Protocol summary

Study aim
evaluating the effect of a smartphone application on oral health indices and literacy of school-aged adolescents in through a brief intervention in Ahvaz
Design
community based, parallel group, double blind, randomised controlled trial
Settings and conduct
health education for students, middle schools, clinical examinations and oral health instructions and questionnaire fulfillment students and data analyzer are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. individuals must be completely satisfied to participate in the study. 2. individuals must be 12-15 years old. 3. individuals must be have access to a smartphone. 4. individuals must be in permanent dentition. Exclusion criteria: 1. no presence of any diagnosed disease 2. unable to follow-up 3. relocating to another school 4. any disease that affects the study 5. orthodontics treatment
Intervention groups
randomly selecting to groups of students, face to face education of oral health for control group, smartphone-application-based education of oral health for intervention group
Main outcome variables
oral health observance; oral health literacy elevation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191016045128N1
Registration date: 2019-10-29, 1398/08/07
Registration timing: prospective

Last update: 2019-10-29, 1398/08/07
Update count: 0
Registration date
2019-10-29, 1398/08/07
Registrant information
Name
Samaneh Khanehmasjedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 9516
Email address
khanehmasjedi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluating the effect of a smartphone application on oral health indices and literacy of school-aged adolescents in Ahvaz
Public title
evaluating the effect of a smartphone application on oral health in school-aged adolescents in Ahvaz
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
individuals must be completely satisfied to participate in the study. individuals must be 12-15 years old. individuals must be have access to a smartphone. individuals must be in permanent dentition.
Exclusion criteria:
presence of any diagnosed disease unable to follow-up relocating to another school any disease that affects the study orthodontics treatment
Age
From 12 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
method of randomization in this study is block. unit of randomization is individual. sealed envelope is the tool used in randomization. the random sequence was built by throwing coins.
Blinding (investigator's opinion)
Double blinded
Blinding description
in this study the participants, data analyzer and the main investigator are blinded. outcome collector and assessor is not blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Approval date
2019-05-05, 1398/02/15
Ethics committee reference number
IR.AJUMS.REC.1398.116

Health conditions studied

1

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

Primary outcomes

1

Description
The extent of people's health observance
Timepoint
4 months after intervention
Method of measurement
oral health literacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: a group of students that receive an educational smartphone application made by researcher, according to referenced textbooks.
Category
Prevention

2

Description
Control group: a group of students which receive the gold standard method of oral health education; face to face education.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
kowthar middle school
Full name of responsible person
Samaneh Khanehmasjedi
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Email
khanehmasjedi.s@ajums.ac.ir

2

Recruitment center
Name of recruitment center
setayesh middle school
Full name of responsible person
Samaneh Khanehmasjedi
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Email
khanehmasjedi.s@ajums.ac.ir

3

Recruitment center
Name of recruitment center
middle school
Full name of responsible person
Samaneh Khanehmasjedi
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Email
khanehmasjedi.s@ajums.ac.ir

4

Recruitment center
Name of recruitment center
shahid abbaspoor middle school
Full name of responsible person
Samaneh Khanehmasjedi
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Email
khanehmasjedi.s@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Vice-Chancellor for Research and Technology Development, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
khanehmasjedi.s@ajums.ac.ir
Grant name
Research deputy of Ahvaz University of Medical Science
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Khanehmasjedi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Email
khnehmasjedi.s@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Bassir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Email
basir-l@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Khanehmasjedi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Unit 2, No 65, West Mihan street, Chamran avenue, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155814885
Phone
+98 61 3338 9516
Email
khnehmasjedi.s@ajums.ac.ir

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Loading...