Comparing the efficacy of Chlorhexidine 0.2% and Povidone-Iodine 10% on preoperative skin preparation before intraoral surgeries
Design
Not-blinded clinical trial with control group
Settings and conduct
In this study, the skin around the mouth is divided into two left and right part from the nose to the chin, firstly. Some samples are taken individually from the right and left. Then we apply Chlorhexidine 0.2% to the left side and Povidone- Iodine 10% to the right side. We immediately take some samples from the left side; but do it after three minutes for the right side. The samples will be taken by sterile swab and placed in a test tube containing TSB(Tryptic soy broth). Cultivation is carried out in the blood agar environment by swab. After 24 hours of incubation, the grown colonies will be counted and the results will be compared. The site of study is the Periodontology Department of Ahvaz Jundishapur Dentistry Faculty and the Microbiology Department of Jundishapur Medical Faculty.
Participants/Inclusion and exclusion criteria
Male healthy non smoker patients
Intervention groups
The samples are taken before any intervention, as well as after using Chlorhexidine 0.2% in one side and Povidone- Iodine 10% in other side, from the left and right side of skin around the mouth, separately.
Main outcome variables
The number of bacterial colonies
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181017041365N1
Registration date:2019-05-04, 1398/02/14
Registration timing:retrospective
Last update:2019-05-04, 1398/02/14
Update count:0
Registration date
2019-05-04, 1398/02/14
Registrant information
Name
Negin Ostadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 7185
Email address
ostadian.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of chlorhexidine 0.2% and povidone-iodine 10% on preoperative skin preparation before intraoral surgeries
Public title
Comparing the efficacy of chlorhexidine 0.2% and povidone-iodine 10% on preoperative skin preparation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy persons
Exclusion criteria:
Skin disease
Smokers
Systemic disease
Age
From 20 years old to 30 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
57
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Science
Street address
Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.AJUMS.REC.1397.264
Health conditions studied
1
Description of health condition studied
Preoperative skin preparation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Number of bacterial colonies before and after applying Chlorhexidine 0.2% and Povidone- Iodine 10% to the perioral skin
Timepoint
Counting bacterial colonies after 24 hours incubation
Method of measurement
Counting bacterial colonies
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: first intervention group: left side of the skin around their mouth will be prepared with Chlorhexidine 0.2 % mouthwash Irandaru Factory, second intervention group: right side of the skin around their mouth will be prepared with Povidone- Iodine 10% Darudarman Factory
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundi Shapur University Of Medical Sciences Scool Of Dental Medicine
Full name of responsible person
Dr Navid Dorestan
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5169
Email
Navid.dorestan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badavi
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3336 7543
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz 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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Navid Dorestan
Position
Asistant Professor Of Periodontology
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3391 1313
Email
Navid.dorestan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Navid Dorestan
Position
Periodontologist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3391 1313
Email
Navid.dorestan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Navid Dorestan
Position
Periodontologist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3391 1313
Email
Navid.dorestan@gmail.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
No more information
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
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