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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02999061
Other study ID # CEBC-CU-2016-12-169
Secondary ID
Status Completed
Phase N/A
First received December 15, 2016
Last updated July 23, 2017
Start date December 2016
Est. completion date June 2017

Study information

Verified date July 2017
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 383
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 5 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Cairo University Children's Hospital "Abo El-Rish" at El-Monira Cairo Governorate

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Brogårdh-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of dental caries. 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 Assessment of oral hygiene . 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
Secondary Assessment of dietary habits 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
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