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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04344366
Other study ID # ECC in LBW children
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date July 1, 2021

Study information

Verified date July 2020
Source Cairo University
Contact dina morad
Phone 01150316543
Email dina_farrag@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date July 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 36 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (2)

da Silva Castro CR, de Sousa Cabral MBB, Mota ELA, Cangussu MCT, Vianna MIP. Analysis of the influence of low birth weight on the time of eruption of dental caries in children in early childhood. J Public Health Dent. 2019 Dec;79(4):292-297. doi: 10.1111/jphd.12322. Epub 2019 May 13. — View Citation

Masumo R, Birungi N, Bårdsen A, Fadnes LT, Astrøm AN. Impact of low birthweight on early childhood caries in 6-36 months old infants in Uganda: A cross-sectional study. Acta Odontol Scand. 2014 May;72(4):312-20. doi: 10.3109/00016357.2014.880189. Epub 2014 Jan 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary early childhood caries Dental examination 1 year
Secondary Nutritional risk factors questionnaire 1 year