Condition category
Oral Health
Date applied
30/03/2019
Date assigned
16/04/2019
Last edited
18/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nabih Raslan

ORCID ID

http://orcid.org/0000-0001-9967-9575

Contact details

Department of Paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria
999140726
raslan.nabih@tishreen.edu.sy

Type

Scientific

Additional contact

Dr Hasan Ali

ORCID ID

http://orcid.org/0000-0001-6959-7552

Contact details

Department of Paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria
943424206
hasan.h.ali@outlook.com

Type

Scientific

Additional contact

Dr Celine Al-jalki

ORCID ID

Contact details

Department of Paediatric Dentistry
Faculty of Medical Dentistry
Tishreen University
Lattakia
00963
Syria
933001390
celinemelad2018@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

U1111-1230-8903

Study information

Scientific title

Enamel hypoplasia (EHP) as a predictive factor of early childhood caries (ECC): a cross-sectional study

Acronym

Study hypothesis

Enamel hypoplasia could be a predictive factor of early childhood caries.

Ethics approval

Approved 25/07/2017, The Institutional Review Board of Tishreen University (Latakia, Syria; no other contact details available at present), ref: 1789

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available.

Condition

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

Phase

Drug names

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 trial start date

01/04/2017

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged between 1 and 3 years
2. Able and willing to cooperate with the examination

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Parents do not consent
2. Child has a disability or systematic disorder

Recruitment start date

20/04/2019

Recruitment end date

20/10/2019

Locations

Countries of recruitment

Syria

Trial participating centre

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

Sponsor information

Organisation

Tishreen University

Sponsor details

Department of Paediatric Dentistry
Faculty of Medical Dentistry
Lattakia
00963
Syria
00963(41)-427-510
dentistry@tishreen.edu.sy

Sponsor type

University/education

Website

http://www.tishreen.edu.sy

Funders

Funder type

University/education

Funder name

Tishreen University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
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.

Intention to publish date

10/11/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/04/2019: Internal review. 15/04/2019: Trial's existence confirmed by Tishreen University.