- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05652231
Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children
March 3, 2023 updated by: Mennat Allah Ashraf A.Elsabour, Ahram Canadian University
Children from two orphanages will be examined for dental caries experience, in comparison to parented school children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A total of 156 children were included in this study, they were, residing in governmental orphanage, non-governmental orphanage and parented children attending primary school.
Written informed consent was obtained prior to the start of the study, form legal guardians or child's parent.
Dental examination was carried out on an ordinary chair beside a window on day light.
DMF and def indices were used to assess dental caries for primary and permanent teeth.
Also, unmet treatment need index, care index and significant caries index were calculated.
Study Type
Observational
Enrollment (Actual)
156
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt
- Ahram Canadian University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
apparently healthy children aged from six to12 years old
Description
Inclusion Criteria:
- apparently healthy children aged from six to12 years old
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
School children (control group)
parented school children (control group)
|
the child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF)
|
|
Non-Governmental orphanage children (exposed group 1)
|
the child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF)
|
|
Governmental orphanage children (exposed group 2)
|
the child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
caries experience
Time Frame: baseline record
|
measured using DMF/ def index
|
baseline record
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
January 1, 2023
Study Registration Dates
First Submitted
December 6, 2022
First Submitted That Met QC Criteria
December 6, 2022
First Posted (Actual)
December 15, 2022
Study Record Updates
Last Update Posted (Estimate)
March 6, 2023
Last Update Submitted That Met QC Criteria
March 3, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACU 111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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