Evaluation of effectiveness of smartphone reminder application on oral hygiene compliance in patients with fixed orthodontic appliance: a randomized clinical trial
Determining the Effect of Using the Smartphone's Reminder App in Patients' Oral hygiene compliance with Orthodontics' fixed appliances
Design
In this study, 120 patients in two groups of control and intervention during a 3-month period will be studied. For blindness In this study, a clinician who measures the plaque index and gingival index of patients will not be aware of the presence of each patient in the control or intervention group.
Settings and conduct
Participants in this study will be 120 orthodontic patients between the ages of 25 and 15 years old whom referred to Hamadan Dental university and Dental Clinic. Patients will be examined during the three month period, and the initial examination will begin after signing of the testimonial by the patients or their parents . Patients' plaque index and gingival index will measured in baseline (T0) after 4 weeks (T1), 8 weeks (T2) and after12 weeks (T3). at the begining of the study, the Brushdj application is given to the intervention group. In this study, the clinicinian that measures the patients' plaque and gingival index will be blind.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1-girls and boys between 15-25 years old
2-patients that have their orthodontic appliances at least 12 weeks after starting the study
3-do not remove their appliance before finishing the study
4-do not have mental and physical disability
5-do not have enamel or dentin dysplasia or craniofacial abnormalities
6-patients smart phone with android>=4.0.3 or IOS>=9
exclusion criteria:
1-Patients who use drugs that are effective on the plaque accumulation such as antibiotics or antibacterial mouth rinses.
2- Individuals with any type of mental disorder whom has been diagnosed by psychiatrist .
Intervention groups
control and intervention group
Main outcome variables
Improvement of oral hygiene compliance in fixed orthodontic ptients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190106042253N1
Registration date:2019-02-03, 1397/11/14
Registration timing:prospective
Last update:2019-02-03, 1397/11/14
Update count:0
Registration date
2019-02-03, 1397/11/14
Registrant information
Name
Homa Farhadifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3835 4250
Email address
homa.far1989@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of smartphone reminder application on oral hygiene compliance in patients with fixed orthodontic appliance: a randomized clinical trial
Public title
Evaluation of effectiveness of smartphone application on oral hygiene in orthodontic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
girls and boys between 16-20 years old
patients that have their orthodontic appliances at least 12 weeks after starting the study
do not remove their appliance before finishing the study
do not have mental and physical disability
do not have enamel or dentin dysplasia or craniofacial abnormalities
patients smart phone with android>=4.0.3 or IOS>=9
Exclusion criteria:
1-Patients who use drugs that are effective on the plaque accumulation such as antibiotics or antibacterial mouth rinses.
2- Individuals with any type of mental disorder whom has been diagnosed by psychiatrist .
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with blocking
Blinding (investigator's opinion)
Single blinded
Blinding description
for blinding in this study, the clinician that evaluating plaque and gingival index dose not know that patient is in control or study group and patient dose not speak about his or her group with each other or with clinician
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan university of medical sciences
Street address
Shahid fahmide avenue
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.UMSHA.REC.1397.725
Health conditions studied
1
Description of health condition studied
oral hygiene compliance in fixed orthodontic patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
plaque index
Timepoint
in the baseline(before intervention,4,8 and 12 weeks after beginning of the study
Method of measurement
dental plaque disclosing agents
2
Description
gingival index
Timepoint
in the baseline(before intervention,4,8 and 12 weeks after beginning of the study
Method of measurement
periodontal prob
Secondary outcomes
1
Description
Frequency of brushing per day
Timepoint
from the beginning of intervention till 90 days later
Method of measurement
questionnaire
2
Description
brushing duration per day
Timepoint
from the beginning of intervention till 90 days later
Method of measurement
questionnaire
Intervention groups
1
Description
Control group: Individuals who are in the control group are provided with educational brochures on how to brush correctly. They also complete the form for 3 months, which includes information on the number and duration of brushing and the frequency of use of mouthwashes.
Category
Behavior
2
Description
Intervention group: Individuals in this group receive the Brushdj app in addition to the brochures and the form that the control group also receive. These people use reminders of the app to not forget the brushing time. Also, the 2-minute timer of this app is used to ensure that the brush is used for a long time.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty of Hamadan university
Full name of responsible person
Homa Farhadifard
Street address
Fahmide avenue
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3838 1059
Email
Homa.far1989@gmail.com
2
Recruitment center
Name of recruitment center
Hamadan university dental clinic
Full name of responsible person
Homa farhadifard
Street address
Felestin squar
City
Hamadan
Province
Hamadan
Postal code
65176-59114
Phone
+98 81 3423 8989
Email
Homa.far1989@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Fahmide avenue
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
S_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Homa Farhadifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fahmide Blvd.
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3835 4250
Fax
Email
homa.far1989@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Homa Farhadifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fahmide Blvd.
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3835 4250
Fax
Email
homa.far1989@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Homa Farhadifard
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
dental faculty of Hamadan,shahid fahmide street
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3838 1059
Email
homa.far1989@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected data would be shared without patients name or identification data
When the data will become available and for how long
starting in 2022
To whom data/document is available
Academic institution
Under which criteria data/document could be used
The data can be used in larger, multi center studies
From where data/document is obtainable
Researchers can assess data by emailing at homa.far1989@gmail.com
What processes are involved for a request to access data/document
After emailing the request for data, the data would be sent in 1 week to the researcher.