Comparative Analysis of Interventions for Prevention of Dental Caries in School Children: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Bahria University
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Prevention of dental Caries
Study Overview
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.
Detailed Description
Ethical Approval approved by the BUHSC ethical committee. School administrations will be approached for permission. Consent forms will be sent to the parents of the children before the data collection visit. The data collection team comprised of 06 members will visit the selected schools. A signed consent form will be taken, and verbal consent will be obtained from the children as well. The children fulfilling the inclusion criteria will be sequenced as a list. Randomization will be done through SNOSE - a sequential number of opaque sealed envelopes will be done, and the students will then be allocated in 3 groups.
PI, Co-PI, and 05 team members will conduct oral examinations in the selected schoolyard or inside a classroom, following the standard international guidelines (WHO 2013). In addition, the baseline demographic data will also be collected comprising of age, gender, socioeconomic status (SES), family education and existing oral hygiene practices, dental knowledge, and dentition status by the parents and participants. Group 1 (Control) will be given fluoride toothpaste containing 1450 ppm Fluoride and will be asked to brush at least twice daily with a pea-sized amount of toothpaste, using the modified bass technique. This will be considered as control. Some intervention in the control group will also address the ethical issues. Parents will be guided for the tooth brushing.
Group 2 (Intervention -1) will be given fluoride toothpaste containing 1450 ppm Fluoride and will be asked to brush at least twice daily with a pea-sized amount of toothpaste and oral health education. A modified bass technique for tooth brushing will be used. Oral health education through audio-visual aids, pamphlets, and live demonstrations on study models will cover proper tooth brushing techniques, the use of a good toothbrush, and healthy eating habits, including special emphasis on proteins and dairy products and alternate use of sugars in daily routine. E.g. soft drinks that are high in sugar can be replaced with drinking milk and water.
Group 3 (Intervention -1) will be given fissure sealants on 1st permanent molar along with the strategy given to Group 2. Fissure sealing compounds, Glass ionomer will be used on school children who will qualify for inclusion criteria. Mobile Dental Unit and fissure sealant kit will be taken to the site and children will be provided fissure sealant in their setting.
In the intervention group (2 and 3) parents will also be given an Evidence-Based standardized parental advice sheet to reinforce instructions at home.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 6 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Schoolchildren aged 6-7 years Sound 1st permanent molars Consent obtained from parents/guardians Cooperative Children
Exclusion Criteria
- •1st Permanent molar has not erupted. Children with disability. Special Children (e.g. Down syndrome)
Outcomes
Primary Outcomes
Prevention of dental Caries
Time Frame: 1 year
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
Secondary Outcomes
- Dietary Analysis(1 year)
- Streptococcus mutans in Saliva(1 year)
Investigators
Kulsoom Rizvi
Professor
Bahria University