NCT05652231

Brief Summary

Children from two orphanages will be examined for dental caries experience, in comparison to parented school children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 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

November 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

December 6, 2022

Last Update Submit

March 3, 2023

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

  • caries experience

    measured using DMF/ def index

    baseline record

Study Arms (3)

School children (control group)

parented school children (control group)

Diagnostic Test: caries assessment

Non-Governmental orphanage children (exposed group 1)

Diagnostic Test: caries assessment

Governmental orphanage children (exposed group 2)

Diagnostic Test: caries assessment

Interventions

caries assessmentDIAGNOSTIC_TEST

the child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF)

Governmental orphanage children (exposed group 2)Non-Governmental orphanage children (exposed group 1)School children (control group)

Eligibility Criteria

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

apparently healthy children aged from six to12 years old

You may qualify if:

  • apparently healthy children aged from six to12 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahram Canadian University

Giza, Egypt

Location

Related Publications (1)

  • Khattab NMA, Abd-Elsabour MAA. Assessment of dental caries among a group of institutionalized orphan children compared to parented school children: case-control study. BMC Oral Health. 2023 Apr 5;23(1):202. doi: 10.1186/s12903-023-02915-1.

    PMID: 37020200DERIVED

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 15, 2022

Study Start

November 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)