Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000395235
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
16/03/2018
Date last updated
16/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
E-Learning for improving oral health of children.
Scientific title
The effectiveness of a health education program based on E-Learning versus leaflets in promoting oral hygiene practice of school children.
Secondary ID [1] 294080 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral hygiene 306644 0
Dental caries 306643 0
Gingivitis 306645 0
Level of oral health knowledge 306651 0
Condition category
Condition code
Public Health 305836 305836 0 0
Health promotion/education
Oral and Gastrointestinal 305744 305744 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Educational programs promoting oral health of schoolchildren.
Dental caries has been considered to be a major public health problem for Syrian children, moreover, many challenges can be faced in providing access and delivering oral health care to children in Syria. Therefore, it is thought wise to increase preventative care in the form of school-based health education programs aiming at children. However, there are no previous studies that compare the effects of two different educational methods (E-learning versus leaflets) on oral health promotion geared for school children. So the present study aimed to determine if E-learning instructions improve the acquisition of oral health knowledge and skills when compared to traditional educational leaflets in children aged 10-11 years living in Damascus city. Also, to consequently determine which educational method can better direct the child towards practicing appropriate oral health care.
The educational tools included:
Arm 1- Leaflets: 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. The leaflet is now provided in step 9, attachments 2 and 3.
Arm 2- E-learning program: 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.

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 with 5 years’ experience in Pediatric dentistry clinically examined all children in their classroom using mirror, probe and artificial light. 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 (once) face to face 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.
The investigator used a web tracker (statcounter.com) to be sure of the adherence of subjects visiting the website under investigation (oralhealthforchildren.com). As for Leaflet cluster, subjects were asked face to face if they did read the leaflet.
Intervention code [1] 300352 0
Prevention
Comparator / control treatment
Comparator treatment was the educational leaflet, which is an alternate form of educational aids.
Control group
Active

Outcomes
Primary outcome [1] 304818 0
Change in oral health knowledge level using a questionnaire designed specifically for the study, the Oral Health Questionnaire in now provided in Step 9, Attachment 1.
Timepoint [1] 304818 0
Oral health knowledge level was assessed at baseline, 6 [primary timepoint] and at 12 weeks of oral health education.
Secondary outcome [1] 343299 0
Change in gingival health using Gingival Index (GI) for Löe and Silness.
Timepoint [1] 343299 0
Gingival health was assessed at baseline, 6 and at 12 weeks of oral health education.
Secondary outcome [2] 343298 0
Change in plaque accumulation using Plaque Index (PI) for Silness and Löe.
Timepoint [2] 343298 0
Dental Plaque was assessed at baseline, 6 and at 12 weeks of oral health education.

Eligibility
Key inclusion criteria
All healthy children who accepted to take part in this study, who did not receive any previous dental educational program, had internet access connection and ability to browse and use the internet, were included in this study.
Minimum age
10 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children older or smaller than the age group specified in the study, also who visiting a dentist regularly or receiving dental health education through another source and/or physically or mentally or medically compromised children, and children with current poor oral hygiene due to an acute abscess or viral infection that did not permit oral examination, besides uncooperative children, or whose parents refused to participate were excluded from the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given an approximately equal cluster size, we estimated that a total of 200 children with 100 children in each cluster would be needed to detect a difference between clusters, with a two-tailed, a of 0.05 and a (1-ß) of 0.80. To allow adjustment of other factors such as withdrawals, missing data, lost to follow-up etc., additional subjects (20 subjects) were added to allow adjustment of other factors.
Statistical Analysis:
Data was entered in Microsoft Excel 2010, and statistically analyzed using the software SPSS 19.0. Descriptive statistical analysis was carried out. One way repeated measures ANOVA and post hoc Bonferroni test were used to compare the mean differences of study parameters (Oral health knowledge, PI scores and GI scores) within the same cluster. Between the two clusters, independent samples t-test was used to compare the mean differences of parameters evaluated at baseline, 6 weeks and 12 weeks. Level of significance and confidence interval were set at 5% and 95%, respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/01/2016
Date of last participant enrolment
Anticipated
Actual
25/01/2016
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
220
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 9594 0
Syrian Arab Republic
State/province [1] 9594 0
Damascus city

Funding & Sponsors
Funding source category [1] 298711 0
University
Name [1] 298711 0
Damascus University
Country [1] 298711 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Baramkeh Street
Damascus University Central administration, Damascus University
Damascus
Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 297885 0
University
Name [1] 297885 0
Faculty of Dentistry
Address [1] 297885 0
Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
Country [1] 297885 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299657 0
Ministry of Education
Ethics committee address [1] 299657 0
Ethics committee country [1] 299657 0
Syrian Arab Republic
Date submitted for ethics approval [1] 299657 0
Approval date [1] 299657 0
11/01/2016
Ethics approval number [1] 299657 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2429 2429 0 0
/AnzctrAttachments/374535-The second part of the educational leaflet.pdf (Other)
Attachments [2] 2427 2427 0 0
/AnzctrAttachments/374535-Oral Health Questionnaire.docx (Other)
Attachments [3] 2428 2428 0 0
/AnzctrAttachments/374535-The first part of the educational leaflet.pdf (Other)

Contacts
Principal investigator
Name 81198 0
Dr Susan Al Bardaweel
Address 81198 0
Charke Al Tejara
57 Antara Al Abse
9th Floor, apartment 2
Damascus
Syria
Country 81198 0
Syrian Arab Republic
Phone 81198 0
+963991433525
Fax 81198 0
Email 81198 0
susan.bardaweel@hotmail.co.uk
Contact person for public queries
Name 81199 0
Susan Al Bardaweel
Address 81199 0
Charke Al Tejara
57 Antara Al Abse
9th Floor, apartment 2
Damascus
Syria
Country 81199 0
Syrian Arab Republic
Phone 81199 0
+963991433525
Fax 81199 0
Email 81199 0
susan.bardaweel@hotmail.co.uk
Contact person for scientific queries
Name 81200 0
Susan Al Bardaweel
Address 81200 0
Charke Al Tejara
57 Antara Al Abse
9th Floor, apartment 2
Damascus
Syria
Country 81200 0
Syrian Arab Republic
Phone 81200 0
+963991433525
Fax 81200 0
Email 81200 0
susan.bardaweel@hotmail.co.uk

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseE-learning or educational leaflet: does it make a difference in oral health promotion? A clustered randomized trial.2018https://dx.doi.org/10.1186/s12903-018-0540-4
N.B. These documents automatically identified may not have been verified by the study sponsor.