The effect of active reminder of oral health education during fixed orthodontic treatment on plaque index and bleeding on probing
Design
Analytical study of clinical trial with control group.double bilnd with parallel groups on 40 patients.The table of random numbers will be used for randomization.
Settings and conduct
Patient applying for fixed orthodontic treatment who will refer to dental clinic affiliated to the Shahid Sadoughi University of Medical Scinces, Yazd, will be randomly assigned to two groups without knowing about the groupnig.The first group just receives the hygiene education at the beginning of the treatment .The intervention group in addition primary hygiene education, will receives the reminder text messages .At the begining ,the fourth and the twelfth weeks after the start of the study ,Plaque index and the bleeding on probing will be measured .The examiner and the analyzor dont know the groupng of the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age between 12-25 years old
permanent teeth system
without trauma history
accss to mobile phone
needing to upper jaw fixed orthodontic treatment
Exclusion criteria:
systemic disease
antibiotic therapy
periodontal disease
smoking
electric tooth brush
Intervention groups
Patient will be divided into two groups.The first group will be considered as control and will only receive the same initial training before starting the treatment.In addition to the initial training the second group will receive oral hygiene training daily in first month and twice a week in the second and third months.
Main outcome variables
Plaque index
Bleeding on probing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230304057614N1
Registration date:2023-05-03, 1402/02/13
Registration timing:prospective
Last update:2023-05-03, 1402/02/13
Update count:0
Registration date
2023-05-03, 1402/02/13
Registrant information
Name
Neda Joshan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3621 2222
Email address
n.joshan@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of active reminder of oral health education during fixed orthodontic treatment on plaque index and bleeding on probing
Public title
The effect of active reminder of health education on hygiene indexes during fixed orthodontic treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 12-25
Permanent teeth system
Without trauma history
Available phone
Needing to upper jaw fixed orthodontic treatment
Exclusion criteria:
Systemic disease
Smoking
Antibiotic therapy
Electric tooth brush
Age
From 12 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple and the unit of randomization is the individual. Using the table of random numbers, patients will be randomly placed in two groups: the group without reminders and the group with reminders. Even numbers for the group without reminders and odd numbers for the group a reminder Random allocation is done by the researcher, and the clinical caregiver and the analyst are not aware of the allocation of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Random allocation is done by the researcher, and the clinical caregiver and the analyst are not aware of the allocation of patients. An impartial examiner who is a dental intern and does not know the grouping of the participants, collect the data and record the information.The analyzor does not know about the patient grouping too.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee in Biomedical Research
Street address
Block NO A-central headquarters of the ministry of health-Sima Iran Street-Quds
City
Tehran
Province
Tehran
Postal code
8915173160
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.SSU.REC.1399.015
Health conditions studied
1
Description of health condition studied
Plaque index and bleeding on probing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plaque index
Timepoint
First of syudy-fourth week from the beginning of the study-the twelfth week from the beginning of the study
Method of measurement
Observation by prob and dental mirror
2
Description
Bleeding on probing
Timepoint
First of syudy-fourth week from the beginning of the study-the twelfth week from the beginning of the study
Method of measurement
Observation by prob and dental mirror
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After oral health education in the begining of the treatment by dentist, active reminding of oral health education by SMS in the beginning of study then daily in first month after that two times a week in second and third months will be sent .The content of the SMS is a reminder to do oral and dental hygiene by using a manual toothbrush and dental floss in accordance with standard prophylactic principle.
Category
N/A
2
Description
Intervention group: this group receives oral and dental hygiene recommendations from the dentist at the beginning of the treatment and they do not receive reminder messages
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
dental clinic affiliated to Shahid Sadoughi University of Medical Sciences .YAZD
Full name of responsible person
Neda Joshan
Street address
Imam Reza Squre-dahe Fajr blvd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 6975
Fax
+98 35 3625 6975
Email
Neda.joshan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Neda Joshan
Street address
Imam Reza Squre-Dahe Fajr blvd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 2222
Fax
+98 35 3621 2222
Email
Neda.joshan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
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
Yazd University of Medical Sciences
Full name of responsible person
Reyhanehalsadat Jafari
Position
Postgraduated Student, Department Of Oral and Maxillifacial Radiology School of Dentistry, Shahid Sa
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Imam Reza Squre -Dahe Fajr blvd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 2222
Fax
+98 35 3621 2222
Email
jafari_rs@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reyhanehalsadat Jafari
Position
Postgraduated Student, Department of Oral and Maxillofacial Radiology School of Dentistry, Shahid Sa
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Imam Reza Squre - Dahe Fajr blvd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 2222
Fax
+98 35 3621 2222
Email
jafari_rs@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reyhanehalsadat Jafari
Position
Postgraduated Student, Department of Oral and Maxillofacial Radiology School of Dentistry, Shahid Sa
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Imam Reza Square_Dahe Fajr blvd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 2222
Fax
Email
jafari_rs@yahoo.com
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