NCT07011381

Brief Summary

This cross-sectional analytical study aims to assess and compare parental perceptions of oral health-related quality of life (OHRQoL) among Sudanese refugee children and Egyptian children aged 6-12 years living in Egypt. The study will include 192 child-parent pairs (96 Sudanese refugees and 96 Egyptians). Data will be collected via a validated Arabic questionnaire adapted from the Child Oral Health Impact Profile (COHIP) and clinical oral health examinations using DMFT/dmft indices, Gingival Index, and Plaque Index. The study seeks to identify disparities in oral health, parental awareness, and access to dental care services, thereby informing future community-based interventions and public health policies targeting vulnerable populations such as refugee children.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

May 9, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

dental cariesgingivitisoral healthrefugee health

Outcome Measures

Primary Outcomes (1)

  • Mean Total Score on the Child Oral Health Impact Profile (COHIP) Questionnaire

    Measured using the validated Arabic version of the Child Oral Health Impact Profile (COHIP) questionnaire. Total score and domain-specific subscores (Oral Health, Functional Well-being, Emotional Well-being, School Environment, and Self-image) will be analyzed. Full name: Child Oral Health Impact Profile (COHIP), Arabic version Score range: 0 to 140 Higher scores = better oral health-related quality of life

    Baseline (single clinical visit at enrollment)

Secondary Outcomes (1)

  • Clinical Oral Health Status

    Baseline (Day 1, clinical oral examination)

Study Arms (2)

Sudanese Refugee Children Group

Children aged 6-12 years residing in \[location\], identified as Sudanese refugees. Participants will undergo clinical oral health assessment and complete a child oral health quality of life questionnaire (COHIP). Parental perception will be documented through structured interviews.

Egyptian Children Group

Children aged 6-12 years residing in \[location\], identified as native Egyptian citizens. Participants will undergo clinical oral health assessment and complete the same COHIP questionnaire. Parental perception will also be recorded via interviews.

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Sudanese refugee and Egyptian children aged 6-12 years attending selected schools and community centers in Cairo, Egypt.

You may qualify if:

  • Children aged 6-12 years
  • Either Sudanese refugee or Egyptian national
  • Resident in Cairo for at least 1 year
  • Informed consent obtained from parent or legal guardian

You may not qualify if:

  • Systemic health conditions affecting oral health
  • Ongoing orthodontic treatment
  • Children with special health care needs or developmental disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University, Faculty of Oral and Dental Medicine

Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, 33511, Egypt

Location

MeSH Terms

Conditions

Dental CariesGingivitis

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2025

First Posted

June 8, 2025

Study Start

June 10, 2025

Primary Completion

July 10, 2025

Study Completion

November 20, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations