Protocol summary

Summary
Poor oral health could affect children's quality of life, process of learning in the school, and their success in the future; hence, it is very essential to promote school based oral health program. The aim of this study is to evaluate how an educational intervention on teachers may affect primary school children's oral health behavior. The main including criterion is participants' willingness to taking part in the project, and leaving the study is not forbidden. Primary school teachers are the first study population who are trained. Afterwards, they teach oral health to their students as the second population study. Knowledge, attitude and practice of parents about oral health will be assessed as well. Also, children’s oral health behavior and oral health indicators are measured. Another including criterion is parents' satisfaction. Students who are afraid of oral examination are excluded from the study. A re-examination after a three-month period, and recording the oral health indices and oral health behaviors of students is planned. Results will be compared with the control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013122615806N2
Registration date: 2015-12-20, 1394/09/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-12-20, 1394/09/29
Registrant information
Name
Ahmad Jafari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5960
Email address
ajafari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Saveh University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2016-06-01, 1395/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of an educational intervention of oral health for teachers on oral health behavior among primary school children
Public title
Evaluation of an educational intervention for teachers on oral health behavior among primary school children
Purpose
Prevention
Inclusion/Exclusion criteria
Parent's permission and teachers' permission
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 400
Randomization (investigator's opinion)
Randomized
Randomization description
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
Research Center for Caries Prevention, Tehran University of Medical sciences
Street address
Tehran University of Medical sciences, Enghelab Sq., Tehran
City
Tehran
Postal code
1417614411
Approval date
2015-10-31, 1394/08/09
Ethics committee reference number
IR.TUMS.REC.1394.1061

Health conditions studied

1

Description of health condition studied
Oral hygiene
ICD-10 code
Z13.8
ICD-10 code description
Special screening examination for other specified diseases and disorders

Primary outcomes

1

Description
Oral Hygiene Index (OHI)
Timepoint
At the starting of study a
Method of measurement
Observation

Secondary outcomes

1

Description
Students/ oral health behavior
Timepoint
At the end of study
Method of measurement
questionnair

Intervention groups

1

Description
Students in intervention group will be educated by their teachers on oral health.
Category
Prevention

2

Description
Teachers are not involved in control group and students will be educated routinely.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center for Caries Prevention, Tehran University of Medical Sciences
Full name of responsible person
Dr. A Jafari
Street address
Tehran University of Medical Sciences, Enghelab Sq., Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Center for Caries Prevention, Tehran University of Medical sciences
Full name of responsible person
Dr. A Jafari
Street address
Tehran University of Medical sciences, Enghelab Sq., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center for Caries Prevention, Tehran University of Medical sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Saveh University of Medical sciences
Full name of responsible person
Jalil Kuhpayeh Zadeh
Street address
Shariati-Taleghani cross, Saveh
City
Saveh
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Saveh University of Medical sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Research Center for Caries Prevention
Full name of responsible person
Dr. A Jafari
Position
Member
Other areas of specialty/work
Street address
Enghelab Sq., Tehran University of Medical sciences
City
Tehran
Postal code
1417614411
Phone
+98 21833
Fax
+98 21 8801 5961
Email
ajafari@tums.ac.ir
Web page address
http://rccp.tums.ac.ir/fa/default.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Center for Caries Prevention, Tehran University of Medical Sciences
Full name of responsible person
Dr. A Jafari
Position
Specialist in Pediatric Dentistry
Other areas of specialty/work
Street address
Tehran University of Medical sciences, Enghelab Sq., Tehran
City
Tehran
Postal code
1417614411
Phone
+98 21 8338 4138
Fax
+98 21 8801 5961
Email
ajafari@tums.ac.ir
Web page address
http://rccp.tums.ac.ir/fa/default.aspx

Person responsible for updating data

Contact
Name of organization / entity
Research Center for Caries Prevention, Tehran University of Medical sciences
Full name of responsible person
Dr. A Jafari
Position
Specialist in Pediatric Dentistry
Other areas of specialty/work
Street address
Tehran University of Medical sciences, Enghelab Sq., Tehran
City
Tehran
Postal code
1417614411
Phone
+98 21 8338 4138
Fax
+98 21 8801 5961
Email
ajafari@tums.ac.ir
Web page address
http://tums.ac.ir/faculties/ajafari

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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