Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000148774
Ethics application status
Approved
Date submitted
30/04/2021
Date registered
28/01/2022
Date last updated
28/01/2022
Date data sharing statement initially provided
28/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in Oral Health Knowledge from viewing Whatsapp Video and Infographics in Schoolchildren - A Randomized Control Trial
Scientific title
Oral Health Promotion through Whatsapp Video and Infographics in Schoolchildren - A Randomized Control Trial
Secondary ID [1] 303615 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Caries 320990 0
Gum health 322966 0
Condition category
Condition code
Oral and Gastrointestinal 318796 318796 0 0
Normal oral and gastrointestinal development and function
Public Health 322412 322412 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Oral health promotion Video

Oral health promotion material: Developed by the team Specialist dentists to suit children's age group and level of understanding.
Mode of delivery will be by Through whatss app to the Parents of the school children on their registered mobile numbers.
Number of times intervention of promotion material : Once
Contents of the video :1) Plaque and its role in oral diseases 2) Oral hygiene practices and care. 3) Benefits and proper use of fluoride 4) Dietary advice for oral health 5) Importance of regular dental attendance.
Duration of the video: 6-8 minutes
A post-test questionnaire to check oral health knowledge was given to the participants that measured their exposure to the video.

Intervention code [1] 319901 0
Prevention
Intervention code [2] 319902 0
Behaviour
Comparator / control treatment
Arm 2 : Oral health promotion Infographic

Oral health promotion material: Developed by the team Specialist dentists to suit children's age group and level of understanding.
Mode of delivery: Through whatss app to the Parents of the school children on their registered mobile numbers.
Number of times intervention of promotion material : Once
Contents of the infographic: 1) Plaque and its role in oral diseases 2) Oral hygiene practices and care. 3) Benefits and proper use of fluoride 4) Dietary advice for oral health 5) Importance of regular dental attendance.
Approximate duration that participants should spend engaging in the infographic: 4-5 minutes
A post-test questionnaire to check oral health knowledge was given to the participants that measured their exposure to the infographic.
Control group
Active

Outcomes
Primary outcome [1] 326741 0
Change in oral health knowledge as assessed by study-specific questionnaire
Timepoint [1] 326741 0
Outcome will be assessed at the 1) Baseline 2) One week post-intervention.
Secondary outcome [1] 392586 0

Parent's satisfaction, perceptions and feedback (a composite secondary outcome) as assessed by semi-structured interviews.
Timepoint [1] 392586 0
After three weeks of the intervention/s.

Eligibility
Key inclusion criteria
School Children aged between 9 to 12 years with informed consent from parents
Minimum age
9 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with special needs.

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)
Randomisation of school children into Video and Infographic group was computerised.
Posting of videos and infographic was led by teachers to parents' mobile phones, based on random lists provided by researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/08/2021
Date of last participant enrolment
Anticipated
Actual
19/08/2021
Date of last data collection
Anticipated
Actual
30/09/2021
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 23514 0
Malaysia
State/province [1] 23514 0
Melaka

Funding & Sponsors
Funding source category [1] 308034 0
University
Name [1] 308034 0
Manipal University College Malaysia
Country [1] 308034 0
Malaysia
Primary sponsor type
University
Name
Manipal University College Malaysia
Address
Faculty of Dentistry, Manipal University College Malaysia
Jalan Batu Hampar, Bukit Baru, Melaka , 75150, Malaysia
Country
Malaysia
Secondary sponsor category [1] 309305 0
None
Name [1] 309305 0
Address [1] 309305 0
Country [1] 309305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308029 0
Research and Ethics Committee, MUCM, Malaysia
Ethics committee address [1] 308029 0
Ethics committee country [1] 308029 0
Malaysia
Date submitted for ethics approval [1] 308029 0
31/01/2020
Approval date [1] 308029 0
03/07/2020
Ethics approval number [1] 308029 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109270 0
A/Prof DR ANKITA ARORA
Address 109270 0
Faculty of Dentistry, Manipal University College Malaysia
Jalan Batu Hampar, Bukit Baru, Malaysia, 75150
Country 109270 0
Malaysia
Phone 109270 0
+60172596982
Fax 109270 0
Email 109270 0
[email protected]
Contact person for public queries
Name 109271 0
DR ANKITA ARORA
Address 109271 0
Faculty of Dentistry, Manipal University College Malaysia
Jalan Batu Hampar, Bukit Baru, Malaysia, 75150
Country 109271 0
Malaysia
Phone 109271 0
+60172596982
Fax 109271 0
Email 109271 0
[email protected]
Contact person for scientific queries
Name 109272 0
DR ANKITA ARORA
Address 109272 0
Faculty of Dentistry, Manipal University College Malaysia
Jalan Batu Hampar, Bukit Baru, Malaysia, 75150
Country 109272 0
Malaysia
Phone 109272 0
+60172596982
Fax 109272 0
Email 109272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Its a oral health promotion trial being done on school children, individual data will not be shared


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
No additional documents have been identified.