This study aimed to assess the effect of weekly text message reminders to parents or legal guardians of children under removable orthodontic treatment on their oral hygiene.
Design
In this 2-arm parallel randomized controlled trial, 50 participants were randomly allocated to two groups. Randomization was done with Minimization method by Minim soft ware
Settings and conduct
This study was done at Department of Orthodontic, School of Dentistry, Shiraz Branch, Azad University. In the first phase (T1), message reminders group received video and text messages containing information about the significance of oral hygiene twice a week for 4 weeks. In the second phase (T2) and third phase (T3), patients received reminder messages once a week for 2 months and once a week for 3 months, respectively. Control group received no message. Plaque index and gingival index were recorded at baseline (T0) and one (T1), three (T2) and six (T3) months after the first day of treatment by the same blinded examiner who did not have any information about participant’s division in the two groups.
Participants/Inclusion and exclusion criteria
8-12 years old children whose treatment plan included the use of a removable orthodontic appliance made of auto-polymerizing acrylic resin with a midline screw and had a minimum treatment duration of six months were selected in this study.
Patients who did not have daily access to Internet by their own smartphone or their parent , or had specific nutritional regimens, systemic diseases, syndromic anomalies such as cleft lip or palate and physical or mental disability were excluded.
Intervention groups
Patients were divided randomly into two groups of messaging and control. The patients in messaging group received text messages and videos as oral hygiene reminder while the control group did not receive any message.
Main outcome variables
Plaque and Gingival index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041092N2
Registration date:2020-07-25, 1399/05/04
Registration timing:retrospective
Last update:2020-07-25, 1399/05/04
Update count:0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Tahereh Baherimoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3649 1516
Email address
t_baheri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-20, 1398/01/31
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
2019-04-20, 1398/01/31
Actual recruitment end date
2019-07-22, 1398/04/31
Trial completion date
2020-02-11, 1398/11/22
Scientific title
Effect of Text Message Reminders on Oral Hygiene Promotion During Removable Orthodontic Treatment
Public title
Effect of Reminders on Oral Hygiene Promotion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being orthodontic patients for 6 months at least
Having removable orthodontic appliance made of auto-polymerizing acrylic resin with a midline screw
Exclusion criteria:
No daily access to Internet by smartphone or parents were not at home at the time of sending text messages due to their occupational schedule
Specific nutritional regimens
Systemic diseases
Syndromic anomalies such as cleft lip or palate and physical or mental disability.
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomized according to the minimization method proposed by Pandis. Minimization is a method of randomization used to ensure the balance of important prognostic factors among the groups and does not have the disadvantages of other randomization methods. List of randomization was not prepared in this method before the beginning of study; instead, it was prepared in the process of selection of participants. It is a dynamic method of randomization.
In the Minimization method, the first participant randomly entered into one of the groups and the next participant is entered into a group that has a lower predetermined factor in that group.
for example, if the first participant, who is an 8-year-old boy, joins the intervention group, the second participant who is a 10-year-old boy, will enter the to control group, by this way balance can be obtained in one of the predetermined factor "the sexuality" at least.
Minimization can be easily performed using software (Minim). However, the important point before using this software is to determine the important prognostic factors between groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
1. Examiner clinician
2.Person performed the data entry
3. Statistician
were unaware of patients group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kazerun Branch, Islamic Azad University, Iran.
Street address
5 km of Kazerun-Bushehr road
City
Kazerun
Province
Fars
Postal code
7319846451
Approval date
2020-06-19, 1399/03/30
Ethics committee reference number
IR.IAU.KAU.REC.1399.008
Health conditions studied
1
Description of health condition studied
The normal gingiva may range in color from light coral pink to heavily pigmented. It is normally stippled in appearance (resembling an orange peel). The makeup of the gingival tissue varies according to its location and function. There are two types of gingiva and several important anatomic regions.Free gingiva – This tissue is not attached and forms a collar around the tooth. The trough around the tooth is called the sulcus and its depth is normally 1-3 mm. It is lined with sulcular epithelium and attached to the tooth at its base by the epithelial attachment.Gingival margin – The border region of the gingiva that touches the tooth.Interdental papillae – The region of gingival tissue that fills the space between adjacent teeth. In a healthy mouth this is usually knife-edged and fills the interdental space.Muco-gingival junction – The scalloped line that divides the attached gingiva from the alveolar mucosa.
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Gingival inflammation
Timepoint
After one, three, and six month
Method of measurement
By using silness loe index
2
Description
Periodontal pocket depth
Timepoint
After one, three, and six month
Method of measurement
By using periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first phase (T1), the messaging group received video and text messages containing information about the significance of oral hygiene twice a week for 4 weeks. Time of sending the text messages was determined such that both the parents and patients were at home. The time interval between lunch and dinner was often chosen for most patients. For the rest of the patients, a convenient time was arranged following discussion with the parents. In the second phase (T2), patients received a message reminder for oral hygiene and educational videos once a week for 2 months. In the third phase (T3), message reminders were sent to the messaging group once a week for 3 months. Plaque index (PI), gingival index (GI) were recorded at baseline (T0) and one (T1), three (T2) and six (T3) months after the first day of treatment by the same blinded examiner who did not have any information about participant’s division in the two groups.
Category
Rehabilitation
2
Description
Control group: They received no video and text messages containing information about the significance of oral hygiene during study. Plaque index (PI), gingival index (GI) were recorded at baseline (T0) and one (T1), three (T2) and six (T3) months after the first day of treatment by the same blinded examiner who did not have any information about participant’s division in the two groups.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Branch, Islamic Azad University
Full name of responsible person
Tahereh Baheri Moghadam
Street address
Ghaani Street, Azad University
City
Shiraz
Province
Fars
Postal code
7184735716
Phone
+98 71 3830 8200
Email
T_baheri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz Branch, Islamic Azad University
Full name of responsible person
Tahereh Baheri Moghadam
Street address
Ghaani Street, 14h Alley, Dental School.
City
Shiraz
Province
Fars
Postal code
7184735716
Phone
+98 71 3830 8200
Email
T_baheri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Branch, Islamic Azad University
Proportion provided by this source
50
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
Shiraz Branch, Islamic Azad Univeristy
Full name of responsible person
Tahereh Baheri Moghadam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontics
Street address
Ghaani Street, 14h Alley, Dental School
City
Shiraz
Province
Fars
Postal code
7184735716
Phone
+98 71 3830 8200
Fax
Email
T_baheri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Branch, Islamic Azad University
Full name of responsible person
Navid Naseri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontics
Street address
Staarkhan Street, 11 th Alley
City
Shiraz
Province
Fars
Postal code
7184735716
Phone
+98 71 3649 1516
Email
NavidNaseri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Branch, Islamic Azad University
Full name of responsible person
Navid Naseri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Arthodontics
Street address
Staarkhan Street, 11th Alley
City
Shiraz
Province
Fars
Postal code
7184735716
Phone
+98 71 3649 1516
Email
Navidnaseri@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effect Message Reminders on Oral Hygiene Promotion During Removable Orthodontic Treatment
When the data will become available and for how long
Data is available after the article is published
To whom data/document is available
For all those who have an official request.
Under which criteria data/document could be used
None of the patients' names should be mentioned anywhere
From where data/document is obtainable
It is available through the زcorresponding for information.
What processes are involved for a request to access data/document
Official request from the University's Vice Chancellor for Research