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Completed

NCT Number: NCT02999061

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

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

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University Children's Hospital "Abo El-Rish" at El-Monira

Cairo Governorate, Egypt

About this 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.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 (%)

Secondary outcomes

  1. 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).
  2. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2016
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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