To compare the effectiveness of the health education by assistant with social media on oral hygiene in fixed orthodontic patients
Design
This randomized and single-blind clinical trial with parallel and control groups will be conducted on 60 patients who will be randomly selected using the blocks.
Settings and conduct
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive health education by social media and control by assistant for oral hygiene. The person responsible for data collection is blind to group allocation and the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No having tooth decay; no having soft tissue diseases; having fixed orthodontic appliances; having cell phone for install applications and learning program.
Exclusion criteria: Having systemic diseases.
Intervention groups
The intervention group will receive health education via social media that is available to the patient (how to brush their teeth and using orthodontic flossers). The control group will receive health education via assistant on the dental model (how to brush their teeth and using orthodontic flossers).
Main outcome variables
Evaluation and comparison of the orthodontic plaque index and gingival index (discolored gums, inflammation and change in texture in the gums) in control and intervention groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200609047705N2
Registration date:2021-07-13, 1400/04/22
Registration timing:prospective
Last update:2021-07-13, 1400/04/22
Update count:0
Registration date
2021-07-13, 1400/04/22
Registrant information
Name
Homan Shafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 2300
Email address
shafaeeh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of the health education by assistant with social media on oral hygiene in fixed orthodontic patients
Public title
The effectiveness of health education on oral hygiene in fixed orthodontic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No having tooth decay
No having soft tissue diseases
Having fixed orthodontic appliances
Having cell phone for install applications and learning program
Exclusion criteria:
Having systemic diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of block randomization. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Random allocation software software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive health education by social media and control by assistant for oral hygiene. The person responsible for data collection is blind to group allocation and the type of intervention.
Placebo
Not used
Assignment
Parallel
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
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2020-12-16, 1399/09/26
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.118
Health conditions studied
1
Description of health condition studied
Orthodontic
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Orthodontic plaque index
Timepoint
Before and one month after intervention
Method of measurement
Staining the teeth or surfaces with a plaque-disclosing solution such as erythrosine
2
Description
Gingival index (discolored gums, inflammation and change in texture in the gums)
Timepoint
Before and one month after intervention
Method of measurement
During the examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive health education via social media that is available to the patient (how to brush their teeth and using orthodontic flossers).
Category
Prevention
2
Description
Control group: The control group will receive health education via assistant on the dental model (how to brush their teeth and using orthodontic flossers).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Homan Shafaei
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
shafaeeh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@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
Homan Shafaei
Position
Orthodontic
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
shafaeeh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Homan Shafaei
Position
Orthodontic
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
shafaeeh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Homan Shafaei
Position
Orthodontic
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
shafaeeh@mums.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The research data obtained from the main outcomes of the study can be shared freely as 'open data'.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
From where data/document is obtainable
Homan Shafaei provides the data analysis to the applicants via email: shafaeeh@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can send emails to him and receive a response within a week.