Evaluation of an oral health promotion intervention program including supervised tooth brushing in comparison with not receiving supervised tooth brushing on oral health status (caries, plaque index) of 6 to7 years old school children
Evaluation of an oral health promotion intervention for 6- to 7- years old school children in Tehran
Design
The multistage cluster randomized sampling is applied including 6 to 7 years old children chosen from 19 districts of Tehran according to the Ministry of Education map. Sampling is adjusted according to the economic status in Tehran. In each strata, three district will be randomly selected and in each district, 4 schools including two girl's and two boy's schools, as intervention and control were chosen.
Settings and conduct
After obtaining informed consent, the oral health knowledge of parents will be assessed. Oral hygiene status and caries will be recorded using disposable instruments by two calibrated dentists
In the intervention group, an education workshop and a pamphlet will be delivered to parents. Also supervised brushing program will be performed at school setting after co-ordination with school officials. Free home package including toothbrush and toothpaste containing 1000 ppm fluoride will be given to students.
Post-intervention evaluation of knowledge will be performed and oral hygiene will be assessed. After 1 year follow up data will be collected in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria; 1) Healthy 6- to 7- years old children, 2) Having signed parents' informed consent
Exclusion criteria; 1) Having allergy to fluoride, 2) Children with physical disability, 3) Having systemic diseases
Intervention groups
In the intervention group, an education package including educational workshop pamphlet will be delivered. Supervised tooth brushing program will be performed at school setting and free home package including toothbrush and toothpaste containing 1000 ppm fluoride will be given to students.
Main outcome variables
Parents' knowledge of oral health; oral hygiene status and caries
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090307001749N4
Registration date:2019-02-14, 1397/11/25
Registration timing:retrospective
Last update:2019-02-14, 1397/11/25
Update count:0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Afsaneh Pakdaman
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5960
Email address
pakdaman@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of an oral health promotion intervention program including supervised tooth brushing in comparison with not receiving supervised tooth brushing on oral health status (caries, plaque index) of 6 to7 years old school children
Public title
Evaluation of a caries prevention program including supervised tooth-brushing for 6 to 7 years old school children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy 6 to 7 years old children
Having signed parents' informed consent
Exclusion criteria:
Having allergy to fluoride
Children with physical disability
Having systemic diseases
Age
From 6 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
720
Randomization (investigator's opinion)
Randomized
Randomization description
Simple cluster randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, data collectors and statistician are blind to allocation to case and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Dental Research Center, Qods st., Ehghelab Ave.
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
IR.TUMS.REC.1394.1730
Health conditions studied
1
Description of health condition studied
Caries enamel
ICD-10 code
K02.0
ICD-10 code description
Caries limited to enamel
2
Description of health condition studied
Caries of dentine
ICD-10 code
K02.1
ICD-10 code description
Caries of dentine
Primary outcomes
1
Description
Dental Plaque Index
Timepoint
At the beginning of the study (before the intervention) and 1 month and one year after the beginning of the intervention
Method of measurement
Oral and dental examination
2
Description
Caries limited to enamel
Timepoint
At the beginning of the study (before the intervention) and one year after the intervention
Method of measurement
Oral and dental examination
Secondary outcomes
1
Description
Oral health knowledge
Timepoint
Pre- and post- intervention
Method of measurement
Questionnaire
2
Description
Dental caries
Timepoint
At the beginning of the study (before intervention) and 1 year after the intervention
Method of measurement
Oral examination
3
Description
Oral Hygiene Index
Timepoint
At the beginning of the study (before intervention), one month and 1 year after the intervention
Method of measurement
Oral examination
Intervention groups
1
Description
Supervised tooth-brushing for students and workshop for parents about proper tooth-brushing of teeth
Category
Prevention
2
Description
Control group: Routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Pakdaman
Street address
Community Oral Health Department, School of Dentistry, North Kargar st.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
pakdaman@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, ُSchool of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr Pakdaman
Street address
North Kargar st.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
pakdaman@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, ُSchool of Dentistry, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Azadeh Babaei
Position
DDS/PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, North Kargar st.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
a-babaei@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Afsaneh Pakdaman
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health promotion
Street address
School of Dentistry, North Kargar st.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
a_pakdaman@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Azadeh Babaie
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Community Oral Health Department, School of Dentistry, North Kargar St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
Email
a-babaei@razi.tums.ac.ir
Web page address
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
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
There is not a plan to make this available.
When the data will become available and for how long
There is not a plan to make this available
To whom data/document is available
Editor-in-chief of Journales connected of articles
Under which criteria data/document could be used
By the request of Journal editor
From where data/document is obtainable
Department of Community Oral Health
School of Dentistry
Tehran University of Medical Science
Azadeh Babaei
a.babaei@razi.tums.ac.ir
What processes are involved for a request to access data/document