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Effectiveness of a mobile application-based intervention on knowledge of oral care and oral health behavior of disadvantaged 12-year-old adolescents: A community-based trial

Protocol summary

Study aim
Effectiveness of a mobile application-based intervention on knowledge of oral care and oral health behavior of disadvantaged 12-year-old adolescents
Design
Field trial, with single groups, phase 2 on 312 patients
Settings and conduct
Determining the sample size is done using Morgan's table and Cochran's formula among girls' and boys' schools in the less privileged areas of Torbetjam city. Based on this formula, 312 12-year-old students enter the study in the sixth grade of these schools In order to carry out this study, the oral examination of the students is done first, and the dental status and oral hygiene of the students are measured using DMFT, PI (Plaque Index, Quiengly-Hein), (Bleeding On Probing) BOP, and (Modified Gingival Index). MGI is checked and recorded by the student who is calibrated for this purpose, then a pretest is conducted in person and during it, the students are asked about health behaviors and eating habits (frequency of eating foods containing added sugar) and the application Mobile phone, whose validity and reliability was previously conducted in the study "Design and Validation of Remote Oral Health Screening Application" is introduced to them. In this application, oral care training is given to them. At the end of the study, after 6 months, the students are examined again based on the same indicators and the post test is done in person.
Participants/Inclusion and exclusion criteria
6th grade elementary school students in low-income schools in Torbet Jam-having a mobile phone
Intervention groups
Teaching oral and dental health care through a mobile application
Main outcome variables
Measurable outcome: average correct answers of students to pre-test and post-test questions, DMFT and care index (F/DMF), restoration index (F/D), treatment index*100 (DMF/M+F), PI and MGI before and after from intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230817059173N1
Registration date: 2023-09-09, 1402/06/18
Registration timing: prospective

Last update: 2023-09-09, 1402/06/18
Update count: 0
Registration date
2023-09-09, 1402/06/18
Registrant information
Name
shima tarahomi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5254 6279
Email address
sh.tarahomi91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of a mobile application-based intervention on knowledge of oral care and oral health behavior of disadvantaged 12-year-old adolescents: A community-based trial
Public title
Effectiveness of a mobile application-based intervention on knowledge of oral care and oral health behavior of disadvantaged 12-year-old adolescents: A community-based trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- 6th grade primary school student in the underprivileged schools of Torbat Jam 2- Having a mobile phone
Exclusion criteria:
Age
From 12 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 312
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Musa-bin-Jafar 14
City
Torbat-jam
Province
Razavi Khorasan
Postal code
9571975437
Approval date
2023-04-09, 1402/01/20
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1401.149

Health conditions studied

1

Description of health condition studied
dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries

2

Description of health condition studied
gingivitis and periodontal disease
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases

Primary outcomes

1

Description
Mean difference of correct answers in pre-test and post-test
Timepoint
Six months
Method of measurement
Forms

2

Description
Care Index (F/DMF)
Timepoint
Six months
Method of measurement
Oral examination

3

Description
Restorative Index (F/D)
Timepoint
Six months
Method of measurement
Oral examination

4

Description
Treatment Index (F+M/DMF)
Timepoint
Six months
Method of measurement
Oral examination

5

Description
Plaque index
Timepoint
Six months
Method of measurement
Oral examination

6

Description
Modified Gingival Index
Timepoint
Six months
Method of measurement
Oral examination

7

Description
Bleeding On Probing (BOP)
Timepoint
Six months
Method of measurement
Oral examination

Secondary outcomes

1

Description
Diet modification
Timepoint
Six months
Method of measurement
Forms

2

Description
Dental appointment
Timepoint
Six months
Method of measurement
Post-test Forms

3

Description
Oral Hygiene instruction
Timepoint
Six months
Method of measurement
Observation

Intervention groups

1

Description
Intervention group: 1- In the pre-exam, a form containing questions about oral hygiene habits and the use of snacks will be completed by students. 2- The method of brushing and flossing their teeth is observed. 3- Oral and dental care is explained by the researcher according to the guidelines for the prevention of caries and periodontal disease. 4- The students undergo a clinical oral examination by the researcher. After 6 months, 1- students complete the post-exam form 2- their brushing and flossing methods are observed. 3- Students are subjected to oral clinical examination by the researcher.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Torbet Jam primary schools
Full name of responsible person
shima tarahomi
Street address
Musa Bin Jafar
City
torbat jam
Province
Razavi Khorasan
Postal code
9571975437
Phone
+98 51 5254 6279
Email
sh.tarahomi91@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Amir Moin Taqavi
Street address
Vakil Abad Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
13944 91388
Phone
+98 51 3841 2081
Email
p.relations@mums.ac.ir
Web page address
https://mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Shima Tarahomi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
14 Musa bin Jafar, No. 16
City
torbat jam
Province
Razavi Khorasan
Postal code
9571977887
Phone
+98 51 5254 6279
Fax
Email
sh.tarahomi91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Tarahomi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
14 Musa bin Jafar, No. 16
City
torbat jam
Province
Razavi Khorasan
Postal code
9571977887
Phone
+98 51 5254 6279
Fax
Email
sh.tarahomi91@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
shima tarahomi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Musa bin Jafar 14, No. 16
City
torbat jam
Province
Razavi Khorasan
Postal code
9571977887
Phone
+98 51 5254 6279
Email
sh.tarahomi91@gmail.com

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
The effectiveness of an intervention based on a mobile phone program on oral health behavior and oral care awareness of 12-year-old adolescents
When the data will become available and for how long
After printing the results
To whom data/document is available
Working researchers
Under which criteria data/document could be used
Under the research conditions, the use of analyzes on the delivered data is allowed, the use of documentation is allowed
From where data/document is obtainable
Postal address, e-mail, application and phone numbers of Shima Tarhami and Mrs. Dr. Hadie Totoni
What processes are involved for a request to access data/document
After making a request through postal address, email, application and phone numbers, they will receive the data within three working days
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