Protocol summary

Study aim
Improving oral and dental health behaviors in pregnant women
Design
A clinical trial with a control group, with parallel groups on 200 randomized pregnant mothers using the rand function of Excel software based on the number of cases of mothers in two control and intervention groups.
Settings and conduct
Gillard Health Centers and Hazrat Fatemeh Hospital, Damavand city, based on the knowledge and attitudes of mothers towards oral and dental health
Participants/Inclusion and exclusion criteria
pregnancy
Intervention groups
Intervention group = oral health education during pregnancy and health assessment before and after education Evaluation control group = oral health evaluation
Main outcome variables
Knowledge and attitude-self-efficacy

General information

Reason for update
Acronym
HB M
IRCT registration information
IRCT registration number: IRCT20240106060631N1
Registration date: 2024-03-04, 1402/12/14
Registration timing: prospective

Last update: 2024-03-04, 1402/12/14
Update count: 0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Mojgan Faezi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2205 7611
Email address
drm.faezi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral health education program based on health belief model in improving oral health behaviors in pregnant women refferd to Jilard health center and Hazrate Fatemeh hospital in Damavand city in 1402-1403
Public title
The effect of oral health education program based on health belief model in improving oral health behaviors in pregnant women refferd to Jilard health center and Hazrate Fatemeh hospital in Damavand city
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women referred in the first, second and third trimesters ability to read and write
Exclusion criteria:
Pregnant women referred in the first, second and third trimesters
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the last file number - scores of the individual in the control group. even scores in the intervention group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه شاهد
Street address
hahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-01-08, 1402/10/18
Ethics committee reference number
IR.SHAHED:REC.1402.100

Health conditions studied

1

Description of health condition studied
Decad tooth
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effect of education on the knowledge and attitude of pregnant mothers on oral health
Timepoint
3 days a week from 9:00 a.m. to 1:00 p.m
Method of measurement
Knowledge and Attitude Questionnaire (Dr. Bahramian - Dr. Mohebi) - Self-Efficacy Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention: training to change attitudes and knowledge to increase oral and dental hygiene during pregnancy
Category
N/A

2

Description
Control group: Routine training in Mangahi
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatima Hospital
Full name of responsible person
Mojgan Faezi
Street address
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
18735/136
Phone
+98 912 533 0133
Email
drm.faezi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Mojgan Faezi
Street address
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 912 533 0133
Email
drm.faezi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Mojgan Faezi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
hahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
9008 21 55228800
Email
drm.faezi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mojgan Faezi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Email
drm.faezi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mojgan Faezi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
0098 21 51210
Email
drm.faezi@gmail.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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