Designing and Developing an Oral Health Educational Game and Evaluating its Effect on 8-12-year-old Children’s Oral Health
Design
Clinical experimental study with parallel groups, without blindness of participants but blindness of reasercher was done, randomized, was used on 40 patients.
Settings and conduct
The study will be conducted in a private dental office and since the educational game will be presented in the intervention group, it is not possible to blind the participants, but the evaluator was blind to the assignment of the groups.
Participants/Inclusion and exclusion criteria
participants:patients aged 8-12 years referring to a private dental clinic
Inclusion criteria:children aged 8-12 years
exclusion criteria:Children who were beyond the range of age 8-12 years, have mental disabilities, are illiterate in reading and writing, are unfamiliar with the Persian language, are treated with antimicrobial mouthwash or use fixed orthodontic appliances
Intervention groups
The experimental group received game-based training. In the experimental group, the children and their parents took part in an introduction session and received some explanations about the game. In the waiting room, the child was shown how to play a game with the healthcare provider (researcher) acting as a facilitator. It took about 30 minutes to complete the game. The game was then given to the children for home practice and repetition, with a focus on parental supervision and parents playing with their children. Only oral hygiene advice was provided to the control group.
Main outcome variables
Oral health is assessed using the Simplified Oral Hygiene Index(OHIS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210911052431N1
Registration date:2021-09-12, 1400/06/21
Registration timing:prospective
Last update:2021-09-12, 1400/06/21
Update count:0
Registration date
2021-09-12, 1400/06/21
Registrant information
Name
Azin Nourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8100
Email address
azin.nourian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
2021-09-23, 1400/07/01
Actual recruitment end date
2021-10-23, 1400/08/01
Trial completion date
2021-10-23, 1400/08/01
Scientific title
Designing and Developing an Oral Health Educational Game and Evaluating its Effect on 8-12-year-old Children’s Oral Health
Public title
Effect of Oral Health Educational Game on Children’s Oral Health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
8-12-year-old Children
Exclusion criteria:
Children who were beyond the range of age 8-12 years
Children with mental disabilities
Children who are illiterate in reading and writing
Children who are unfamiliar with the Persian language
Children who are treated with antimicrobial mouthwash
Children who use fixed orthodontic appliances
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization was used to allocate two study groups to intervention and control groups. six permutations were utilized with blocks of size of four including ABAB, AABB, ABBA, BAAB, BABA and BBAA (A: intervention group, B: control group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, due to the educational game provided to patients, it was not possible to blind the participants, but the evaluator who was blinded to the group’s allocation, in all stages.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
mahdavi Bolvar, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2020-02-05, 1398/11/16
Ethics committee reference number
IR.ZUMS.REC.1398.451
Health conditions studied
1
Description of health condition studied
Oral hygiene index
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Simplified Oral hygiene index(OHI-S)
Timepoint
Measurement of simplified oral hygiene index before intervention, one week and one month after intervention
Method of measurement
Observation with dental mirror and explorer is done and checklist of Simplified oral hygiene index is completed.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group received game-based training. In the experimental group, the children and their parents took part in an introduction session and received some explanations about the game. In the waiting room, the child was shown how to play a game with the healthcare provider (researcher) acting as a facilitator. It took about 30 minutes to complete the game. The game was then given to the children for home practice and repetition, with a focus on parental supervision and parents playing with their children.
Category
N/A
2
Description
Control group: Only oral hygiene advice was provided to the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Private dental clinic
Full name of responsible person
Azin Nourian
Street address
Saadi Bolvar, Bagheri Avenue, No 307
City
Zanjan
Province
Zanjan
Postal code
4515613984
Phone
+98 24 3333 2655
Email
azin.nourian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azin Nourian
Street address
Mahdavi Bolvar, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3314 8100
Email
info@zums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
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
Zanjan University of Medical Sciences
Full name of responsible person
Azin Nourian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Master of Science in Medical Education
Street address
Mahdavi Bolvar, Zanjan Dental School
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3344 7877
Email
azin.nourian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azin Nourian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Master of Science in Medical Education
Street address
Bolvar Mahdavi,Zanjan Dental School
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3314 8100
Email
azin.nourian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azin Nourian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mahdavi Blvd, Zanjan Dental School, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3314 8100
Fax
Email
azin.nourian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Information about the main outcome can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is possible to use it if you get a valid license from academic and scientific centers.
From where data/document is obtainable
Zanjan Dental School, Orthodontic department, Dr Azin Nourian
What processes are involved for a request to access data/document
After reviewing the valid license of academic and scientific centers, it is possible to submit.