Protocol summary

Summary
Background and Objectives: The aim of this study is to evaluate the best method using of chlorhexidine mouthwash in removing Streptococcus Mutans containing dental plaques through the evaluation of pathogens on person’s toothbrush. Inclusion criteria is no dental caries and exclusion criteria is disconspire with volunteer In this study, 84 dental students is randomly divided into 4 groups: 1-dipping continuously toothbrush in chlorhexidine, 2-simple washing with chlorhexidine after brushing. 3-dipping toothbrush in mouthwash for 10 minutes. 4-simple washing with water. Colony Forming Unit (CFU) of Streptococcus mutans on toothbrush is a primary outcome measure and Colony Forming Unit (CFU) of Streptococcus mutans in saliva is a Secondary outcome measure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016091529133N3
Registration date: 2016-11-06, 1395/08/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-06, 1395/08/16
Registrant information
Name
Neda Gholami
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7770 1401
Email address
dr.gholami.n@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences
Expected recruitment start date
2016-05-09, 1395/02/20
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Chlorhexidine on Decreasing Contamination of Toothbrush with Streptococcus Mutans.
Public title
Evaluating the Effect of Chlorhexidine on Decreasing Contamination of Toothbrush with Streptococcus Mutans.
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: a good oral hygine,no dental caries or periodontal desease,no mouth breathing,cleft palate,disuse mouth wash chlorhexidine in last3 weeks,ability to brushing teeth exclusion criteria:oral caries,disconspire with volunteer
Age
From 18 years old to 32 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block Randomazation

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi Square, Zanjan, Zanjan University of Medical Sciences
City
zanjan
Postal code
Approval date
2016-02-18, 1394/11/29
Ethics committee reference number
zums.rec.1394.3

Health conditions studied

1

Description of health condition studied
dental caries
ICD-10 code
k02
ICD-10 code description
K02.9

Primary outcomes

1

Description
Colony Forming Unit (CFU) of Streptococcus mutans on toothbrush
Timepoint
3 weeks after intervention
Method of measurement
Toothbrush sample collection for culture

Secondary outcomes

1

Description
Colony Forming Unit (CFU) of Streptococcus mutans in saliva
Timepoint
3 weeks after the study
Method of measurement
sampling of saliva and culture in the laboratory

Intervention groups

1

Description
Intervention Group 1: Patients kept toothbrush for 24 hours in Chlorhexidine
Category
Prevention

2

Description
Intervention Group 2: Patients kept toothbrush for 10 minutes in Chlorhexidine
Category
Prevention

3

Description
Control Group : Did not use mouthwash and just used water
Category
Placebo

4

Description
Intervention Group 3: Patients just washed the toothbrush with Clorhexidine
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of dentistry, Zanjan University of Medical Sciences
Full name of responsible person
dr neda gholami
Street address
Azadi Square, Zanjan, Zanjan University of Medical Sciences
City
zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Zanjan University of Medical Sciences
Full name of responsible person
dr Masud Vakili
Street address
Azadi Square, Zanjan, Zanjan University of Medical Sciences
City
zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Zanjan 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
دانشگاه‌ علوم‌ پزشکی‌ زنجان‌
Full name of responsible person
dr neda gholami
Position
Assistant Professor of Oral Medicine
Other areas of specialty/work
Street address
Azadi Square, Zanjan, Zanjan University of Medical Sciences
City
zanjan
Postal code
Phone
+98 24 3342 4766
Fax
Email
dr.gholami.n@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
dr neda gholami
Position
Assistant Professor of Oral Medicine
Other areas of specialty/work
Street address
Azadi Square, Zanjan, Zanjan University of Medical Sciences
City
zanjan
Postal code
Phone
+98 24 3342 4766
Fax
Email
dr.gholami.n@zums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
dr neda gholami
Position
Assistant Professor of Oral Medicine
Other areas of specialty/work
Street address
Azadi Square, Zanjan, Zanjan University of Medical Sciences
City
zanjan
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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