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Evaluation of the effect of two different methods of oral health education and its repetition on the reduction of microbial plaque in children 9 to 12 years old

Protocol summary

Study aim
Evaluation of the effect of two different methods of oral health education and its repetition on the reduction of microbial plaque in children 9 to 12 years old
Design
clinical trial ,Single blind ,simple randomization,sample number:60 persons
Settings and conduct
The study is performed in the pediatric dep. of dental school of Islamic Azad Uni. by 11th sem. students on the effect of two different methods of oral health education and the effect of their repetition.Method:Children are randomly grouped.Oral health education to intervention groups . Evaluation of dental plaque in intervention and comparison groups at the end of the study . Blinding: People who evaluate the outcome and evaluate the data.
Participants/Inclusion and exclusion criteria
Inc. criteria: Age between 9-12 years old. Excl. criteria: children with mental and physical disabilities,children with fixed or movable orthodontic appliance,children with Abscess,children with teeth crowding,children who use mouthwash,children with systemic disease,children who take drugs that affect the condition of the gums.
Intervention groups
Intervention group 1: Includes 20 children .Training done by using modeling (EEI Educational Industries brand, made in Iran in dimensions three times bigger than normal size, 19x14x14 cm) , once, at the beginning.Then the training will be repeated every two weeks from the beginning. (Generally 4 times in two months) Intervention group2: Includes 20 children.In this group video training will be done once, at the start time, then, the training will be repeated every two weeks from the start time. (Generally 4 times in two months) Comparison group: plaque index will be determine at the beginning, they do not receive any health education, but their plaque will be measured at the end of the study.
Main outcome variables
Dental plaque change; Changing the level of oral health knowledge.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161119030971N4
Registration date: 2022-01-14, 1400/10/24
Registration timing: registered_while_recruiting

Last update: 2022-01-14, 1400/10/24
Update count: 0
Registration date
2022-01-14, 1400/10/24
Registrant information
Name
Nahid Askarizadeh
Name of organization / entity
Dental branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21225645713
Email address
n_asgarizadeh@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-09, 1400/10/19
Expected recruitment end date
2022-03-09, 1400/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of two different methods of oral health education and its repetition on the reduction of microbial plaque in children 9 to 12 years old
Public title
Evaluation of the effect of two different methods of oral health education and its repetition .
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
children must be between 9-12 years old
Exclusion criteria:
children with mental and physical disabilities children with fixed or movable orthodontic appliance children with Abscess children with teeth crowding children who use mouthwash children with systemic disease children who take drugs that affect the condition of the gums
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Using the rand function of Excel software, the samples will be assigned into 3 research group by block randomization with block of size of 4. This process is performed by a person who is not present in the clinical work and follow-up of patients (statistics and methodology consultant) and the type of intervention will be provided to the researcher in envelopes in numbered packages and the researcher will open the lock immediately The type of specialized intervention will be informed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind in that the outcome assessor and data analyst were both unaware of the groups when examining the indicators.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Dental College Medical Sciences of Islamic Azad University
Street address
Dental College ,Medical Sciences , Islamic Azad University No.9, 9th Neyestan Alley ,Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585/175
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.132

Health conditions studied

1

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

Primary outcomes

1

Description
Reduce dental plaque
Timepoint
At the beginning , 2weeks later , 10 weeks later
Method of measurement
O'Leary plaque index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Includes 20 children . In this group teaching how to brush and floss done by using modeling (EEI Educational Industries brand, made in Iran in dimensions three times bigger than normal size, 19x14x14 cm) , once, at the beginning. Then the training will be repeated every two weeks from the beginning. (Generally 4 times in two months)
Category
Other

2

Description
Intervention group 2: including 20 goodies. In this group, the training of brushing and flossing through the film will be done once, at the beginning, then, once every two weeks from the beginning, the training will be repeated. (Generally 4 times in two months)
Category
Other

3

Description
Comparison group: unlike the Intervention groups, they do not receive any health education. But like the other groups, their Plaque index will be measured again at the end of the study
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental College Medical Sciences of Islamic Azad University
Full name of responsible person
Nahid Askarizadeh
Street address
Dental College ,Medical Sciences , Islamic Azad University No.9, 9th Neyestan Alley ,Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2276 3459
Email
nahidaskarizadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Askarizadeh
Street address
No.4 , 8th Baharestan Alley , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
37334009000
Phone
+98 21 2277 9836
Email
nahidaskarizadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
30
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Shamim Eshaghi Nasab
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neyestan Alley ,Pasdaran Ave.,Dental College of MedicalSciences , Islamic Azad University
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2251 2134
Email
shamim.eshaghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Askarizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neyestan Alley ,Pasdaran Ave.,Dental College of Medical Sciences , Islamic Azad University
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Email
nahidaskarizadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shamim Eshaghi nasab
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neyestan Alley ,Pasdaran Ave.,Dental College of Medical Sciences , Islamic Azad University
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2251 2134
Email
shamim.eshaghi@gmail.com

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
there is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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