Clinical trial NCT06523712: Effectiveness of Interactive Oral Care Lessons on Children Dental Health Practices
Official title: The Efficiency of an Oral Health Intervention in Promoting Better Oral Health Behaviors in Children Between the Ages of 5 to12 Years in a Low-income Nation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Plaque
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: University of Lahore
First posted: 2024-07-26
Enrollment: 1800
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In a parallel intervention study model, participants are divided into two or more distinct groups, with each group receiving a different intervention or treatment simultaneously. In this study, participants are not randomized into two arms: the experimental group (Arm 1) and the control group (Arm 2). The experimental group receives the interactive oral care lessons, while the control group does not receive any intervention and continues with their regular oral hygiene practices. Both groups are assessed at baseline and post-intervention to compare outcomes and evaluate the effectiveness of the intervention. This study design allows for the direct comparison of outcomes between the intervention and control groups, enabling researchers to determine the impact of the intervention on oral hygiene knowledge, behavior, and plaque control.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: It presents a randomized clinical trial to assess the effectiveness of interactive oral care lessons for children. It highlights the importance of oral health education during childhood and proposes using engaging teaching methods. The study involves baseline and post-intervention assessments, with participants randomly assigned to receive oral health education or serve as a control group. Data collected through questionnaires and plaque assessments will be analyzed to determine the impact of the intervention on oral hygiene habits.

Detailed description: It presents a comprehensive research plan aimed at assessing the effectiveness of interactive oral care lessons for children through a randomized clinical trial. It begins by emphasizing the crucial role of oral health education during childhood in establishing lifelong positive oral hygiene habits. The proposed study seeks to address this need by implementing interactive teaching methods tailored to engage young learners effectively.

The study will be conducted in a schools located in Lahore.

The inclusion criteria for participant selection specify children within the age range mentioned. In contrast, exclusion criteria include those who do not provide permission and consent from both children and their parents, as well as children with underlying systemic diseases or special healthcare needs.

Data collection procedures involve obtaining approval from the departmental research committee and gaining authorization from school principals. Discussions with parents will be scheduled to explain the research in detail and obtain written consent. The schools will then be randomly divided into two groups: Group I, receiving oral health education (experimental), and Group II, serving as the control.

The study will be conducted in three phases over six months:

Phase 1: Baseline Assessment Demographic information ,oral health questionnaires will be collected. Plaque assessment will be conducted using the Silness and Loe plaque index under natural lighting conditions.

Phase 2: Intervention Group I will receive comprehensive oral health education sessions covering topics such as the importance of teeth, brushing techniques, dental caries, and preventive measures.

Group II will not receive any intervention and will serve as the control. Phase 3: Post-Intervention Assessment Oral health-related knowledge and behavior will be reassessed using the same questionnaires.

Plaque assessment will be repeated using the Silness and Loe plaque index. Data analysis will involve Intention-to-treat analysis. The Shapiro-Wilk test will be applied to explore whether the data are normally distributed. Missing data will be reported. The mean and standard deviation will be presented for normal data, whereas for non-normal data, the median and interquartile ranges will be displayed. Frequencies and percentages will be used to depict categorical data. Differences in adherence scores between the two groups at 0 and 6 months for the primary and secondary outcomes, parametric tests (Independent samples t-test/Paired samples t-test), and nonparametric tests (Mann-Whitney U test /Wilcoxon signed-rank test) will be conducted on the data. P \< 0.05 will be used as the significance test. Data will be reported as to why it is missing. All analysis will be made using SPSS and R-Studio.

The outcome of the study aims to provide insights into the effectiveness of interactive oral care lessons on children dental health practices. The research schedule includes phases for data collection, data entry, data analysis, and article write-up.

Eligibility criteria: Inclusion Criteria:

* Age between 5 to 12 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 requiring immediate medical attention.
* Children with special needs affecting their ability to participate in the oral health education interventions.

Primary outcomes:
measure: DENTAL HEALTH PRACTICES AND BEHAVIOUR
timeFrame: 6 MONTHS
Secondary outcomes:
measure: PLAQUE SCORE
timeFrame: 6 MONTHS
measure: GINGIVAL SCORE
timeFrame: 6 MONTHS
measure: ORAL HEALTH RELATED QUALITY OF LIFE
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Lahore
name: MUHAMMAD ARSHED, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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