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Effectiveness of Interactive Oral Care Lessons on Children Dental Health Practices

Not Applicable
Not yet recruiting
Conditions
Dental Plaque
Interventions
Behavioral: Smile Smarts
Registration Number
NCT06523712
Lead Sponsor
Universiti Putra Malaysia
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
1800
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.
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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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
intervention groupSmile SmartsThe participants assigned to Arm 1 will receive interactive oral care curriculum lessons designed to educate and engage them in oral hygiene practices. These lessons will cover various topics such as the importance of teeth, types of dentition, proper brushing techniques, prevention of dental caries, and the role of fluoride in maintaining oral health. The educational sessions will be delivered using interactive methods such as printed flashcards, games, and hands-on activities to enhance learning and retention. Participants will actively participate in the sessions, which will be tailored to their age group and comprehension level. The goal of Arm 1 is to assess the effectiveness of these interactive oral care lessons in improving oral hygiene knowledge, behavior, and plaque control among schoolchildren aged 5 to 12.
Primary Outcome Measures
NameTimeMethod
DENTAL HEALTH PRACTICES AND BEHAVIOUR6 MONTHS

The primary outcome is dental health practices and behaviour will be assessed using a pre-validated questionnaire derived from a reference study with a reliability score of 0.719. The questionnaire comprises 12 questions, where questions 1-6 pertain to awareness and questions 7-12 assess practices. The scoring range is from 0 to 12, with higher scores indicating better dental health practices and behavior.

Secondary Outcome Measures
NameTimeMethod
ORAL HEALTH RELATED QUALITY OF LIFE6 months

Oral Health-Related Quality of Life is a vital measure that reflects the broader implications of oral health on an individual's life. By understanding and improving OHRQoL, healthcare providers and policymakers can enhance the overall health and well-being of individuals and communities.

GINGIVAL SCORE6 MONTHS

The other secondary outcome is gingival score will be measured using the Silness and Löe gingival index. This index assesses the severity of gingivitis based on color, consistency, and bleeding on probing. The scoring range is from 0 to 3, with 0 indicating healthy gums and 3 indicating severe inflammation.

Scoring Criteria: Assess gingival inflammation at four sites around each tooth (mesial, distal, buccal, and lingual)

PLAQUE SCORE6 MONTHS

The secondary outcome is Plaque score will be measured using the Silness and Löe plaque index. This index scores the thickness of dental plaque at the gingival margin. The scoring range is from 0 to 3, with 0 indicating no plaque and 3 indicating a high amount of plaque accumulation.

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