- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04186689
Relationship Between Food Insecurity and Child Dental Behavior (FI)
Relationship Between Food Insecurity, Maternal Psychological Status, and Child Dental Behavior: A Cross-Sectional Study
Study Overview
Status
Intervention / Treatment
Detailed Description
A well-trained investigator will collect data on maternal age (in years), the marital status, the educational levels of both parents and their employment status, pregnancy information, as well as family structure (whether children are living with both parents or not), number of siblings (none, one, two, or ≥three). Information on family monthly income and crowding index which is defined as the average number of people per room, excluding both the kitchen and bathrooms will be also obtained.
The level of household food insecurity will be determined using the validated Arabic version of the Household Food Insecurity Access Scale (HFIAS) which categorizes food insecurity into three levels (food secure, marginally food secure and food insecure) where the final score is given according to the sum of affirmative responses to the tool statements and the higher the score the more the level of food insecurity.
The validated Arabic version of the 14-item Perceived Stress Scale will be used to measure the self-reported level of stress among mothers of the enrolled children by assessing their feelings and thoughts during the last month. The level of child's dental behavior will be assessed during the initial oral examination before starting any dental treatment procedures using the six-point Venham behavior rating scale which ranges from total cooperation (0) to no cooperation
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt
- faculty of dentistry- Ain shams university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- Healthy children (3-13 years old) having at least one tooth needs dental treatment
- Accompanied by their mothers on their first dental visit
- whose mothers signed an informed consent children were enrolled only if they had at least one carious tooth with ICDAS for coronal caries ranging from 3 to 5.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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children in fully food secure households (G1)
preschool children live in a fully food secure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience.
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Routine dental examination for the children Questionnaire for their mothers
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|
children in marginally food secure households (G2)
preschool children live in a marginally food secure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience.
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Routine dental examination for the children Questionnaire for their mothers
|
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children in food insecure households (G3)
preschool children live in a food-insecure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience.
|
Routine dental examination for the children Questionnaire for their mothers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A six-point Venham Behavior Rating Scale to evaluate the child behavior during dental examination scale score from(0)the best outcome to (6) worst outcome
Time Frame: 6 months
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which ranges from total cooperation (0) to no cooperation(6)
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6 months
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questionnaire containing 2 scales Household Food Insecurity Access Scale( score food secure better outcome -severely food insecure the worst outcome) and 14-item Perceived Stress Scale (scores from 0 better outcome to 40 worst outcome)
Time Frame: 6 months
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to measure the effect of the predictor variable and the potential mediators which are the household food insecurity and maternal psychological status respectively.
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6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dina D Abd-Elmoneam, masters, Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 829 (CPP Ouest VI (Brest))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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