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

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ClinicalTrials.gov Identifier: NCT02999061
Recruitment Status : Completed
First Posted : December 21, 2016
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ohoud Tawfig ZainElabdeen, Cairo University

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

Condition or disease
PreTerm Birth

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


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Study Type : Observational
Actual Enrollment : 383 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition: Across Sectional Study
Study Start Date : December 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999061


Locations
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Egypt
Cairo University Children's Hospital "Abo El-Rish" at El-Monira
Cairo Governorate, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Eman S Elmasry, Professor Cairo University
Study Director: Samah M Awad, Ass.Prof. Cairo University

Publications:

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Responsible Party: Ohoud Tawfig ZainElabdeen, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT02999061     History of Changes
Other Study ID Numbers: CEBC-CU-2016-12-169
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ohoud Tawfig ZainElabdeen, Cairo University:
pre-term children

Additional relevant MeSH terms:
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Premature Birth
Dental Caries
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases