Evaluation of effectiveness of two intervention packages for oral health promotion programs on oral self care of mothers and oral health status of toddlers
Determining the effectiveness of two intervention packages for oral health promotion on oral self-care of mothers and oral health status of toddlers in non-affluent areas of Tehran city
Design
A controlled trial with three parallel arms, double-blind, randomized, on 396 samples. The rand function of Excel software was used for randomization.
Settings and conduct
Comprehensive health centers in South Tehran. First, a written consent form for the mothers ,then the basic knowledge and attitude and self-care of the mothers are recorded through an interview with a questionnaire. After that, the condition of children's primary dental plaque according to the Silness & Loe index and the dental caries index (dmft) is registered.
Participants/Inclusion and exclusion criteria
Inclusion criteria for participants: mothers with minimal reading and writing literacy and consent to participate in the project, mothers with Iranian children aged 12-24 months who refer to comprehensive health centers in the south of Tehran for routine vaccination or child growth monitoring.
Exclusion criteria for participants: mental or systemic problems of the child.
Intervention groups
The first group (mother and child level): educational booklet in the continuation of more educational materials in a virtual way
The second group (community level, change in services): in addition to the first intervention, an additional service of toothbrush and fluoride toothpaste and this incentive is renewed in the second follow-up if the care continues.
The third group (control group): Current situation and usual training in the centers.
Main outcome variables
dmft, index plaque, (knowledge, attitude, self-care of mothers for children)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131102015238N6
Registration date:2024-08-21, 1403/05/31
Registration timing:registered_while_recruiting
Last update:2024-08-21, 1403/05/31
Update count:0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
Simin Z. Mohebbi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5960
Email address
smohebbi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2024-09-15, 1403/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of two intervention packages for oral health promotion programs on oral self care of mothers and oral health status of toddlers
Public title
Evaluation of effectiveness of two intervention packages on the self-care of mothers and its effect on the oral health of toddlers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian children one to two years old who refer to comprehensive health centers in the south of Tehran for routine vaccination and growth monitoring.
Mother's minimum literacy
Mother's consent to participate in the plan.
Exclusion criteria:
Existence of systemic problems
Mental disability of the child
Age
From 1 year old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
396
Randomization (investigator's opinion)
Randomized
Randomization description
The comprehensive health centers of southern areas of Tehran city are assigned to three groups by random sampling using random sequence generation software (Excel). Two intervention groups and one control group. In the Excel software page, the left column, the total number of comprehensive centers. It shows the health of southern areas of Tehran. The three groups of the first intervention, the second intervention, and the control group are randomized with the rand command, and in the next column it is determined that we will have 7 control groups, 5 first intervention groups, and 5 second intervention groups, and in the last column, comprehensive health centers are randomly selected in are placed in one of the intervention groups. Each comprehensive health center is assigned a code. Allocation of groups to intervention arms is done by the supervisor, and the examiner, researcher and the person who performs the statistical evaluation are unaware of this randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
The examiners and the researcher who conducts the statistical evaluation and analysis are blind to the allocation of the groups.
Allocating groups to intervention arms is done by the supervisor. When entering information into the data file, groups are entered with numbers.
Depending on which intervention group they are in, the participants in this study receive educational packages through health care providers. Before receiving the services and educational packages, a questionnaire and a blind intervention-type examination were conducted in another room, and then the participants went to the health care providers and received the services. The statistical analyzer also receives the information of the health centers in the form of codes or numbers and is unaware of the intervention groups.
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
North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955943
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1402.089
Health conditions studied
1
Description of health condition studied
Oral health status of toddlers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Index (dmft)
Timepoint
First visit after 6 months and 12 months follow up
Method of measurement
Visual exam
2
Description
Plaque Index
Timepoint
First visit after 6 months and 12 months follow up
Method of measurement
Visual exam
Secondary outcomes
1
Description
Mother's knowledge about child's oral and dental health
Timepoint
Before the intervention and 6 and 12 months after the intervention
Method of measurement
Questionnaire with 22 questions
2
Description
Mother's attitude about child's oral and dental health
Timepoint
Before the intervention and 6 and 12 months after the intervention
Method of measurement
Questionnaire with 5 questions
3
Description
Mother's performance about child's oral and dental health
Timepoint
Before the intervention and 6 and 12 months after the intervention
Method of measurement
Questionnaire with 10 questions
4
Description
Mother's self-reported regarding the oral and dental health of the child and herself
Timepoint
Before the intervention and 6 and 12 months after the intervention
Method of measurement
Questionnaire with 6 questions
Intervention groups
1
Description
Intervention group: The first group (mother and child level): they will receive an educational booklet (self-care training to improve oral health and daily examination training for the child). For memorization, consolidation of information and motivation, and also the Back Teach method will be used to ensure the understanding of educational materials. The choice of the method of receiving more materials is the responsibility of the mother. (SMS/common social network/care site) children in this group are simplified by the lip the lift method after being taught by the mother herself.
Category
Lifestyle
2
Description
Intervention group: The second group (community level: change in services): In addition to the first intervention, they will have an additional service of toothbrush and fluoride toothpaste, and this incentive will be renewed if the care continues in the second follow-up
Category
Lifestyle
3
Description
Control group: The third group (control group): status quo. At the end of the intervention, this group will receive oral health education for children
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers in South Tehran
Full name of responsible person
Simin Zahra Mohebbi
Street address
End of North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
smohebbi@tums.ac.ir
Web page address
http://dentistry.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Ghods Ave
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Email
akbarisari@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Simin Zahra Mohebbi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Email
smohebbi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin ZahraMohebbi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Email
smohebbi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Zahra Mohebbi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Email
smohebbi@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After deidentifying individuals and comprehensive health centers, all data can be shared in the programs of Tehran University of Medical Sciences, comprehensive health centers of the whole country and the Ministry of Health, Treatment and Medical Education.
When the data will become available and for how long
The data access period starts 6 months after the results are published.
To whom data/document is available
Considering that the result of the work will be published as an article, the above materials will be provided to the journal (most of the international journals currently request the above materials), to be available to the interested parties. All data can be shared in Tehran University of Medical Sciences for those interested.
Under which criteria data/document could be used
Considering that the result of the work will be published as an article, the above materials will be provided to the journal (most of the international journals currently request the above materials), to be available to the interested parties.
All the data will be used for all comprehensive health centers in the country to improve the oral health status of toddlers.