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Cluster RCT on the Effect of the Topics Number in Oral Health Educational Video Among Preschool Children.

NCT06073392 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-10-11

No results posted yet for this study

Summary

Purpose: This cluster randomized controlled trials study aims to investigate whether different number of topics delivered through educational video affect the oral health status, knowledge, attitude and practice of preschool children.

Hypothesis: The hypothesis of this study is the number of topics covered in educational videos aimed at preschool children will have a direct impact on their oral health status.

The specific hypothesis is the educational videos covering wide range of oral health topics will lead to better oral health outcomes in preschool children compared to videos focusing on limited number of topics. The higher number of topics delivered in educational video, the better oral health status, knowledge, attitude, and practice.

The alternative hypothesis is the combination of three topics on effective toothbrushing technique, effects of sugary food, and dental caries is effective to led to the most improvement in oral health status, knowledge, attitudes, and practices compared to two or only one topic.

Objectives: The objectives of this study were divided into primary and secondary.

The primary objective of the study is to assess the effect of different number of topics in educational video versus placebo video on mean difference in plaque score and gingival score among preschool children at baseline and 4 weeks after intervention.

The secondary objective is to assess the effect of different number of topics in educational video versus placebo video on mean difference in knowledge, attitude and practice score among preschool children at baseline and 4 weeks after intervention.

Participants: The study will involve 124 preschool children aged five to six years old.

Methods: Researchers will randomize classes in the school into five clusters using closed enveloped technique. These five clusters will be randomly assigned either into interventional groups or control groups. There are four intervention groups and one control group. Each intervention group will be compared to a control group for mean difference in plaque, gingival and KAP score at baseline and after intervention.

Duration: The study is expected to last 6 months (from subjects recruitment to final research report) with regular updates on progress.

Location: The study will be conducted at a preschool in Kota Bharu Kelantan.

Conditions

  • Oral Health

Interventions

OTHER

Educational video

Educational video in animation mode

Sponsors & Collaborators

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • SITI NUR BAIDURI MOHD JAINI · SCHOOL OF DENTAL SCIENCES, UNIVERSITI SAINS MALAYSIA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-11-30
Completion
2023-12-31

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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 NCT06073392 on ClinicalTrials.gov