Clinical trial NCT02999061: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PreTerm Birth
Keywords: pre-term children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 383
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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

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.

Primary outcomes:
measure: Prevalence of dental caries.
timeFrame: 12 month
Secondary outcomes:
measure: Assessment of oral hygiene .
timeFrame: 12 month
measure: Assessment of dietary habits
timeFrame: 12 month
Other outcomes:
Locations:
city: Cairo Governorate
country: Egypt
facility: Cairo University Children's Hospital "Abo El-Rish" at El-Monira
Study officials:
affiliation: Cairo University
name: Eman S Elmasry, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Samah M Awad, Ass.Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1590/s1806-83242010000300012.
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. doi: 10.1111/j.1365-263X.2004.00557.x.
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.
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.
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.
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. doi: 10.1111/j.1600-0528.2006.00345.x.
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.