NCT04186689

Brief Summary

identifying children with dental anxiety 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
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Typical duration 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 year until next milestone

Study Start

First participant enrolled

December 20, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

November 26, 2019

Last Update Submit

February 18, 2025

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 pre-school 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

Age40 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

study populations are healthy pre-school children( 3.5-6 years old)having at least one tooth needs dental treatment, accompanied by their mothers.

You may qualify if:

  • Age range 3.5-6 years
  • Having at least one tooth with dental caries indicated for dental treatment under local anesthesia other than extraction
  • Visiting the dental clinic for the first time

You may not qualify if:

  • Children with the following criteria will be totally excluded from the study: Have any medical/neurological, communicative or developmental disorders as well as children with special healthcare needs.

Contact the study team to confirm eligibility.

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

December 20, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations