Association Between Early Childhood Caries, Low Birth Weight and Nutritional Risk Factors: (Cohort Study)

July 13, 2020 updated by: dina farrag morad, Cairo University
The aim of this study is to assess the ECC experience in children aged from 12 to 36 month with low birth weight children in comparison to normal birth weight.

Study Overview

Status

Unknown

Conditions

Detailed Description

Dental caries is on the top list of most widespread chronic diseases in addition to be a major public health issue. Dental caries is the single most common chronic childhood disease; it is 5 times more common than asthma, 7 times more common than hay fever and 14 times more common than chronic bronchitis. Deciduous tooth decay was ranked as the 12th most prevalent condition, affecting 560 million children in the 2015 Global Burden of Disease Study.

Low birth weight and premature birth are highly related to infant mortality, perinatal infections and the poor growth and development of children. Some risk groups have been identified, and attention should be focused on them so that preventive and health promotion measures are taken in an attempt to reverse this situation. One of these risk groups is composed of children born prematurely. Prematurity may be a predisposing factor for the development of caries.

There is a strong relationship between birth weight and infant mortality and morbidity and chronic diseases later in life. Many studies discussed the association between birth weight and dental caries however the results were conflicting. Knowledge of the association between low birth weight and the risk factors of ECC and the associated nutritional risk factors will improve the preventive and health promotion measures for this population.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy, children aged from 12 to 36 month.

Description

Inclusion Criteria:

  • Healthy children.
  • Children aged from 12 to 36 month.

Exclusion Criteria:

  • Refusal of participation from the parents.
  • Medically compromised children
  • Major illness
  • Child with special needs
  • Any systemic disease that may affect caries experience.
  • Any congenital deformity that may affect caries experience.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
group A
children with low birth weight
group B
children with normal birth weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early childhood caries
Time Frame: 1 year
Dental examination
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional risk factors
Time Frame: 1 year
questionnaire
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ola Omar, Professor of Pediatric Dentistry and Dental Public Health
  • Study Chair: Marwa Ali, Lecturer of Pediatric Dentistry and Dental Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

April 12, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECC in LBW children

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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