- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04344366
Association Between Early Childhood Caries, Low Birth Weight and Nutritional Risk Factors: (Cohort Study)
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: dina morad
- Phone Number: 01150316543
- Email: dina_farrag@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
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
General Publications
- 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.
- Masumo R, Birungi N, Bardsen A, Fadnes LT, Astrom 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on ECC
-
Hospices Civils de LyonNot yet recruitingEarly Childhood Caries (ECC)France
-
Centre Hospitalier Universitaire DijonCompletedCoronary Artery Bypass Graft With or Without ECCFrance