NCT04186689

Brief Summary

identifying children with dental uncooperative behavior among those who suffered from food insecurity will enable to implement preventive strategies and early intervention. The aim of this study is to examine the relationship between food insecurity, maternal psychological status and child dental behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

November 26, 2019

Last Update Submit

June 21, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    which ranges from total cooperation (0) to no cooperation(6)

    6 months

  • 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)

    to measure the effect of the predictor variable and the potential mediators which are the household food insecurity and maternal psychological status respectively.

    6 months

Study Arms (3)

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.

Other: Routine Dental Examination

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.

Other: Routine Dental Examination

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.

Other: Routine Dental Examination

Interventions

Routine dental examination for the children Questionnaire for their mothers

children in food insecure households (G3)children in fully food secure households (G1)children in marginally food secure households (G2)

Eligibility Criteria

Age36 Months - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

study populations are healthy children (3-13 years old) having at least one tooth needs dental treatment, accompanied by their mothers on their first dental visit and whose mothers signed an informed consent were eligible to participate in the study. children were enrolled only if they had at least one carious tooth with ICDAS detection code for coronal caries ranging from 3 to 5. Children with mental, communicative or developmental disabilities were excluded.

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry- Ain Shams University

Cairo, Egypt

Location

Study Officials

  • Dina D Abd-Elmoneam, masters

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 5, 2019

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

June 24, 2026

Record last verified: 2026-06

Locations