The study aimed to compare between the traditional educational leaflets and E-applications in improving oral health knowledge, oral hygiene and gingival health in schoolchildren of Damascus city, Syria.
Design
Two arm parallel group, clustered randomized controlled trial
Settings and conduct
The trial was conducted at two public primary schools of Damascus city, Syria. Schools were randomly allocated into two clusters: Children in Leaflet cluster received oral health education through leaflets, and children in E-learning cluster received oral health education through an E-learning program. A trained investigator clinically examined all children in their classroom. This was performed without informing children about oral examination and intervention dates. Dental Plaque was assessed using Plaque Index (PI) for Silness and Löe. Gingival health was assessed using Gingival Index (GI) for Löe and Silness. After collecting the baseline data, oral health educational tools were provided to subjects in which leaflets were given to children in Leaflet cluster, whilst children in E-learning cluster were provided with CDs which contained instructions on how to access the website via the link www.oralhealthforchildren.com. The level of oral health knowledge, plaque accumulation and gingival status were also re-evaluated after a period of six weeks and also after twelve weeks by the same investigator.
Participants/Inclusion and exclusion criteria
All healthy children aged 10-11 year old from the selected schools were included in the study. Children receiving dental health education through another source and/or physically or mentally compromised children were excluded from the study.
Intervention groups
Intervention group 1: Leaflets, Intervention group 2: E-learning program.
Main outcome variables
Change in oral health knowledge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180214038729N1
Registration date:2018-03-21, 1397/01/01
Registration timing:retrospective
Last update:2018-03-21, 1397/01/01
Update count:0
Registration date
2018-03-21, 1397/01/01
Registrant information
Name
Susan Bardaweel
Name of organization / entity
Damascus University
Country
Syrian Arab Republic
Phone
+963 11 446 5707
Email address
susan.bardaweel@hotmail.co.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-24, 1394/11/04
Expected recruitment end date
2016-01-24, 1394/11/04
Actual recruitment start date
2016-01-25, 1394/11/05
Actual recruitment end date
2016-01-25, 1394/11/05
Trial completion date
empty
Scientific title
The effectiveness of a health education program based on E-Learning versus leaflets in promoting oral hygiene practice of school children.
Public title
E-Learning for improving oral health of children.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All healthy children who accepted to take part in this study
Children who did not receive any previous dental educational program
Children who had internet access connection and ability to browse and use the internet
Exclusion criteria:
children outside the age range of the study
children currently under the regular care of an oral health care provider
children who have access to oral health education through a different and separate source than our intervention
children with acute dental issues (e.g.: dental abscess)
mentally or physically compromised children
children whose parents did not provide consent for participation in our study
Age
From 10 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
220
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using coin-tossing.
The unit of randomization was the school.
Allocation is not concealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ministry of Education
Street address
Al-Mazraa, Al-Shahbandar Square, Ministry of Education, Damascus, Syria
City
Damascus
Postal code
Not applicable
Approval date
2016-01-11, 1394/10/21
Ethics committee reference number
252
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
2
Description of health condition studied
Oral hygiene
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Gingivitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
4
Description of health condition studied
Level of oral health knowledge
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in oral health knowledge level
Timepoint
Oral health knowledge level was assessed at baseline, 6 and at 12 weeks of oral health education.
Method of measurement
Oral health knowledge level was assessed using a questionnaire designed specifically for the study
Secondary outcomes
1
Description
Change in plaque accumulation
Timepoint
Dental Plaque was assessed at baseline, 6 and at 12 weeks of oral health education.
Method of measurement
Plaque accumulation was assessed using Plaque Index (PI) for Silness and Löe.
2
Description
Change in gingival health.
Timepoint
Gingival health was assessed at baseline, 6 and at 12 weeks of oral health education.
Method of measurement
Gingival health was assessed using Gingival Index (GI) for Löe and Silness.
Intervention groups
1
Description
Intervention group 1: Leaflet group: A colorful and attractive leaflet in the form of a short story named “Adnan likes the dentist” was designed by a graphic designer. The leaflets were designed with particular emphasis on creating interest amongst the children. These educational papers included information related to proper brushing technique and frequency; introduced the regular use of dental floss; emphasized regular dental visits as well as provided basic demonstration of dental plaque and the implications of not removing it. The leaflets also contained nutritional guidelines in regards to minimizing caries risk, and finally the role of fluoride in caries control.
Category
Prevention
2
Description
Intervention group 2: E-learning group: An E-learning program was designed by an expert in artificial intelligence. The program was full of colorful images, videos, interactive quizzes and age-related developmental tasks in the quest to deliver the information in an interactive, entertaining and simple manner. The E-learning program included the same information of the leaflet; only the way in which the content is conveyed to the children was different.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Beirouni school
Full name of responsible person
Rana Kabtoul
Street address
West Tejara, Al Beirouni school, Damascus, Syria
City
Damascus
Postal code
Not applicable
Phone
+963 11 446 0085
Email
amal-omry88@hotmal.com
2
Recruitment center
Name of recruitment center
Mary Alajami school
Full name of responsible person
Berna Kabalan
Street address
George Khouri square, Mary Alajami school, kassaa, Damascus, Syria
City
Damascus
Postal code
Not applicable
Phone
+963 11 446 2868
Email
berna.kabalan.ed@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Damascus University/ Faculty of Dentistry
Full name of responsible person
Prof. Mohammad Salem Rekab
Street address
Mazzah Highway, Faculty of Dentistry, Damascus, Syria
City
Damascus
Postal code
Not applicable
Phone
+963 11 212 1635
Fax
+963 11 212 4757
Email
dean.dent@damasuniv.edu.sy
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Damascus University/ Faculty of Dentistry
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Damascus University
Full name of responsible person
Susan Bardaweel
Position
Master student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Antara Alabsi street, East Tejara, Ninth floor, Apartment 2, Damascus, Syria
City
Damascus
Province
Damascus
Postal code
Not applicable
Phone
+963 11 446 5707
Email
susan.bardaweel@hotmail.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Damascus University
Full name of responsible person
Susan Bardaweel
Position
Master student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Antara Alabsi street, East Tejara, Ninth floor, Apartment 2, Damascus, Syria
City
Damascus
Province
Damascus
Postal code
Not applicable
Phone
+963 11 446 5707
Email
susan.bardaweel@hotmail.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Damascus University
Full name of responsible person
Susan Bardaweel
Position
Master student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Antara Alabsi street, East Tejara, Ninth floor, Apartment 2, Damascus, Syria
City
Damascus
Province
Damascus
Postal code
Not applicable
Phone
+963 11 446 5707
Email
susan.bardaweel@hotmail.co.uk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study Protocol, Statistical Analysis, Clinical Study Report, Leaflets used in the study, Oral Health Questionnaire
When the data will become available and for how long
Immediately following publication. Ending 5 years following publication
To whom data/document is available
Researchers who provide a methodologically sound proposal
Under which criteria data/document could be used
Data could be used for academic research only, and could not be available for third party without agreement of the authors.
Also, available data will be written in Arabic language and its use should be either in Arabic or in an English translation after verifying the translation with the author, exception of the Leaflets and Oral Health Questionnaire because there is an English versions.
From where data/document is obtainable
Directly from the author at susan.bardaweel@hotmail.co.uk
What processes are involved for a request to access data/document
The author will respond to the applicant within one week of receiving his/her request by e-mail, but final data providing will be within three months.
Comments
We do not have postal code in Syria.
I do not have professional email address