Protocol summary

Study aim
compare the plaque index and changes in the awareness and performance after oral hygiene instruction using the video and in-person educational techniques in children 9–11 years old
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 105 students. Simple randomization was done by students choosing even, odd and zero random numbers from inside the bag.
Settings and conduct
Four schools were randomly selected from the elementary schools in Birjand. Two schools from the areas that were in the upper socio-economic level of the society and two schools from the areas that were in the lower socio-economic level of the society were randomly selected. Similar Soft toothbrushes were provided and they were asked to brush their teeth at school before measuring the plaque index . In addition, a questionnaire whose validity and reliability had been confirmed was used to record the awareness and performance of each child in terms of orodental health. A disclosing agent was then given to each student to chew for one minute and then spit it out . Then, each student’s plaque index Immediately after the oral hygiene instruction, one week, and three months after it, was determined.
Participants/Inclusion and exclusion criteria
The inclusion criteria consisted of 9–11 years of age, no visual, hearing, and physical problems, and no dental (both educational and therapeutic) interventions in the past six months. The exclusion criteria consisted of wearing fixed or removable orthodontic appliances, no interest in participating in the study, and systemic conditions.
Intervention groups
In intervention group 1, in-person oral hygiene education In intervention group 2, audio- visual oral hygiene education In control group, No educational intervention was made.
Main outcome variables
Plaque Index score (PI); oral health evaluation score; Oral health performance score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230311057679N1
Registration date: 2023-05-07, 1402/02/17
Registration timing: retrospective

Last update: 2023-05-07, 1402/02/17
Update count: 0
Registration date
2023-05-07, 1402/02/17
Registrant information
Name
Fatemeh Esmaeilzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9664
Email address
fa.es.8860@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
2019-04-04, 1398/01/15
Actual recruitment end date
2019-04-21, 1398/02/01
Trial completion date
2019-07-21, 1398/04/30
Scientific title
Comparison of the effects of audio-visual and in-person oral health education on the plaque index, awareness and performance of 9‒11-year-old children
Public title
Investigating the impact of health education
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
9–11 years of age no visual, hearing, and physical problems no dental (both educational and therapeutic) interventions in the past six months
Exclusion criteria:
using fixed or removable orthodontic appliances no interest in participating in the study systemic conditions
Age
From 9 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 105
Actual sample size reached: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual randomization, random numbers were put into a thick cloth bag and each student was asked to choose a number at random, if the selected number is other than odd numbers, the student is in the first intervention group, which is in-person oral health education and if it is even, the student will be included in the second intervention group, which is audio-visual health education, and if the number is zero, the student will be included in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
By naming three different health education groups as A, B, and C, the principle investigator, who was a university professor and responsible for data collection and outcome assessors, was unaware of the health education method used in each group.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Central Organization of Birjand University of Medical Sciences, Ghaffari Street, Birjand, South Khorasan.
City
Birjand
Province
South Khorasan
Postal code
9717853076
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.BUMS.REC.1397.362

Health conditions studied

1

Description of health condition studied
Oral health, Plaque index
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Average dental plaque index
Timepoint
Immediately after intervention, 7 days after intervention, 3 months after the intervention
Method of measurement
O’Leary index

Secondary outcomes

1

Description
Change the level of awareness after oral health education
Timepoint
Before the intervention, immediately after the intervention, 7 days after the intervention, 3 months after the intervention
Method of measurement
WHO Oral Health Questionnaire for Children

2

Description
Change the level of performance after oral health education
Timepoint
Before the intervention, immediately after the intervention, 7 days after the intervention, 3 months after the intervention
Method of measurement
WHO Oral Health Questionnaire for Children

Intervention groups

1

Description
Intervention group 1: in-person oral health education
Category
Other

2

Description
Intervention group 2: audio-visual oral health education
Category
Other

3

Description
Control group: Health education was not given
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand University of Medical Sciences
Full name of responsible person
Mehrnaz Khademi
Street address
Central Organization of Birjand University of Medical Sciences, Ghaffari Street, Birjand, South Khorasan.
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Fax
Email
Mehr.kh6688@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Vice-Chancellor of Research of Birjand University of Medical Sciences
Street address
Central Organization of Birjand University of Medical Sciences, Ghaffari Street, Birjand, South Khorasan.
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
Mehr.kh6688@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Esmaeilzadeh
Position
Resident of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil Abad Avenue, Mashhad University of Medical Sciences, Dental School, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3882 9664
Email
EsmaeilzadehF991@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Esmaeilzadeh
Position
Resident of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil Abad Avenue, Dental School, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3882 9664
Email
EsmaeilzadehF991@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Esmaeilzadeh
Position
Resident of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil Abad Avenue, Dental School, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3882 9664
Email
EsmaeilzadehF991@mums.ac.ir

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
Comparison of the effects of audio-visual and in-person oral health education on the plaque index, awareness and performance of 9‒11-year-old children
When the data will become available and for how long
starting in 2023
To whom data/document is available
for everyone
Under which criteria data/document could be used
There is no specific item
From where data/document is obtainable
EsmaeilzadehF991@mums.ac.iraf
What processes are involved for a request to access data/document
As soon as they send and ask for
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