Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition

July 23, 2017 updated by: Ohoud Tawfig ZainElabdeen, Cairo University

Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition: Across Sectional Study

The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.

PICO format:- Population (P) = preterm children aged 2-5 years attending Cairo University Children's Hospital "Abo El-Rish" at El-Monira, Cairo, Egypt.

Outcome (O) =prevalence of dental caries

Study Type

Observational

Enrollment (Actual)

383

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

      • Cairo Governorate, Egypt
        • Cairo University Children's Hospital "Abo El-Rish" at El-Monira

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

2 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

population is limited to preterm birth children aged 2-5 years with primary teeth only , both genders are included.

Description

Inclusion Criteria:

  • Children aged 2-5 years old.
  • Presence of primary teeth only.
  • Children born preterm at gestational age of 6,7 and 8 month.

Exclusion Criteria:

  • Children with disability or mental disorders.
  • Children with immune compromising conditions.
  • Hospitalized and chronically ill children.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of dental caries.
Time Frame: 12 month
measured by counting the number of participants affected by dental caries/total number of study sample X100 , measurement unit is a percentage (%)
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of oral hygiene .
Time Frame: 12 month

using a Questionnaire (binary' yes or no questions'):-

  • record child brushing habits(once or twice)
  • consumption of fluoridated water (yes/no).
  • visits to dentists (yes/no)
  • Also using a dental mirror and a probe to detect presence of plaque (plaque index) and presence of caries (dmf score).
12 month
Assessment of dietary habits
Time Frame: 12 month

questionnaire (binary "yes/no questions")about the past and current feeding habits:-

  • initial feeding of the child (breast or bottle answered yes/no)
  • length of the breast feeding ( normal '0-2 years" or prolonged ">2years")
  • usage of bottle after weaning (yes/no). number of meals per day (one,two or three, answered in yes/no manner)
  • number of snacks per day (one,two or three in yes/no answers).
  • Also using a dental mirror and a probe to detect caries presence (dmf score), higher scores indicates faulty dietary habits.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Eman S Elmasry, Professor, Cairo University
  • Study Director: Samah M Awad, Ass.Prof., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 23, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on PreTerm Birth

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