Comparing the effectiveness of oral and dental health education by video and face-to-face methods on the level of oral and dental health indicators and child cooperation in 6-12-year-old students with autism spectrum disorders
This study was aimed to compare the effectiveness of oral and dental health education by video and face-to-face methods on plaque index, gum index, child cooperation and habits related to oral and dental hygiene in 6-12-year-old students with autism spectrum disorders.
Design
Randomized, with a parallel group design of 65 patients
Settings and conduct
The current study is an interventional and semi-experimental study that will be conducted in Mashhad primary schools. Students of each group will be selected from a different school.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 6-12 years
Patients in the mild to moderate stage of autism spectrum disorders
Signing the informed consent form
Exclusion criteria:
- Existence of other physical or developmental or mental disabilities and inability to cooperate with the patient
- The unwillingness of the child or his parents to participate or continue attending the study
Intervention groups
After matching the intervening variables randomly, patients (n=65) will be divided into two groups, including the video training group and the face-to-face training group.
Main outcome variables
Decay index; index plate; cooperation index; gingival index; The frequency of using a toothbrush
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231231060582N1
Registration date:2024-01-26, 1402/11/06
Registration timing:prospective
Last update:2024-01-26, 1402/11/06
Update count:0
Registration date
2024-01-26, 1402/11/06
Registrant information
Name
Sahar Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5696
Email address
sahar-ebrahimi98@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of oral and dental health education by video and face-to-face methods on the level of oral and dental health indicators and child cooperation in 6-12-year-old students with autism spectrum disorders
Public title
Effects of health education on oral and dental health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 6-12 years old
Patients on mild to moderate stage of autism spectrum disorders
Signing consent form by parents
Exclusion criteria:
The existence of other physical or developmental or mental disabilities and inability to cooperate with the patient
The unwillingness of the child or her/his parents to participate or continue the study
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2023-10-09, 1402/07/17
Ethics committee reference number
IR.BUMS.REC.1402.294
Health conditions studied
1
Description of health condition studied
autism spectrum disorder
ICD-10 code
F84.0
ICD-10 code description
autism spectrum disorder, oral health, education
Primary outcomes
1
Description
Tooth decay
Timepoint
At the beginning of the study (before the start of the intervention) and after the intervention
Method of measurement
Based on dmft index
2
Description
Children's cooperation index
Timepoint
At the beginning of the study (before the start of the intervention) and after the intervention
Method of measurement
Based on the Frankel Index
3
Description
The frequency of using a toothbrush
Timepoint
At the beginning of the study (before the start of the intervention) and after the intervention
Method of measurement
Based on the number of times they brush their teeth
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In order to carry out the intervention in the video intervention group, an educational video about self-care skills will be delivered to the patient. The content of educational videos will be designed under the supervision and guidance of a group of experts according to the objectives of the study and will be provided to the instructors of this group. Educators will be asked to play video content for children three times a week according to the designed educational program and make sure that the child sees the video content. Also, the child will be asked to repeat the movements step by step along with the video. The families will be asked to install the reminder educational poster in front of the child during the implementation of oral and dental care techniques at home and to monitor the requirement every night while brushing teeth at home according to the principles stated in the pamphlet.
Category
Behavior
2
Description
Intervention group 2: In the face-to-face training group, before starting the study, the instructors will be taught the correct way of brushing teeth in certain children based on valid references by the researcher. children will receive oral and dental self-care educations three times a week according to the designed educational program. In this group, along with the teacher, children will learn brushing movements in front of the mirror and repeat it step by step. The same educational poster as the other group will be provided to this group as well. Also, like the video training group, parents should monitor and accompany the child during all stages of oral and dental self-care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand University of medical sciences
Full name of responsible person
Sahar Ebrahimi
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5696
Email
Sahar_ebrahimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Khademi
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5696
Email
Mehr.kh6688@yahoo.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
Birjand University of Medical Sciences
Full name of responsible person
Mehrnaz Khademi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5696
Email
mehr.kh6688@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mehrnaz Khademi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5696
Email
mehr.kh6688@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sahar Ebrahimi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5696
Email
sahar_ebrahimi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Comparing the effectiveness of oral and dental health education by video and face-to-face methods on the level of oral and dental health indicators and child cooperation in 6-12-year-old students with autism spectrum disorders
When the data will become available and for how long
Not decided yet
To whom data/document is available
People working in academic institutions and parents of children with autism
Under which criteria data/document could be used
Not decided yet
From where data/document is obtainable
Responsible persons:
Sahar Ebrahimi sahar_ebrahimi@yahoo.com
Dr. Mehrnaz Khademi mehr.kh6688@yahoo.com
What processes are involved for a request to access data/document
The applicant must send his request for information or data to the email address of the respondents within 6 months after completing and analyzing the results. Requests will be processed after the results are published in scientific articles.