Investigating the relationship between enamel defects, tooth decay, the mother's health during pregnancy and the child's health during their first year in children aged 1-3 years
ISRCTN | ISRCTN12808726 |
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DOI | https://doi.org/10.1186/ISRCTN12808726 |
Secondary identifying numbers | U1111-1230-8903 |
- Submission date
- 30/03/2019
- Registration date
- 16/04/2019
- Last edited
- 15/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Severe dental caries (tooth decay) in very young children is a serious problem. Decay could result in children losing their milk teeth. Sometimes, milk teeth may have structural defects that weaken the tooth and make it more likely to lose enamel (the hard coating of the tooth) through decay. The health of children during their first year when the milk teeth are developing or their mother's health throughout pregnancy can affect tooth development and cause these defects. This study aims to investigate the relationship between these defects and dental caries.
Who can participate?
Children aged between 1 and 3 years
What does the study involve?
Mothers visiting medical centers will be asked to participate in this study. If they approve, their children will have a dental examination, and the mothers will be asked some general questions about their health and their children's.
What are the possible benefits and risks of participating?
There are no risks to participants because they will not receive any treatment as part of the study. The children will have a dental check-up, which might identify decay that can then be treated.
Where is the study run from?
Tishreen University (Syria)
When is the study starting and how long is it expected to run for?
April 2019 to September 2019
Who is funding the study?
Tishreen University (Syria)
Who is the main contact?
1. Dr. Nabih Raslan (rasln.nabih@tishreen.edu.sy)
2. Dr. Hasan Ali (hasan.h.ali@outlook.com)
3. Dr. Celine Al-Jalky. (celinemelad2018@gmail.com)
Contact information
Scientific
Department of Paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria
0000-0001-9967-9575 | |
Phone | 999140726 |
raslan.nabih@tishreen.edu.sy |
Scientific
Department of Paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria
0000-0001-6959-7552 | |
Phone | 943424206 |
hasan.h.ali@outlook.com |
Scientific
Department of Paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria
Phone | 933001390 |
---|---|
celinemelad2018@gmail.com |
Study information
Study design | Observational cross-sectional study |
---|---|
Primary study design | Observational |
Secondary study design | Cross sectional study |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | No participant information sheet available. |
Scientific title | Enamel hypoplasia (EHP) as a predictive factor of early childhood caries (ECC): a cross-sectional study |
Study objectives | Enamel hypoplasia could be a predictive factor of early childhood caries. |
Ethics approval(s) | Approved 25/07/2017, The Institutional Review Board of Tishreen University (Latakia, Syria; no other contact details available at present), ref: 1789 |
Health condition(s) or problem(s) studied | Enamel hypoplasia, caries |
Intervention | Mothers visiting medical centers will be asked to participate in this study. If they approve, their children will have a dental examination. Dental examination will be achieved after gentle wiping of the teeth from food remnants using cotton. One dentist will check the outer surface of the front teeth and the upper surface of back teeth (molars) in daylight against a window. In addition, mothers will be asked some general questions about their children's health status. The mother will be interviewed by the same dentist, and will be asked many question about her child's health status. Questions will relate to: 1. The type of delivery (natural or Caesarean) 2. Smoking (for the mother: yes/no) 3. Medications (for the mother throughout pregnancy, and the baby throughout the first year of life) 4. The mother's weight at the time of labour and the baby's weight immediately after birth 5. Presence of anemia during pregnancy 6. Diseases affecting the baby throughout the first year of life These questions were developed by the research team based on the probable risk factors presented in previous similar studies. All procedures will be done at the same time for each mother-child pair without any follow-up. |
Intervention type | Other |
Primary outcome measure | Presence of hypoplasia-associated severe early childhood caries (HAS-ECC) according to the scoring system of Caufield et al, 2012, which consists of 3 stages (0, 1 and 2, where 2 is the most severe) |
Secondary outcome measures | Risk factors such birth weight, birth type, infectious diseases affecting the mother throughout pregnancy, or her child in their first year of life. |
Overall study start date | 01/04/2017 |
Completion date | 30/11/2019 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 1 Year |
Upper age limit | 3 Years |
Sex | Both |
Target number of participants | 300 |
Key inclusion criteria | 1. Aged between 1 and 3 years 2. Able and willing to cooperate with the examination |
Key exclusion criteria | 1. Parents do not consent 2. Child has a disability or systematic disorder |
Date of first enrolment | 20/04/2019 |
Date of final enrolment | 20/10/2019 |
Locations
Countries of recruitment
- Syria
Study participating centre
Latakia
00963
Syria
Sponsor information
University/education
Department of Paediatric Dentistry
Faculty of Medical Dentistry
Lattakia
00963
Syria
Phone | 00963(41)-427-510 |
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dentistry@tishreen.edu.sy | |
Website | http://www.tishreen.edu.sy |
https://ror.org/04nqts970 |
Funders
Funder type
University/education
No information available
Results and Publications
Intention to publish date | 10/11/2019 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Nabih Raslan (raslan.nabih@tishreen.edu.sy), from 3 months after publication up to 3 years. Data will be available for researchers who provide a methodologically sound proposal. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 27/02/2019 | 15/05/2020 | Yes | No |
Editorial Notes
18/04/2019: Internal review.
15/04/2019: Trial's existence confirmed by Tishreen University.