NCT02999061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
383

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

December 15, 2016

Last Update Submit

July 23, 2017

Conditions

PreTerm Birth

Keywords

pre-term children

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessment of oral hygiene .

    12 month

  • Assessment of dietary habits

    12 month

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

population is limited to preterm birth children aged 2-5 years with primary teeth only , both genders are included.

You may qualify if:

  • Children aged 2-5 years old.
  • Presence of primary teeth only.
  • Children born preterm at gestational age of 6,7 and 8 month.

You may not qualify if:

  • Children with disability or mental disorders.
  • Children with immune compromising conditions.
  • Hospitalized and chronically ill children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Children's Hospital "Abo El-Rish" at El-Monira

Cairo Governorate, Egypt

Location

Related Publications (8)

  • 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.

    PMID: 18802992BACKGROUND

  • 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.

    PMID: 20877971BACKGROUND

  • 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.

    PMID: 15242381BACKGROUND

  • 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.

    PMID: 19732193BACKGROUND

  • 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.

    PMID: 9048413BACKGROUND

  • 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.

    PMID: 21911951BACKGROUND

  • 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.

    PMID: 17822485BACKGROUND

  • 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.

    PMID: 24731399BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Eman S Elmasry, Professor

    Cairo University

    STUDY DIRECTOR

  • Samah M Awad, Ass.Prof.

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 21, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 25, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)