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
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Nabih Raslan
Scientific

Department of Paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria

ORCiD logoORCID ID 0000-0001-9967-9575
Phone 999140726
Email raslan.nabih@tishreen.edu.sy
Dr Hasan Ali
Scientific

Department of Paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria

ORCiD logoORCID ID 0000-0001-6959-7552
Phone 943424206
Email hasan.h.ali@outlook.com
Dr Celine Al-jalki
Scientific

Department of Paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria

Phone 933001390
Email celinemelad2018@gmail.com

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet No participant information sheet available.
Scientific titleEnamel hypoplasia (EHP) as a predictive factor of early childhood caries (ECC): a cross-sectional study
Study objectivesEnamel 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) studiedEnamel hypoplasia, caries
InterventionMothers 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 typeOther
Primary outcome measurePresence 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 measuresRisk 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 date01/04/2017
Completion date30/11/2019

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit3 Years
SexBoth
Target number of participants300
Key inclusion criteria1. Aged between 1 and 3 years
2. Able and willing to cooperate with the examination
Key exclusion criteria1. Parents do not consent
2. Child has a disability or systematic disorder
Date of first enrolment20/04/2019
Date of final enrolment20/10/2019

Locations

Countries of recruitment

  • Syria

Study participating centre

Tishreen University
Department of Pediatric Dentistry, Tishreen University Latakia, Syria.
Latakia
00963
Syria

Sponsor information

Tishreen University
University/education

Department of Paediatric Dentistry
Faculty of Medical Dentistry
Lattakia
00963
Syria

Phone 00963(41)-427-510
Email dentistry@tishreen.edu.sy
Website http://www.tishreen.edu.sy
ROR logo "ROR" https://ror.org/04nqts970

Funders

Funder type

University/education

Tishreen University

No information available

Results and Publications

Intention to publish date10/11/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe 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.