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Comparative Analysis of Interventions for Prevention of Dental Caries in School Children

NCT06602765 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-09-23

No results posted yet for this study

Summary

A study aims to assess the most effective preventive interventions to address the widespread issue of dental caries, affecting an estimated 2 billion people in permanent teeth and over 500 million children in primary teeth globally. Notably, in Pakistan, over 90% of caries-affected teeth are untreated. Despite schools being a platform for public health initiatives, there is limited evidence on oral health promotion in low and middle-income countries. This study compares different preventive strategies' effectiveness and cost-efficiency for caries prevention in schoolchildren.

The randomized controlled trial will occur in Naval Schools of Karachi under the Pakistan Navy Educational Trust (PNET) over one year, including intervention and follow-up periods. The interventions include a combination of fluoride toothpaste, dietary counselling, and fissure sealant application. A multi-stage sampling method will select schools and classes, while convenience random sampling will select 180 children for the study. A single-blind trial will be conducted, with the data analyst unaware of the intervention groups.

Participants will be divided into three groups. Group 1 (Control) will use fluoride toothpaste and be instructed to brush twice daily. Group 2 (Intervention-1) will receive 14500 ppm fluoride toothpaste and oral health education. Group 3 (Intervention-2) will include the treatments from Group 2 plus fissure sealants on the first permanent molars. Parents in Groups 2 and 3 will receive a standardized advice sheet to reinforce oral hygiene practices at home.

The study will collect baseline demographic data, including age, gender, socioeconomic status, family education, existing oral hygiene practices, dental knowledge, and dentition status. Oral examinations will be conducted according to international standards. Statistical analysis will employ Chi-Square, ANOVA, and logistic regression tests, with a significance level set at 0.05.

The study aims to determine the most effective preventive strategy by comparing the reduction in dental caries incidence across the groups. The findings will guide recommendations for implementing the most effective intervention on a larger scale in schools, with the goal of reducing the burden of dental caries in children.

Conditions

  • Prevention of Dental Caries

Interventions

OTHER

Tooth brushing, tooth paste containing 1450ppm fluoride

brushing with fluoride toothpaste, dietary counselling for caries prevention and application of fissure sealant compound on first permanent t molars.

Sponsors & Collaborators

  • Bahria University

    lead OTHER

Principal Investigators

  • Kulsoom F Rizvi, MSc · Bahria University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-05
Primary Completion
2025-11-05
Completion
2025-11-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06602765 on ClinicalTrials.gov