Protocol summary

Summary
The aim is Comparison of the effects of education (Health education with or without learning about tooth decay or bad breath) in Motivating the promotion of oral health indicators in the first high school students in Yazd. A Single-blind randomized controlled study included 195 school students (girls and boys) is designed that have not known Respiratory diseases, gastrointestinal, renal, hepatic or acute dental caries.Demographic characteristics, health behaviors, modified gingival index and plaque index, halitosis rate and self- assessment of halitosis rate will register.The control group will receive only oral health education and The second group will receive oral health education and teaching about caries and periodontal diseases and third group will receive oral health education and teaching about halitosis.Examinations are repeated after 2 weeks and 2 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012122611888N1
Registration date: 2013-08-04, 1392/05/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-04, 1392/05/13
Registrant information
Name
Motahare Amiri
Name of organization / entity
Yazd Dental Faculty
Country
Iran (Islamic Republic of)
Phone
+98 35 1625 5881
Email address
motahare.amiri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadooghi Dental Faculty of Yazd
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment of effect of traditional oral hygiene and halitosis-base education on oral hygiene indices in Yazd freshman high school students
Public title
Effect of oral hygiene education based on halitosis education on oral hygiene
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: freshman student Exclusion criteria: known Respiratory diseases; gastrointestinal; renal; hepatic ; acute dental caries
Age
From 15 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 195
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Yazd University of Medical Sciences
Street address
Bahonar Square
City
Yazd
Postal code
Approval date
2013-03-17, 1391/12/27
Ethics committee reference number
17/1/188715/پ

Health conditions studied

1

Description of health condition studied
halitosis
ICD-10 code
R19.6
ICD-10 code description
International Statistical Classification of Diseases and Related Health Problems 10th Revision

Primary outcomes

1

Description
halitosis
Timepoint
befor intervension and 2 weeks and 2 months after intervension
Method of measurement
smelling

2

Description
modified gingival index
Timepoint
befor intervension and 2 weeks and 2 months after intervension
Method of measurement
modified gingival index by lobebe R.R method

3

Description
plaque index
Timepoint
befor intervension and 2 weeks and 2 months after intervension
Method of measurement
by loe H, silness method

4

Description
self assesment of halitosis
Timepoint
befor intervension and 2 weeks and 2 months after intervension
Method of measurement
one's speach

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: To one group be given oral hygiene education and training about halitosis at a meeting.
Category
Prevention

2

Description
Intervention group:To one group be given oral hygiene education and training about caries and gingival disease at a meeting.
Category
Prevention

3

Description
control group:To one group be given oral hygiene education at a meeting.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Vaziri high school
Full name of responsible person
Hadi Taghvaei
Street address
Imam Street
City
Yazd

2

Recruitment center
Name of recruitment center
Entezari high school
Full name of responsible person
Ghazanfar Jafarpoor
Street address
Khayam Street, BLV of Dahe fajr
City
Yazd

3

Recruitment center
Name of recruitment center
Dr. Batool Imamhoseini high school
Full name of responsible person
Farahnaz emadi
Street address
BLV of Dahe fajr
City
Yazd

4

Recruitment center
Name of recruitment center
Meshkat high school
Full name of responsible person
Parvin Abooei
Street address
BLV of Modares, Shohada Mehrab Square
City
Yazd

5

Recruitment center
Name of recruitment center
Fatemieh high school
Full name of responsible person
Marieh Taheri
Street address
Mahdi Street
City
Yazd

6

Recruitment center
Name of recruitment center
markar high school
Full name of responsible person
Street address
City
yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental Faculty
Full name of responsible person
Dr. Davari
Street address
Fazaie sabz
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Faculty
Proportion provided by this source
100
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
Dental Faculty
Full name of responsible person
Motahare Amiri
Position
Assistant professor of operative and cosmetic dentistry
Other areas of specialty/work
Street address
Fazaie sabz
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
_
Email
motahare_amiri@yahoo.com
Web page address
_

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Dental Faculty
Full name of responsible person
Motahare Amiri
Position
Assistant professor of operative and cosmetic dentistry
Other areas of specialty/work
Street address
Fazaie sabz
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
_
Email
motahare_amiri@yahoo.com
Web page address
_

Person responsible for updating data

Contact
Name of organization / entity
Yazd Dental Faculty
Full name of responsible person
Motahare Amiri
Position
assistant professor of operative and cosmetic detistry
Other areas of specialty/work
Street address
Fazaie sabz
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
Email
motahare_amiri@yahoo.com
Web page address

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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