Protocol summary

Study aim
The comparison between the effects of dental brush and waterjet on dental plaque in dental students of azad university of Tehran in 2019
Design
40 students randomly selected and divided into 2 group of 20's, split mouth design has been used for this study. before the study the plaque index will be calculated with plauque disclosing tablets. for the first group they will be told to use toothbrush for the left side and waterjet for the right side.for group 2, they will do the other way round. at the end the plaque index must be calculated again to find the changes and all the result should go through SPSS and will be analyzed
Settings and conduct
type of study is clinical trial. and the candidates are from dental students of azad university of Tehran. there will be 40 students in the study. the sampling technique will be randomly done and candidates will be In group of intervention and control groups
Participants/Inclusion and exclusion criteria
inclusion criteria: 1- candidate must have dental plaque 2- candidate must be over 18 years old exclusion criteria: 1- candidate has a single missing tooth 2- candidate less than 18 years old
Intervention groups
any candidates using waterjet on any side of the jaw will be included in intervention group, and any candidates using tooth brush on the other side will be in control group
Main outcome variables
find primary and secondary plaque index, reducing in the level of plaque will be expected

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190519043638N1
Registration date: 2019-06-14, 1398/03/24
Registration timing: retrospective

Last update: 2019-06-14, 1398/03/24
Update count: 0
Registration date
2019-06-14, 1398/03/24
Registrant information
Name
Ardeshir Amirhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 7793
Email address
ardi.77@live.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2019-02-16, 1397/11/27
Actual recruitment start date
2019-02-17, 1397/11/28
Actual recruitment end date
2019-02-22, 1397/12/03
Trial completion date
2019-02-24, 1397/12/05
Scientific title
comparison of the effect of dental brush and waterjet on dental plaque
Public title
effect of dental brush and waterjet on dental plaque
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
candidate must have dental plaque
Exclusion criteria:
if any of candidates do not have dental plaque if any of candidates less than age of 18 years old if any of candidates have a missing tooth
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Not 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 azad tehran university
Street address
no 4, nayestane 10th ave, pasdaran ave, tehran
City
tehran
Province
Tehran
Postal code
1946853314
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.IAU.DENTAL.REC.1398.003

Health conditions studied

1

Description of health condition studied
dental plaque
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis

Primary outcomes

1

Description
level of dental plaque
Timepoint
primary plaque index will be calculated at the day of start of study, after using dental brush and waterjet once again the secondary dental plaque will be calculated, there is no more time fragments
Method of measurement
dental plaque disclosing tablet

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: any side of the jaw that waterjet has been used, the intervention is the waterjet itself.
Category
Treatment - Devices

2

Description
Control group: any side of the jaw that toothbrush has been used, the intervention for this group is dental brush.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Tehran Dental Branch
Full name of responsible person
dr omid moghaddas
Street address
no 4, nayestan 10th, pasdaran ave
City
tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dentaliau@ac.ir
Web page address
http://www.dentaliau.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
dental comittee
Street address
no 4, nayestan 10th, pasdaran ave
City
tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dentaliau@ac.ir
Web page address
http://www.dentaliau.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
peridontics clinics
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
Islamic Azad University
Full name of responsible person
dr. omid moghaddas
Position
periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
no 4, nayestan 10th, pasdaran ave
City
tehran
Province
Tehran
Postal code
1
Phone
+98 21 2256 4571
Email
dentaliau@ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
dr. omid moghaddas
Position
peridontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
no4, nayestan 10th, pasdaran ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dentaliau@ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
ardeshir amirhosseini
Position
dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no 1,takhti 10th,fereshteh ave
City
tehran
Province
Tehran
Postal code
۱۹۶۱۶۳۷۹۱۵
Phone
+98 21 8805 7793
Email
ardi.77@live.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
-
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
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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