Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523712
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-15
Brief Title:
Effectiveness of Interactive Oral Care Lessons on Children Dental Health Practices
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-testPaired samples t-test and nonparametric tests Mann-Whitney U test Wilcoxon signed-rank test will be conducted on the data P 005 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
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-testPaired samples t-test and nonparametric tests Mann-Whitney U test Wilcoxon signed-rank test will be conducted on the data P 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None