Protocol summary

Summary
Aims: The aim of this study was to compare the effect of different educational methods of tooth brushing (lecture, video and pamphlet) on dental plaque index of 12 year-old children. Design: A cluster randomized not blinded interventional trial was performed in January to April 2017 on 128 children aged 12years in public and private schools of Babol city (north of Iran). The participants were randomly allocated into four groups based on the type of intervention; group 1: no intervention, group 2, 3, 4: education via lecture, video and pamphlet, respectively (n=32). Method: Plaque index (PI) was determined by oral examination at the baseline and 2 month later for group1. Also it was recorded before education and 24 hours, 1 and 2 months later for groups 2, 3, 4. Participants: Healthy children who had the teeth # 11, 16, 26, 31, 36, and 46 were included and who were dissatisfied to participate in the study or had physical and mental problems that limited learning ability, had a painful tooth in the mouth or sensitivity to toothpaste and a large dental calculus were excluded. Interventions: Education of tooth brushing via lecture, video and pamphlet. Outcome: Plaque index before and after the education.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080721519N5
Registration date: 2017-10-29, 1396/08/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-29, 1396/08/07
Registrant information
Name
Samane Gharekhani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
s.gharekhani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2017-01-01, 1395/10/12
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of tooth brushing education via video, lecture and pamphlet on dental plaque index of 12 year old children
Public title
the effect of tooth brushing education via video, lecture and pamphlet on dental plaque index of 12 year old children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: healthy children; having teeth part in plaque index (11, 16, 26, 31, 36, and 46) Exclusion criteria: dissatisfaction of children to participate in the study; physical and mental problems that limited learning ability; Having painful tooth in the mouth; sensitivity to toothpaste; having a large dental calculus.
Age
From 12 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz street
City
Babol
Postal code
47176-47745
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
1395.260

Health conditions studied

1

Description of health condition studied
Dental caries
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified

2

Description of health condition studied
Gingivitis and periodontal diseases
ICD-10 code
k05
ICD-10 code description
Gingivitis and periodontal diseases

Primary outcomes

1

Description
Dental plaque index
Timepoint
0,24 h and 2 month later
Method of measurement
Oral examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 2: Tooth brushing education with Bass technique via lecture and a dental model for the same time of 10 minutes
Category
Other

2

Description
control group: no intervention
Category
N/A

3

Description
Intervention group 3: Tooth brushing education with Bass technique via a researcher-made video in form of animation and film for the same time of 10 minutes
Category
Other

4

Description
Intervention group 4: Tooth brushing education with Bass technique via a resercher-made pamphlet with both pictures and text which was read by children within the same time of 10 minutes and was given to them for using at home
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Schools
Full name of responsible person
Street address
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy of Babol University of Medical Sciences
Full name of responsible person
Dr. Moghadamnia
Street address
Ganjafrooz street
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Samane Gharekhani
Position
Assistant Professor
Other areas of specialty/work
Street address
Ganjafrooz street
City
Babol
Postal code
Phone
+98 11 3219 9592
Fax
Email
sgharekhani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Samane Gharekhani
Position
Assistant Professor
Other areas of specialty/work
Street address
Ganjafrooz street
City
Babol
Postal code
Phone
+98 11 3219 9592
Fax
Email
sgharekhani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
samane gharekhani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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