Adolescent, Cluster Randomized Trial, Dental Plaque, Health Promotion, Oral Hygiene, Oral Health, Pakistan
Conditions
Keywords
School-based intervention, Oral health promotion, Adolescent health (LMICs), Equity-focused intervention, Cluster randomized trial
Brief 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. 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.
Interventions
BEHAVIORALSmile Smarts
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.
Sponsors
Universiti Putra Malaysia
University of Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
In this study, masking, also known as blinding, refers to the practice of concealing the allocation of participants to intervention groups from outcome assessors and investigators involved in data collection and analysis. Masking helps minimize bias that could occur if those assessing the outcomes are aware of the participants' assigned interventions. In this case, both the outcome assessors and investigators are masked, meaning they are unaware of which participants received the interactive oral care lessons (experimental group) and which participants were in the control group.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Hygiene Status | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PLAQUE SCORE | 12 months | 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. |
| Observed toothbrushing performance | 12 months | 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. |
| Self-Reported Oral Hygiene Behaviors | 12 months | 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 |
| Mothers' Knowledge, Attitudes, and Practices (KAP) | 12 months | 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). |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORMUHAMMAD ARSHED, PhD
University of Lahore
Outcome results
None listed