Evaluation of the effect of two different methods of oral health education and its repetition on the reduction of Streptococcus mutans in plaque in children 9 to 12 years old
Evaluation of the effect of two different methods of oral health education and its repetition on the reduction of Streptococcus mutans in plaque in children 9 to 12 years old
The study is performed in the pediatric dep. of dental school by 11th sem. students on the effect of two different methods of oral health education and their repetition.Method:Children are randomly grouped. Teach intervention groups. Evaluation of dental plaque in intervention and comparison groups.Blinding: People who evaluate the outcome and evaluate the data.
Participants/Inclusion and exclusion criteria
Incl. criteria: Age between 9-12years old,Children with erupted 1st molar , central and lateral incisor in both jaw that have intact surfaces .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: Includes 12children.Training done by using modeling (Educational Equipment Industries brand(EEI) , made in Iran in dimensions 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 group: Includes 12 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: they do not receive any health education, but like other groups, their SM in plaque will be measured at the end of the study.
Main outcome variables
Change in SM in dental plaque; change the level of oral and dental health education
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161119030971N5
Registration date:2022-01-30, 1400/11/10
Registration timing:registered_while_recruiting
Last update:2022-01-30, 1400/11/10
Update count:0
Registration date
2022-01-30, 1400/11/10
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
2022-01-08, 1400/10/18
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 Streptococcus mutans in plaque in children 9 to 12 years old
Public title
Evaluation of the effect of two different methods of oral and dental health education and their repetition
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Children must be between 9-12 years old
Children with erupted 1st molar , central and lateral incisor in both jaw that have intact surfaces .
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:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Using the Excel option rand software, the samples will be divided into 4 blocks based on the amount of sugar consumption by complete block randomization method, which includes: once sugar consumption per day, twice sugar consumption per day, 3 times Consumption of sugary substances per day and more than 3 times daily consumption of sugary substances. 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.1400.131
Health conditions studied
1
Description of health condition studied
Evaluation of the effect of two different methods of oral health education and its repetition .
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in SM in dental plaque
Timepoint
At the beginning , 2weeks later , 10 weeks later
Method of measurement
Specific culture medium for Streptococcus Mutans
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1 : Includes 12 children . In this group oral and dental training done by using modeling (Educational Equipment Industries brand(EEI), 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 group2: Includes 12 children . In this group oral and dental training video 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)
Category
Other
3
Description
Comparison group: unlike the Intervention groups, they do not receive any health education.But like the other groups, their SM count 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
Fax
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
100
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
Seyyed Mehdi Moshtaghioon
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
Seyyedmehdimoshtaghiun@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
Seyyed Mehdi Moshtaghioon
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
Seyyedmehdimoshtaghiun@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