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

NCT06602765 | Active Not Recruiting DMC

• 1 other identifier: BUHS-IRB#061/24
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fissure sealant; Fluoride; Caries; Saliva; Dietary counselling

Outcome Measures

Primary Outcomes (1)

• Prevention of dental Caries

  Compare the effectiveness of the combination of different preventive strategies which include tooth brushing with fluoride toothpaste, dietary counselling, and fissure sealant application for reducing the incidence of dental caries among school children

  1 year

Secondary Outcomes (2)

• Dietary Analysis

  1 year

• Streptococcus mutans in Saliva

  1 year

Study Arms (3)

tooth-brushing

ACTIVE COMPARATOR

In Control arm, tooth brushing with fluoride toothpaste using pea-sized toothpaste, using bass technique.

Other: Tooth brushing, tooth paste containing 1450ppm fluoride

tooth-brushing and dietary counselling

ACTIVE COMPARATOR

In intervention arm 1, tooth brushing with fluoride toothpaste using pea-sized toothpaste, using the bass technique, and dietary counselling.

Other: Tooth brushing, tooth paste containing 1450ppm fluoride

tooth-brushing , dietary counselling and fissure sealing of 1st permanent molar

ACTIVE COMPARATOR

In the intervention arm 2, tooth brushing with fluoride toothpaste using pea-sized toothpaste, using the bass technique, dietary counseling, and application of fissure sealant on a permanent first molar.

Other: Tooth brushing, tooth paste containing 1450ppm fluoride

Interventions

Tooth brushing, tooth paste containing 1450ppm fluoride OTHER

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

Also known as: dietary counselling, fissure sealent, Glassionomer cement

tooth-brushing; tooth-brushing , dietary counselling and fissure sealing of 1st permanent molar; tooth-brushing and dietary counselling

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Schoolchildren aged 6-7 years Sound 1st permanent molars Consent obtained from parents/guardians Cooperative Children

You may not qualify if:

• st Permanent molar has not erupted. Children with disability. Special Children (e.g. Down syndrome)

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

Pakistan Navy Educational Trust

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

Toothbrushing

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Officials

• Kulsoom F Rizvi, MSc

  Bahria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A single-blind trial will be conducted where the outcome assessor/statistician will be blind to the intervention received by the participants in different groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Control, Interventional group 1, Interventional group 2

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: September 19, 2024
• Study Start: October 5, 2024
• Primary Completion: November 5, 2025
• Study Completion: November 30, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)