Protocol summary

Study aim
The effect of SMS reminder after oral hygiene instruction on Plaque Index and oral health related quality of life(OHRQoL) in pregnant women of Isfahan
Design
This study is an interventional randomized controlled clinical trial. The sampling method is simple and the samples of this study are from people referring to comprehensive health centers that have midwifery and dentistry (such as Mohkamkar health center in Zeinabia) They are elected in Isfahan in 1400. A total of 60 samples will be collected and divided into two groups of 30 intervention and control with a computer application.
Settings and conduct
Comprehensive health centers such asMohkam karl Health Center in Zeinabiyeh
Participants/Inclusion and exclusion criteria
Inclusion criteria included: willingness to participate in the project, the second or third month of pregnancy, not using drugs that affect periodontal conditions, including anticonvulsants (phenytoin), immunosuppressive drugs (cyclosporine) and calcium channel blockers (Nifedipine), the ability to accurately understand the questions of the questionnaire, the ability to read and access the mobile phone. Exclusion criteria include: the person's decision not to continue the plan, smoking, systemic diseases, use of orthodontic applause and the inability of the person to maintain oral health (due to oral injury or physical disability)
Intervention groups
Pregnant women who receive a reminder text message on a weekly basis after a health examination and oral health instruction.
Main outcome variables
Plaque index- Oral health related quality of life(ohip-14 index)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211109053015N1
Registration date: 2021-11-29, 1400/09/08
Registration timing: registered_while_recruiting

Last update: 2021-11-29, 1400/09/08
Update count: 0
Registration date
2021-11-29, 1400/09/08
Registrant information
Name
Adel Tabesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 2968
Email address
adel.tabesh@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of SMS reminder after oral hygiene instruction on Plaque Index and oral health related quality of life(OHRQoL) in pregnant women: A randomized clinical trial
Public title
The effect of SMS reminder after oral hygiene instruction on Plaque Index and oral health related quality of life(OHRQoL) in pregnant women: A randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women who visit health center with at least 18 years old Who are willing to attend In second or third month of pregnancy Being able to read Having access to cell phone
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
We assign a number to every participant from 1 to 60 and randomization happens using computer application.
Blinding (investigator's opinion)
Double blinded
Blinding description
The examiner examines the patients, however randomization happens by the researchist. The researchist is also uninformed about plaque index of patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
No. 44, Hosseini alley, Shariati street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8173734761
Approval date
2021-11-01, 1400/08/10
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.315

Health conditions studied

1

Description of health condition studied
Plaque index- Oral health related quality of life
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plaque index- Oral health related quality of life
Timepoint
At the beginning of the study and 3 months after the start of sending reminder text messages
Method of measurement
Oral health impact profile questionnaire 14 (ohip-14) for oral health related quality of life and clinical examination by a calibrated person to evaluate plaque index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: People who receive a reminder SMS for 3 months a week on a specific day and time after a oral examination and health instruction.The general content of the messages will be about the importance of hygiene, especially during pregnancy, health recommendations and repetition of the points mentioned in the health education session.
Category
Lifestyle

2

Description
Control group: People who do not receive any reminder SMS after oral examination and health instruction.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Zeinabieh comprehensive health care center
Full name of responsible person
Adel Tabesh
Street address
No. 44, Hosseini alley, Shariati street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8173734761
Phone
+98 31 3627 2968
Email
adel.tabesh@dnt.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Isfahan university of medical sciences
City
Isfahan
Province
Isfehan
Postal code
8174673469
Phone
+98 31 3792 3120
Email
adel.tabesh@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Adel Tabesh
Position
Assistant proffessor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 44, Hosseini alley, Shariati street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8173734761
Phone
+98 31 3627 2968
Email
adel.tabesh@dnt.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Adel Tabesh
Position
assistant proffessor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 44, Hosseini alley, Shariati street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8173734761
Phone
+98 31 3627 2968
Email
adel.tabesh@dnt.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Adel Tabesh
Position
assistant proffessor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 44, Hosseini alley, Shariati street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8173734761
Phone
+98 31 3627 2968
Email
adel.tabesh@dnt.mui.ac.ir

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Can be published anonymously
When the data will become available and for how long
Post Analysis
To whom data/document is available
Public
Under which criteria data/document could be used
Request from University
From where data/document is obtainable
University
What processes are involved for a request to access data/document
letter to university
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