Comparison of the effect of the topic of education (health education with or without education about bad breath or gum and decay) in motivating the promotion of oral health indicators in a group of third grade elementary school students in Yazd
Design
Clinical trials with a control group, community-based and pragmatic
Settings and conduct
This study was performed on three types of health education in six primary schools of Yazd.Then 1 and 6 months later the training was repeated and In each of the three periods, the plaque index and the modified gingival index and bad breath were measured.
Participants/Inclusion and exclusion criteria
Entry requirements: Third grade elementary school students in Yazd؛Conditions of non compliance: Disabling physical or mental illness, acute dental caries
Intervention groups
Bad Breath group:receive bad breath thematic education and oral health
education
Gum and Decoy group:receive Gum and Decoy thematic education and oral health education
Control group: receive oral health education
Main outcome variables
Plaque index, Modified gingival index, Bad breath index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180526039842N1
Registration date:2018-09-26, 1397/07/04
Registration timing:retrospective
Last update:2018-09-26, 1397/07/04
Update count:0
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
Faezeا Fotoohi ardekani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5881
Email address
f.fotoohi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-21, 1395/06/31
Expected recruitment end date
2016-10-05, 1395/07/14
Actual recruitment start date
2016-09-21, 1395/06/31
Actual recruitment end date
2016-10-21, 1395/07/30
Trial completion date
2018-05-04, 1397/02/14
Scientific title
Comparative assessment of effect of traditional oral hygiene and halitosis-base education on oral hygiene indicates in 9-10 years old students
Public title
Comparison of the effect of oral health education in three different ways
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Third elementary student
Exclusion criteria:
People with debilitating illnesses
people who were not in one of the fallopians
People with acute dental caries
Age
From 9 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Random unit: cluster
Randomization Tool: Random Numbers
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
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Yazd, Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2017-02-20, 1395/12/02
Ethics committee reference number
IR.SSU.REC.1395.230
Health conditions studied
1
Description of health condition studied
Effect of the topic of oral health education
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Plaque index
Timepoint
Measuring plaque index at the beginning of the study (before intervention) and 1 and 6 months after the start of the study
Method of measurement
Calculate the ratio of dental plaque dental surfaces to total dental surfaces in the mouth (except the occlusal surface)
2
Description
Modified gingival index
Timepoint
Measuring plaque index at the beginning of the study (before intervention) and 1 and 6 months after the start of the study
Method of measurement
0-Non-inflammation 1-Mild inflammation, slight changes in color and texture of each part except marginal and papillary gingivitis 2-Mild inflammation, slight changes in color and tissue that are involved in marginal and papillary gingivitis 3- Moderate inflammation, redness and edema, and gingival hypertrophy Marginal and papillary 4-severe inflammation, reddened edema and / or marginal and papillary gingivitis, spontaneous bleeding and ulceration
3
Description
Halitosis
Timepoint
Measuring plaque index at the beginning of the study (before intervention) and 1 and 6 months after the start of the study
Method of measurement
Organoleptic test
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Receive the theoretical lesson of bad breath and oral health education at the beginning of the study and 6 months after the start of the study.
Category
Other
2
Description
Second intervention group: Receive the theoretical lesson of gum and tooth decay and oral health education at the beginning of the study and 6 months after the start of the study.
Category
Other
3
Description
Control group: Receive oral health education
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Education and training of Yazd
Full name of responsible person
Abbas Ali Danaei Far
Street address
Paknejad Blvd
City
Yazd
Province
Yazd
Postal code
89195668
Phone
+98 35 3314 4301
Email
info@yazdedu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahmoud Vakili
Street address
Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916844933
Phone
+98 35 3726 3733
Email
vakilim52@ssu.ac.ir
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
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
Yazd University of Medical Sciences
Full name of responsible person
Faezeh Fotouhi Ardakaniد
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Beginning of the of Dahe Fajr Blvd ,Imam Khomeini Street (RA),
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
f.fotoohi@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Faezeh Fotouhi Ardakani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Beginning of Fajr Blvd,Imam Khomeini Avenue
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
f.fotoohi@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Faezeh Fotouhi Ardakani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Beginning of Fajr Blvd,Imam Khomeini Street.
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
f.fotoohi@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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