Evaluation of the effectiveness of a tooth brushing educational package on the oral health indices improvement among 5-6 years old children.
Design
this is a randomized , two-sided blinded , controlled clinical trail that will conducted among 90 participants. For random allocation of the groups, we used Lucky Ball.
Settings and conduct
Setting: Three kindergartens in regions with moderate to high SES in Isfahan City.
Participants/Inclusion and exclusion criteria
5-6 preschool children that are systematically healthy in private kindergarten of the Isfahan city.
Intervention groups
Group I: the whole package based on the COM-B model
Group II: Educational video
Group III: control
Main outcome variables
Plaque index
Gingival Index
Tooth brushing practice
Tooth brushing duration
The parents COM-b
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160822029476N2
Registration date:2023-06-02, 1402/03/12
Registration timing:prospective
Last update:2023-06-02, 1402/03/12
Update count:0
Registration date
2023-06-02, 1402/03/12
Registrant information
Name
Bahareh Tahani
Name of organization / entity
Oral Public Health Department, Dental School, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5594
Email address
tahani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of a tooth brushing educational package on the improvement of tooth brushing and gingival health of 4-6 years children: an RCT
Public title
Effectiveness of a tooth brushing package on the tooth brushing improvement among children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
5-6 preschool children that are systematically healthy in private kindergarten of the Isfahan city. .
Their parents should be alive.
Mother education should be diploma or higher.
The selection of kindergartens was in accordance to the Rehabilitation Organization located in the regions with moderate to high SES
Exclusion criteria:
Children with untreated inter-proximal dental caries, having space retainer or having oral breathing patterns
Age
From 5 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
From the proposed list of kindergartens, three will be selected randomly. Then based on the "lucky ball" randomization method, random allocation of the selected kindergartens into the three groups of Intervention I, Intervention II or control groups will be performed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participated children are not contaminated with other groups. Their teachers are not involved in the educations and not aware of the content of the interventions. The groups will be introduced to the data analyzer by English articles including A,B ,C and is not aware of the interventions contents.
Placebo
Not used
Assignment
Parallel
Other design features
After gaining ethical approvals from the Ethics Committee and signed inform consents from the parents, children will be examined to record plaque index and gingival index by one examiner (NA). The examiner will be trained by an oral public health expert and calibrated by examining 10 children before the study.Plaque index will be recorded using the Quigley-Hein index that scores the level of plaque accumulation from 0-6. The gingival index will be recorded using the (Loe Silness and Loe Gingival Index which scores the gums health from 0-3 based on the Ramford Teeth (No (55و51و65و75و71و85)). All the examinations will be performed using disposable mirrors and blunted scalers on the kindergarten chairs and using Head Light. Also, to evaluate the changes in the motivation, capability and opportunities of the parents, the checklist of COM-B self-assessment will be used. This checklist has 6 questions in 3 domains and the scoring system is based on VAS. In addition, the checklist of the oral health behavior including the time and frequency of tooth brushing, using tooth paste and duration of tooth bushing will be completed by the parents and the children, separately. Statistical Analysis: The data will be fed into SPSS 26 and using descriptive and analytical tests including Paired T-test, ANOVA, q-squared or their equivalent non-parametric tests will be analyzed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commiitee of Isfahan University of Medical Sciences
Street address
Department of Oral Public Health, School of Dentistry Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-11-19, 1401/08/28
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.246
Health conditions studied
1
Description of health condition studied
oral health status
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Dental plaque index
Timepoint
1 month
Method of measurement
Teeth examination and record in information data sheet
Secondary outcomes
1
Description
COM-B scores of parents( Capability , Opportunity , Motivation Questionnaire)
Timepoint
1 month
Method of measurement
6-questions COM-B questionnaire (with questions in domains of Capability, Opportunity, Motivation) with Visual Analogue Scale
2
Description
Gingival index
Timepoint
1 month
Method of measurement
Visual examination of gingiva and recording its status in the data collection form
Intervention groups
1
Description
Intervention group I: In the main intervention group (Group I), The behavior changes will be conducted based on the principles of COM-B; for capability improvement, a short educational video will be prepared including the explanations about the process of dental caries, the role of dental plaque, and the ways parents could utilized to remove the dental plaque mechanically. In addition, the proper use of tooth brush and tooth paste will be educated by demonstrating on two 5 and 6 children. During the demonstration, two recommended methods of tooth brushing in this age group (horizontal and roll technique) will be educated. Also, the important role and responsibility of the parents regarding the necessity of direct or supervised tooth brushing will be emphasized. The validity of the prepared videos, regarding the attractiveness, relevancy and content, will be affirmed during an expert panel evaluation including experts from the Health Education, Dental public Health and dental Pediatric departments. To improve the “opportunity” domain among parents, in a virtual group encompassing parents of the selected children, parents were encouraged to ask their questions about the methods of the tooth brushing or any comments related to the video. Also, they were asked to record and share a short film of their child’s brushing and allow the PIs (principle Investigators) to help them find their practical pitfalls. In the third domain of the model, to give children and parents relative Motivations, a 2-miutes animation was sent to the parents. This motivative animation was developed by the OIs in a recent work (oral health promoting schools) and include two singing children (a boy and a girl) who speaks about the importance and method of tooth brushing and flossing. The duration of the animation is exactly as the recommended duration of brushing and was validated in our previous works. Parents were asked to motivate their children in the time of brushing by showing them this animation. This animation is accessible through https://t.me/OHPS.
Category
Behavior
2
Description
Intervention group2: In this group just the prepared educational video will be demonstrated
Category
Behavior
3
Description
Control group: no education will be provided.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
kindergartens in Isfahan City
Full name of responsible person
Bahareh Tahani
Street address
Department of Oral Public Health, School of Dentistry Isfahan University of Medical Sciences, Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5594
Email
tahani@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Isfahan University of Medical Sciences, Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
askari@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa/dr.askari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Bahareh Tahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Hezarjarib st, Isfahan University of Medical Sciences
City
Iafahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5594
Fax
Email
tahani@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Bahareh Tahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Hezarjarib st, Isfahan University of Medical Sciences
City
Iafahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5594
Fax
Email
tahani@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Bahareh Tahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Hezarjarib st, Isfahan University of Medical Sciences
City
Iafahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5594
Fax
Email
tahani@dnt.mui.ac.ir
Web page address
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data will be available upon the request from corresponding author.
When the data will become available and for how long
Six months after the article publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
For systematic analysis
From where data/document is obtainable
Contacting the corresponding author
What processes are involved for a request to access data/document