ECCNCT04344366
Association Between Early Childhood Caries, Low Birth Weight and Nutritional Risk Factors: (Cohort Study)
An observational study of ECC and LBW Children, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- ECC, LBW Children
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy, children aged from 12 to 36 month.
Who may be able to join
- Healthy children.
- Children aged from 12 to 36 month.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- ECC, LBW Children
- Keywords
- ECC, premature birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group A | children with low birth weight | |
| group B | children with normal birth weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
early childhood caries
Dental examination
Measured: 1 year
Secondary outcomes (1)
Nutritional risk factors
questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ECCStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dina farrag morad, Cairo University
- Investigators
- Ola Omar, Study director, Professor of Pediatric Dentistry and Dental Public HealthMarwa Ali, Study chair, Lecturer of Pediatric Dentistry and Dental Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344366
- Sponsor's protocol ID
- ECC in LBW children
- Status last verified
- Jul 2020
- First submitted
- 5 Feb 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31087372Masumo 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.
PubMed 24460034
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Early Childhood Caries, Low Birth Weight and Nutritional Risk Factors: (Cohort Study)
- ClinicalTrials.gov ID
- NCT04344366
- Acronym / sponsor ID
- ECC in LBW children
- Conditions
- ECC, LBW Children
- Keywords
- ECC, premature birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | –children with low birth weight |
| group B | – | –children with normal birth weight |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy, children aged from 12 to 36 month.
Key inclusion criteria (2 listed)
- Healthy children.
- Children aged from 12 to 36 month.
Key exclusion criteria (6 listed)
- Refusal of participation from the parents.
- Medically compromised children
- Major illness
- Child with special needs
- Any systemic disease that may affect caries experience.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
early childhood caries
Time frame: 1 year
Dental examination
1 secondary outcome
Nutritional risk factors
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 31087372da 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.
- Background: PubMed 24460034Masumo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola Omar study director
Professor of Pediatric Dentistry and Dental Public Health
Marwa Ali study chair
Lecturer of Pediatric Dentistry and Dental Public Health
Questions about this trial
What is this clinical trial studying?
An observational study of ECC and LBW Children, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dina morad (01150316543, dina_farrag@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early childhood caries (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344366, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.