- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02999061
Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition
Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition: Across Sectional Study
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Cairo Governorate, Egypt
- Cairo University Children's Hospital "Abo El-Rish" at El-Monira
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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'):-
|
12 month
|
|
Assessment of dietary habits
Time Frame: 12 month
|
questionnaire (binary "yes/no questions")about the past and current feeding habits:-
|
12 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eman S Elmasry, Professor, Cairo University
- Study Director: Samah M Awad, Ass.Prof., Cairo University
Publications and helpful links
General Publications
- Brogardh-Roth S, Stjernqvist K, Matsson L. Dental behavioural management problems and dental caries prevalence in 3- to 6-year-old Swedish children born preterm. Int J Paediatr Dent. 2008 Sep;18(5):341-7. doi: 10.1111/j.1365-263x.2007.00884.x.
- Cruvinel VR, Gravina DB, Azevedo TD, Bezerra AC, Toledo OA. Prevalence of dental caries and caries-related risk factors in premature and term children. Braz Oral Res. 2010 Jul-Sep;24(3):329-35. doi: 10.1590/s1806-83242010000300012.
- Davenport ES, Litenas C, Barbayiannis P, Williams CE. The effects of diet, breast-feeding and weaning on caries risk for pre-term and low birth weight children. Int J Paediatr Dent. 2004 Jul;14(4):251-9. doi: 10.1111/j.1365-263X.2004.00557.x.
- Seow WK, Lam JH, Tsang AK, Holcombe T, Bird PS. Oral Streptococcus species in pre-term and full-term children - a longitudinal study. Int J Paediatr Dent. 2009 Nov;19(6):406-11. doi: 10.1111/j.1365-263X.2009.01003.x. Epub 2009 Sep 1.
- Lai PY, Seow WK, Tudehope DI, Rogers Y. Enamel hypoplasia and dental caries in very-low birthweight children: a case-controlled, longitudinal study. Pediatr Dent. 1997 Jan-Feb;19(1):42-9.
- Rajshekar SA, Laxminarayan N. Comparison of primary dentition caries experience in pre-term low birth-weight and full-term normal birth-weight children aged one to six years. J Indian Soc Pedod Prev Dent. 2011 Apr-Jun;29(2):128-34. doi: 10.4103/0970-4388.84685.
- Saraiva MC, Bettiol H, Barbieri MA, Silva AA. Are intrauterine growth restriction and preterm birth associated with dental caries? Community Dent Oral Epidemiol. 2007 Oct;35(5):364-76. doi: 10.1111/j.1600-0528.2006.00345.x.
- Tanaka K, Miyake Y. Low birth weight, preterm birth or small-for-gestational-age are not associated with dental caries in young Japanese children. BMC Oral Health. 2014 Apr 14;14:38. doi: 10.1186/1472-6831-14-38.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBC-CU-2016-12-169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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