arm, and parallel-group, superiority cluster-randomized controlled trial with 1:1 allocation of clusters (schools) to either the Smile Smarts-PK intervention arm or the control arm. The trial settings were lower secondary schools (classes 5-8) in the Punjab, Pakistan. Punjab is the most populous province of Pakistan; it has many public and low-cost private schools that serve lower- and middle-income communities.
Detailed description
Oral diseases are among the most common non-communicable conditions affecting children worldwide and disproportionately burden those in low- and middle-income countries. Robust evidence from pragmatic, theory-informed, school-based cluster-randomized trials in South Asia remains scarce. We evaluated the effectiveness of Smile Smarts-PK, a scalable teacher-delivered oral health intervention embedded within routine lower secondary school systems in Pakistan.
Methods It is a parallel, pragmatic, school-level cluster-randomized controlled trial in 50 lower secondary schools in Pakistan. Schools were randomly assigned (1:1) to either the Smile Smarts-PK intervention or usual school practice. The intervention was teacher-delivered, integrated into routine academic schedules, and informed by the Health Belief Model. Primary outcomes at 12 months were clinical oral health indices: Debris Index-Simplified (DI-S), Calculus Index-Simplified (CI-S), Oral Hygiene Index-Simplified (OHI-S). Secondary outcomes included plaque index, children's oral health knowledge, observed and self-reported oral health behaviours, and maternal knowledge, attitudes, and practices. Analyses were by intention to treat using linear mixed-effects models accounting for clustering at the school level.
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 a parallel, pragmatic, school-level cluster-randomized controlled trial in 50 lower secondary schools in Pakistan. Schools were randomly assigned (1:1) to either the Smile Smarts-PK intervention or usual school practice.
| Arm | Type | Receives |
|---|---|---|
| Smile Smarts-PK | Experimental | Behavioral: Smile SmartsThe intervention group is given the Smile Smarts-PK intervention. It is s a multi-theory, multicomponent oral health promotion intervention grounded in a multi-level theoretical framework integrating the Health Belief Model (HBM) and Social Cognitive Theory (SCT). In addition, the delivery strategy is viewed through an implementation science lens, implementation theory, to strengthen understanding not only of effectiveness but also of reach, adoption, fidelity, and future maintenance. |
| Control group | No intervention | –Participants assigned to Arm 2 serve as the control group and do not receive any intervention during the study except for routine school activities |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 10 to 15 years. Enrollment at one of the selected schools.
- Consent obtained from parents or legal guardians for participation in the study.
Key exclusion criteria (3 listed)
- Children and their parents who did not give assent and consent to participate in the study.
- Children with severe oral health issues require immediate medical attention.
- Children with special needs affecting their ability to participate in the oral health education 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 |
|---|---|---|
| Smile SmartsThe interactive oral health care lessons provided to participants in Arm 1 would involve activities and discussions aimed at changing behaviors such as tooth brushing frequency, brushing techniques, and the use of interdental aids. The intervention aims to educate and motivate participants to adopt and maintain optimal oral hygiene habits through behavioral change strategies. | Behavioural | Smile Smarts-PK |
Primary outcome
Oral Hygiene Status
Time frame: 12 month
The change in the Simplified Oral Hygiene Index (OHI-S) from baseline to 12 months served as the primary endpoint. The OHI-S scores debris and calculus on six index surfaces (scores 0-3 each), with the summed component means creating an overall score ranging from 0 (good hygiene) to 6 (poor hygiene). Scores were categorized as good (0.0-1.2), fair (1.3-3.0), or poor (3.1-6.0). The primary analysis focused on the change in mean OHI-S score at both the individual and cluster levels
4 secondary outcomes
PLAQUE SCORE
Time frame: 12 months
Observed toothbrushing performance
Time frame: 12 months
Self-Reported Oral Hygiene Behaviors
Time frame: 12 months
Mothers' Knowledge, Attitudes, and Practices (KAP)
Time frame: 12 months
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 16 Apr 2026.
- Results publication: PubMed 29942102Halawany HS, Al Badr A, Al Sadhan S, Al Balkhi M, Al-Maflehi N, Abraham NB, Jacob V, Al Sherif G. Effectiveness of oral health education intervention among female primary school children in Riyadh, Saudi Arabia. Saudi Dent J. 2018 Jul;30(3):190-196. doi: 10.1016/j.sdentj.2018.04.001. Epub 2018 May 4.
- Results publication: PubMed 27504414Wahengbam PP, Kshetrimayum N, Wahengbam BS, Nandkeoliar T, Lyngdoh D. Assessment of Oral Health Knowledge, Attitude and Self-Care Practice Among Adolescents - A State Wide Cross- Sectional Study in Manipur, North Eastern India. J Clin Diagn Res. 2016 Jun;10(6):ZC65-70. doi: 10.7860/JCDR/2016/20693.8002. Epub 2016 Jun 1.
- Results publication: PubMed 36755682Carvalho AP, Moura MF, Costa FO, Cota LO. Correlations between different plaque indexes and bleeding on probing: A concurrent validity study. J Clin Exp Dent. 2023 Jan 1;15(1):e9-e16. doi: 10.4317/jced.60039. eCollection 2023 Jan.
- Results publication: PubMed 29319063Hilgert LA, Leal SC, Bronkhorst EM, Frencken JE. Long-term Effect of Supervised Toothbrushing on Levels of Plaque and Gingival Bleeding Among Schoolchildren. Oral Health Prev Dent. 2017;15(6):537-542. doi: 10.3290/j.ohpd.a39593.
- Results publication: PubMed 26897029Pine C, Adair P, Robinson L, Burnside G, Moynihan P, Wade W, Kistler J, Curnow M, Henderson M. The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial. Trials. 2016 Feb 20;17(1):103. doi: 10.1186/s13063-016-1226-3.
- Results publication: PubMed 33623340Florio FM, Dos Santos Klee L, Brandao Ramos AP, Ambrosano GMB, de Souza Fonseca Silva A. Use of Water by Schoolchildren: Impact of Indirectly Supervised Daily Toothbrushing-A Pilot Study. Int J Clin Pediatr Dent. 2020 Sep-Oct;13(5):513-517. doi: 10.5005/jp-journals-10005-1800.
- Results publication: PubMed 31495647Salama FS, Al-Balkhi BK. Effectiveness of educational intervention of oral health for special needs on knowledge of dental students in Saudi Arabia. Disabil Health J. 2020 Jan;13(1):100789. doi: 10.1016/j.dhjo.2019.03.005. Epub 2019 Mar 19.
- Results publication: PubMed 33388030Swe KK, Soe AK, Aung SH, Soe HZ. Effectiveness of oral health education on 8- to 10-year-old school children in rural areas of the Magway Region, Myanmar. BMC Oral Health. 2021 Jan 2;21(1):2. doi: 10.1186/s12903-020-01368-0.
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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.
MUHAMMAD ARSHED, PhD principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smile Smarts in people with Dental Plaque and Cluster Randomized Trial, run by Universiti Putra Malaysia at 1 site 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 3 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 16 Apr 2026. 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 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?
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?
Oral Hygiene Status (time frame: 12 month). 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 NCT06523712, which also lists 8 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 16 Apr 2026.