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Trial record 39 of 1216 for:    tooth decay

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

Tracking Information
First Submitted Date December 15, 2016
First Posted Date December 21, 2016
Last Update Posted Date July 25, 2017
Study Start Date December 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 16, 2016)
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 (%)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02999061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 16, 2016)
  • 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).
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition
Official Title Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition: Across Sectional Study
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.
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
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition PreTerm Birth
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 16, 2016)
383
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT02999061
Other Study ID Numbers CEBC-CU-2016-12-169
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ohoud Tawfig ZainElabdeen, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators
Study Director: Eman S Elmasry, Professor Cairo University
Study Director: Samah M Awad, Ass.Prof. Cairo University
PRS Account Cairo University
Verification Date July 2017