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Evaluation of effect of the differential learning of the horizontal scrub tooth brushing method on 6-9-year-old children’s skill problems

Protocol summary

Study aim
Determining skill problems of 6-9-year old children in learning to brush their teeth using the horizontal scrub method
Design
The clinical trial includes control groups, with parallel groups of experiment 1 and experiment 2, randomized and performed on a total of 72 children. A table of random numbers is used for randomization.
Settings and conduct
The study is conducted on elementary school students of Semnan city. After sampling, students and parents will be trained about the way of studying virtually and by pre-prepared videos and will be in contact with the presenter through virtual space during the evaluation stages. Due to the functional nature of the study, it is not possible to blind the samples.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Systemically healthy children; mastery of understanding and speaking in Persian language; Exclusion criteria: sensitivity to toothpaste; un cooperation in implementing the instructions
Intervention groups
Control group: their gingival index is controlled only at the beginning and end of the study. Experiment group 1 (I_1): They are subjected to video training in the conventional way of horizontal scrub brushing and receive daily feedback from the moderator. Experiment group 2 (I_2): they are trained to brush their teeth with a horizontal scrub through 10 pre-recorded videos in a separate manner and receive daily feedback.
Main outcome variables
Children's skill problems ;gingival bleeding index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221127056635N1
Registration date: 2023-02-15, 1401/11/26
Registration timing: prospective

Last update: 2023-02-15, 1401/11/26
Update count: 0
Registration date
2023-02-15, 1401/11/26
Registrant information
Name
Parmida Aryanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 004 8950
Email address
parmidaaryanpour2021@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-18, 1401/11/29
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of the differential learning of the horizontal scrub tooth brushing method on 6-9-year-old children’s skill problems
Public title
Evaluation of the differential learning effect of brushing children's teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Systemically healthy children; The child's mastery of understanding and speaking in Persian language Access to virtual space and softwares considered in the study A guardian who has the power to supervise and participate in the plan for the period of time.
Exclusion criteria:
physical/mental disabilities of the child or guardian; Children's sensitivity to toothpaste; The child's non-cooperation in implementing the plan's instructions; Dental pain or infection requiring immediate dental treatment
Age
From 6 years old to 9 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, we extract the necessary number of samples from the community of children aged 6-9 in Semnan schools through random cluster sampling (separately for girls' and boys' schools and different grades) and divide these children into three categories. We divide them into groups (three people in each group are matched in terms of age and sex). Then, using blocks of three, we divide each class into three groups (A, B, C). In fact, in each block of three, one person is assigned to group A, one person to group B, and one person to group C. The number of possible triple blocks is 6 (ABC, ACB, BAC, BCA, CAB, CBA). Block selection from six blocks and choosing which group A, B, and C are will be done using a table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The differential learning method that was used in this study is as follows. Through 10 pre-recorded videos that show brushing in a horizontal scrub manner separately, (including the external/internal surfaces of each of the sextants) dental and occlusal surfaces) is presented to them, they are trained. These videos are sent to the parents separately and every day, and they are asked to send a video of the child's performance of that separation movement to the supervisor after watching the training video, and the supervisor will provide feedback on each child's skill errors. The child sends to the parents. Then the movements are requested in combination in each of the facial expressions and finally in the form of the entire facial expressions.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of semnan university medical science
Street address
17 Shahrivar Boulevard; dentistry university
City
سمنان
Province
Semnan
Postal code
3519617645
Approval date
2022-10-24, 1401/08/02
Ethics committee reference number
IR.SEMUMS.REC.1401.178

Health conditions studied

1

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

Primary outcomes

1

Description
The amount of changes in the gingival bleeding index
Timepoint
Assessment of skill problems on a daily basis/Evaluation of the gingival bleeding index at the beginning of the study, on the 30th day and the 60th day from the beginning of the study
Method of measurement
wHO probe

Secondary outcomes

1

Description
The amount of changes in the gingival bleeding index
Timepoint
Evaluation of skill problems on a daily basis / evaluation of the gingival bleeding index at the beginning of the study, on the 30th day and the 60th day from the beginning of the study
Method of measurement
by gingival probing

Intervention groups

1

Description
The educational video is sent to the parents through the virtual space, and the children are given toothbrushes and toothpaste suitable for the age group in the school, and their parents are asked to send the video of the child brushing teeth to the supervisor every day after watching the educational video. Every night, the supervisor provides feedback on the child's skill errors to the parents of this group.
Category
Prevention

2

Description
They are trained by 10 pre-recorded videos that present brushing in a horizontal scrub manner separately (including external/internal surfaces of each dental sextant and occlusal surfaces). These videos are sent to the parents separately and every day, and they are asked to send a video of the child's execution of the separation movement to the supervisor after watching the educational video, and the supervisor gives feedback on the skill errors of each child to the parents. he sends. Then the movements are requested in combination in each of the facial expressions and finally in the form of the entire facial expressions.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Balal school
Full name of responsible person
Seyede Fatemeh Pachenari
Street address
17 Shahrivar Boulevard
City
semnan
Province
Semnan
Postal code
3519617645
Phone
+98 912 004 8950
Email
parmidaaryanpour2021@gmail.com3519617645

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyede Fatemeh Pachenari
Street address
17 Shahrivar Boulevard
City
Semnan
Province
Semnan
Postal code
3519617645
Phone
+98 911 319 3019
Email
pachenari.dds@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
ParmidaAryanpour
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Health Promotion
Street address
17 Shahrivar boulevard
City
semnan
Province
Semnan
Postal code
3519617645
Phone
+98 912 004 8950
Email
parmidaaryanpour@gmailcom

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyede Fatemeh Pachenari
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
17 Shahrivar boulevard
City
semnan
Province
Semnan
Postal code
3519617645
Phone
+98 911 319 3019
Email
pachenari.dds@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyde Fatemeh Pachenari
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
17 Shahrivar boulevard
City
semnan
Province
Semnan
Postal code
3519617645
Phone
+98 911 319 3019
Email
pachenari.dds@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Personal data of participants can be shared after de-identification.
When the data will become available and for how long
The access period starts 12 months after the publication of the results.
To whom data/document is available
researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of statistical analysis on the data of this study is not allowed.
From where data/document is obtainable
Parmida Aryanpour/dentistry university of semnan/09120048950/parmidaaryanpour2021@gmail.com
What processes are involved for a request to access data/document
The request of people who are eligible to receive data should be sent to parmida aryanpour by email. parmidaaryanpour2021@gmail.com
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