Comparison of the effectiveness of two educational methods including lecturing and presenting pamphlets to parents about the observance of oral hygiene habits of pre-school children on oral health
Comparison of the effectiveness of two educational methods including lecturing and presenting pamphlets to parents about the observance of oral hygiene habits of pre-school children by measuring the Oral Hygiene Index Simplified (OHI-s).
Design
randomized, parallel, single-blind clinical trial with 40 patients. The simple randomization method has been used for randomization.
Settings and conduct
At the beginning, the simplified oral health index of all children in Shabestar preschool center is evaluated and registered by a dentist. The first group is given a lecture on oral hygiene habits in two one-hour sessions by a dentist. The teaching materials are prepared in the form of pamphlets and distributed among the second group. After 6 weeks, the simplified oral hygiene index of all children will be re-evaluated by the same dentist who is unaware of the classification. Finally, the information obtained in relation to the simplified oral health index of both groups at the beginning and end of the study will be compared and reviewed. Considering that The person examining the children's dental plaque index will not know in which study group the examined people are, Therefore, the study will be one-sided blind.
Participants/Inclusion and exclusion criteria
40 children whose plaque index is close to the average number and whose parents are literate will be included in the study and the rest will be excluded from the study.
Intervention groups
The first group (n = 20) will be assigned to the oral hygiene habits training group through lectures and the second group (n = 20) will be assigned to the pamphlet receiving group on the subject of oral hygiene habits training.
Main outcome variables
The main outcome of this project is a simplified oral health index of children, which will be measured by examining dental surfaces before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210822052251N4
Registration date:2022-11-06, 1401/08/15
Registration timing:prospective
Last update:2022-11-06, 1401/08/15
Update count:0
Registration date
2022-11-06, 1401/08/15
Registrant information
Name
Neda Yasamineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 4991
Email address
yasamineh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-12, 1401/08/21
Expected recruitment end date
2022-11-12, 1401/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of two educational methods including lecturing and presenting pamphlets to parents about the observance of oral hygiene habits of pre-school children on oral health
Public title
"Comparison of the effectiveness of two educational methods including lecturing and presenting pamphlets to parents about the observance of oral hygiene habits of children"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
40 preschool children whose parents are literate.
40 preschool children whose plaque index are almost the same.
Exclusion criteria:
Children who do not have the necessary cooperation for oral examination.
Children whose parents are unable to participate in educational sessions.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly assigned to one of two study groups with the help of a random number table and will receive the intervention of the allocated group. For allocation concealment, the method of sealed opaque envelopes which are numbered sequentially will be used. In this method, each random sequence is recorded on a card. Finally, the lids of the letter envelopes will be glued and placed inside a box. At the beginning of the study, according to the order of entry of eligible participants to study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person examining the children's dental plaque index will not know in which study group the examined people are. Therefore, the study will be one-sided blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2021-12-08, 1400/09/17
Ethics committee reference number
IR.TBZMED.REC.1400.892
Health conditions studied
1
Description of health condition studied
oral hygiene of children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
simplified oral hygiene index
Timepoint
Before intervention and 6 weeks after training
Method of measurement
Examination of dental surfaces
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: presenting pamphlets to parents
Category
Prevention
2
Description
Control group: lecturing to parents
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabestar preschool center
Full name of responsible person
Elnaz Mazaheri
Street address
Shahid Jahanbakhsh
City
Shabestar
Province
East Azarbaijan
Postal code
5389146531
Phone
+98 41 4249 5057
Email
elnaz.mazaheri.kh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad samii
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3177 1041
Email
info@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?