NCT06897956

Brief Summary

An orphan is defined as "a child under the age of 18 whose mother, father, both parents, and a primary caregiver has died, and who is in need of care or protection". Orphans, therefore, are considered disadvantaged and socially marginalized population whom diseases burden is high. Egypt has 1.7 million orphaned children. The number of children between the age of 0 and 17 who are currently registered in orphanages is 12,015. Dental diseases especially plaque, gingival and dental caries are highly preventable, with the highest prevalence in the developing countries. Profound disparities exist in oral health status across different social and economic divisions. The pattern of orphanage living is quite different from family living as the latter provides physical security, food, and shelter but is devoid of psychological security. High prevalence of dental caries, gingivitis and dental trauma has been observed in children of orphanages. This has been attributed to many factors such as: lack of adequate staff, poor oral hygiene, improper nutrition and eating patterns, high consumption of sugary food, negligence of tooth brushing, moreover the children and caregivers knowledge, level of education and oral health illiteracy. Untreated oral diseases could lead to psychological and general health problems, pain and loss in school time. Recognition of these problems is essential to provide optimum oral health for these deprived children. Health education is an important tool of public health and an effective primary preventive method especially for school aged children in controlling plaque, gingival and dental diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

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

Study Start

First participant enrolled

August 16, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 13, 2025

Last Update Submit

March 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oral hygiene knowledge, and practices of the orphan children

    Questionnaire including 20 questions about the oral hygiene knowledge and practices of the children. This questionnaire was used before the educational program and after 2 months from the program

    Before the educational program and after 2 months

Secondary Outcomes (3)

  • Dental Caries experience for permanent dentition

    Before the educational program and after 2 months

  • Dental Caries experience for mixed dentition

    Before the educational program and after 2 months

  • Oral hygiene

    Before the educational program and after 2 months

Study Arms (5)

Wadi Hof Orphanage children

Orphan children at that Wadi Hof Branch

Other: Oral health educational program

El-Doki Orphanage children

Orphan children at that El-Doki Branch

Other: Oral health educational program

Helwan Orphanage children

Orphan children at that Helwan Branch

Other: Oral health educational program

Misr Elgadida Orphanage children

Orphan children at that Misr Elgadida Branch

Other: Oral health educational program

6th October Orphanage children

Orphan children at that 6th October Branch

Other: Oral health educational program

Interventions

Oral health educational program about oral hygiene, prevention of dental caries and techniques of tooth brushing

6th October Orphanage childrenEl-Doki Orphanage childrenHelwan Orphanage childrenMisr Elgadida Orphanage childrenWadi Hof Orphanage children

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study is carried out at orphanages from different branches in Egypt. The study was conducted using a convenient sample of orphan children aged 7years and above.

You may qualify if:

  • Orphan Children aged 7 years old and above.
  • Educated children.
  • No learning difficulty.
  • No medical conditions.

You may not qualify if:

  • Any child that refuses to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

Dental CariesBehavior

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 13, 2025

First Posted

March 27, 2025

Study Start

August 16, 2022

Primary Completion

October 20, 2022

Study Completion

January 15, 2023

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations