Investigating the effect of a toothbrush reminder application and a health education video on the oral health of patients undergoing orthodontic treatment.
Determining the effect of a toothbrush reminder program combined with a hygiene education video on the oral health of patients that are having orthodontic treatment.
Design
60 patients are randomly selected and divided into two groups. One group receives an intervention and the control group receives no intervention.
Settings and conduct
In this study, 30 patients with orthodontic treatment will be randomly divided into two groups: an intervention group and a control group. The intervention group will receive a toothbrush reminder app and the control group will only receive a hygiene education video.
Participants/Inclusion and exclusion criteria
The conditions for entering the study are having dental plaque, having a fixed or removable orthodontic appliance, having a smart phone, and being a member of the application to join the virtual network group of this study. Also, not smoking and not having systemic diseases or congenital diseases.
The criteria for exiting the study are unwillingness to cooperate.
Intervention groups
For the experimental group, an app will be used to remind patients of their brushing schedule. This app, along with a training video, will be provided to the patient to ensure the patient uses the app and to answer patients' questions about how to control hygiene. All selected patients in the experimental group will be members of a group in the virtual space and will daily report their use of the app and their questions. If the patient does not report, follow-up will be done. Only a training video will be provided to the control group.
Main outcome variables
The results obtained can be used practically. Furthermore, this research will determine whether existing applications for improving human health can improve oral hygiene in this study or are merely commercial and research-oriented.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241123063809N1
Registration date:2024-12-25, 1403/10/05
Registration timing:prospective
Last update:2024-12-25, 1403/10/05
Update count:0
Registration date
2024-12-25, 1403/10/05
Registrant information
Name
Samira Behrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3332 1026
Email address
samirabehrad84@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-03, 1403/11/15
Expected recruitment end date
2025-02-08, 1403/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a toothbrush reminder application and a health education video on the oral health of patients undergoing orthodontic treatment.
Public title
Investigating the effect of a toothbrush reminder application and a health education video on the oral health of patients undergoing orthodontic treatment.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 15-40
Having smart phone
Using orthodontic appliance fix or removable
Having messenger application
Exclusion criteria:
Not using cigarettes
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
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 Semnan University of Medical Sciences and health services
Street address
Semnan, 17 Shahrivar Blvd., Dental Faculty of Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35187-94431
Approval date
2024-10-14, 1403/07/23
Ethics committee reference number
IR.SEMUMS.REC.1403.139
Health conditions studied
1
Description of health condition studied
oral health situation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dental plaque burden
Timepoint
Dental plaque index at baseline and 3 months post-intervention
Method of measurement
Dental explorer probe and Plaque disclosing tablet
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Developing a reminder app for brushing and educational videos on oral hygiene for orthodontic patients at Semnan Dental School.
Category
Prevention
2
Description
Control group: Disseminating educational videos regarding oral hygiene protocols.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan Dental School
Full name of responsible person
Samira Behrad
Street address
Semnan, 17 Shahrivar Blvd., Dental Faculty of Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35187-94431
Phone
+98 23 3332 4700
Email
samirabehrad84@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Sadat Afraz
Street address
Semnan, 17 Shahrivar Blvd., Dental Faculty of Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35187-94431
Phone
+98 23 3332 4700
Email
dent@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Amirreza Damanabi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 34, 10th West Street, Gohardasht, Karaj, Iran
City
Semnan
Province
Semnan
Postal code
3148957995
Phone
+98 26 3448 3831
Email
amirreza.damanabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Samira Behrad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pathology
Street address
Semnan, 17 Shahrivar Blvd., Dental Faculty of Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35187-94431
Phone
+98 23 3332 1026
Fax
Email
Samirabehrad84@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Amirreza Damanabi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 34, 10th West Street, Gohardasht, Karaj, Iran
City
Semnan
Province
Semnan
Postal code
3148957995
Phone
+98 26 3448 3831
Email
amirreza.damanabi@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
All data can be potentially shared after individuals have been de-identified.
When the data will become available and for how long
The data will be accessible for a period of one month following the publication of the results.
To whom data/document is available
The data will be made available to all individuals working in the field of dentistry.
Under which criteria data/document could be used
Individuals with expertise in both statistics and dentistry will be authorized to submit requests for access to the data or documentation.
From where data/document is obtainable
The documents will be received via email at the samirabehrad84@gmail.com address.
What processes are involved for a request to access data/document
The data will be provided to the requester after the request has been evaluated and the individual's identity and qualifications have been verified.