Designing and evaluation of an oral hygiene educational intervention to improve the oral health of elementary students (aged 6-15yrs) with autism spectrum disorders
Determining and comparing oral hygiene status of elementary students (6-15yrs) with Autism based on simplified oral hygiene index between two intervention and comparison groups in autistic schools before and after intervention.
Design
quasi-experimental clinical trial, with two parallel intervention groups, Non randomized ,on 90 students
Settings and conduct
Informed Consent will be obtained from parents of 90students from 4 Tehran autistic schools. they will complete a questionnaire and students will be examined and OHI-S will be recorded. In 2schools, the intervention packages will be provided, in 2 others comparison package will be given. After one-month intervention, parents will answer the post-intervention questionnaire and OHI-S will be recorded. After 3months OHI-S will be recorded.
Participants/Inclusion and exclusion criteria
inclusion criteria:1-consent of parents 2-The student should be in the first to sixth grade of elementary school. 3- َAge of the student should be 6 to 15 years old. 4- Including only ASD Level1,2. 5-Family should have access to the WhatsApp.
Exclusion criteria:1- Participants with other disabilities. 2-participants
who are unable to cooperate.
Intervention groups
Intervention package:1-Teaching children how to brush their teeth with Fonnes technique through video modeling:2- Educational session for parents. 3-Installation of a poster of correct way of tooth brushing in bathroom at home. 4 - Educational session for teachers: to help peer working of students in class 5 - Reminder and motivation: twice a week
Comparison Package: 1- Social story of oral hygiene along with a pamphlet containing similar information in the face-to-face meeting held in the intervention group will be given to the parents. 2.A reminder message will be sent twice a week, similar to the intervention group. 3-Installation of a pictured poster
Main outcome variables
Oral hygiene status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200208046413N1
Registration date:2020-07-05, 1399/04/15
Registration timing:retrospective
Last update:2020-07-05, 1399/04/15
Update count:0
Registration date
2020-07-05, 1399/04/15
Registrant information
Name
Hediyeh Piraneh Haghighi Bonab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4175
Email address
h.piraneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-23, 1399/03/03
Expected recruitment end date
2020-06-02, 1399/03/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluation of an oral hygiene educational intervention to improve the oral health of elementary students (aged 6-15yrs) with autism spectrum disorders
Public title
Evaluation of an oral hygiene educational intervention to improve the oral health of elementary students with autism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of parents
The students should be at first to sixth grade of elementary school
Age of the student should be 6 to 15 years old
Including only ASD Level 1 and 2
Family should have access to the WhatsApp social network.
Exclusion criteria:
Participants with other disabilities.
participants who are unable to cooperate. (Because of stress, panic attacks, fainting history, etc.)
Age
From 6 years old to 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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 School of Dentistry- Tehran University of Medical Sciences
Street address
School of Dentistry of Tehran University of Medical Sciences, Adjacent to the Atomic Energy Organization, End of North Kargar S.t, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Approval date
2019-12-08, 1398/09/17
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1398.153
Health conditions studied
1
Description of health condition studied
Oral hygiene
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Oral hygiene status
Timepoint
before intervention, 30 days after the intervention and 3 Months later
Method of measurement
Simplified-Oral-Hygiene-Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1- Teaching children how to brush their teeth with Fonnes technique through video: A CD containing a short film that teaches children with ASD, method of brushing with fonnes technique in a simple and understandable way, is designed and distributed. In it, a 10-year-old child is brushing his teeth and every part of his mouth that he brushes a Voice describes it behind the scenes with simple sentences and slow speed. The video file is provided to the parents of the intervention group through the WhatsApp social network and they are asked to play it to their children every day. 2- Educational session for the parents of the students: In each of the schools with Previous coordination with the school principal we ask students' parents to attend a group meeting. Speech with slides by a researcher for 15 minutes with the content of importance, prevalence, etiology and control of oral diseases including gum disease, caries and ways to deal with it, including nutritional recommendations and plaque control will take place. The brushing tutorial video is also shown to the audience, and the Fonnes brushing technique is taught to parents to monitor their child's brushing at home. A illustrated poster is then given to parents on how to brush properly to install on the wall of their bathroom at home to help the child brush properly. Parents are also asked to introduce conditions of the examination day to their children one week before the next clinical examination, through the social story given to them in the pre-intervention stage. 3- Teacher training session: Teachers also are taught how to brush with Fonnes Technic. And they are asked to show their students how to brush twice a week with a three-dimensional toothbrush and mouth model, and then accompany them to brush with their friends in the school environment. 4- Reminding and motivating Twice a week: a reminder is sent to parents of children through the WhatsApp social network.
Category
Prevention
2
Description
Control group: 1- A written guide in the form of a pamphlet containing information similar to the face-to-face meeting held in the intervention group is presented to the parents. 2- The social story on the subject of brushing with Fonnes technique is given to the parents of this group and they are asked to work on this social story at home with their child. 3. A reminder message will be sent to them twice a week, similar to the intervention group through whats App social network.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besharat special school
Full name of responsible person
Fatemeh Mashhadi
Street address
No.6, Corner of 120 East St., 105 Tehranpars St. Khaghani CrossroadTehrane no St.
City
Tehran
Province
Tehran
Postal code
4447879034
Phone
+98 21 7794 0181
Fax
+98 21 7795 7432
Email
F_mashhadi@gmail.com
Web page address
http://www.besharat1374.blogfa.com/
2
Recruitment center
Name of recruitment center
Imam Jafar Sadegh special school
Full name of responsible person
Zahra Mazloomi
Street address
No.10, Taheri St. ,Sajadieh Town, Ayatollah Boroujerdi Blvd. East Shousha St.
No.4, Alley 44., Kalantari Square, Seyed Jamaluddin Asadabadi St.
City
Tehran
Province
Tehran
Postal code
4444127834
Phone
+98 21 8803 8549
Fax
+98 21 8803 8549
Email
Zeynab.chvsh45@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahraian
Street address
6th floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
4447689043
Phone
+98 21 8163 3698
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
45
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
2
Sponsor
Name of organization / entity
Dental caries prevention research center
Full name of responsible person
Dr. Amirreza Rokn
Street address
Research Institute of Dental Sciences, School of Dentistry , Quds St., Enqelab St.
City
Tehran
Province
Tehran
Postal code
4445678399
Phone
+98 21 6640 1132
Fax
+98 21 8898 6688
Email
info@dri.ir
Web page address
http://dri.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental caries prevention research center
Proportion provided by this source
55
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
Tehran University of Medical Sciences
Full name of responsible person
Hedieh Piraneh Haghighi Bonab
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
community oral health
Street address
School of Dentistry of Tehran University of Medical Sciences, End of North Kargar St.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 7279 4175
Fax
+98 21 7279 4175
Email
h.piraneh@yahoo.com
Web page address
http://dentistry.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hedieh Piraneh Haghighi Bonab
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
community oral health
Street address
School of Dentistry of Tehran University of Medical Sciences, End of North Kargar St.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 7279 4175
Fax
+98 21 7279 4175
Email
h.piraneh@yahoo.com
Web page address
http://dentistry.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hedieh Piraneh Haghighi Bonab
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
community oral health
Street address
School of Dentistry of Tehran University of Medical Sciences, End of North Kargar St.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 7279 4175
Fax
+98 21 7279 4175
Email
h.piraneh@yahoo.com
Web page address
http://dentistry.tums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period 3 to 6 months after publishing the results
To whom data/document is available
Researchers and people working in the field of education or industry can apply for data.
Under which criteria data/document could be used
Any statistical use and analysis is permitted for the purpose of promoting oral health in people with autism.
From where data/document is obtainable
See Dr. Hedyeh Piraneh Haghighi Bonab
Address: Department of Community Oral Health, Faculty of Dentistry of Tehran University of medical sciences, End of North kargar,Tehran, Iran.
Postal Code: 1439955991
Email: h.piraneh@yahoo.com
Mobile: 00989058873546
What processes are involved for a request to access data/document
The applicant can send his / her details and the organization in which he / she works and the exact details and purpose of his / her request via e-mail. Finally, the response will be done within a week.