Abstract
Introduction: Throat of a healthy person is a rich environment for growth of different microbes. After 48 hours of hospitalization in intensive patients pharyngeal flora which are gram positive change to gram negative and this may lead to pneumonia. Additionally in patients who undergo mechanical ventilation bacteria leaked around cuff of tracheal tube may causes pneumonia.
Objectives: Comparison of the effect of green tea and chlorhexidine mouth wash on oral hygiene and throat bacterial colonies of intubated patients hospitalized in the intensive care unit bandar abbass shahid mohammadi hospital.
Methods: This study is a quasi-experimental design and conducted among 46 patients who had mechanical ventilation. Sample patients randomly divided into two groups؛ according to the crossover method, the first group in the first 4 days day with chlorhexidine solution rinse and 4 second day with a solution of green tea and the second group first 4 days with a solution of green tea mouthwash is second with chlorhexidine solution. Beck instrument has marked and patients oral hygiene were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020626402N1
Registration date:2016-05-29, 1395/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
yaser khanchemehr
Name of organization / entity
Hormozgan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 169 5259
Email address
yaserkhanchemehr@gmail.com
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of green tea and chlorhexidine mouthwash on oral hygiene and bacterial colonies in intubated patients admitted to the intensive care unit.
Public title
Mouthwash impact on oral hygiene ICU patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patient is intubated through the mouth؛ aged 65-18 years؛ less than 12 hours of ICU admission time in the past؛ before admission to the special section on the other sections have been admitted؛ avoiding the use of antibiotics before admission؛ birth control؛ no history of allergy to herbal substances؛ lack of dentures؛ lack of chronic disease and lack of immune disorder؛ the absence of any damage identified by intubation endotracheal or euros and not unknown in the mouth and around the mouth.
Exclusion criteria : The transfer of the patient from the ICU؛ died before completing his studies؛ doing any harm identified by intubation or planes or any other physical factors and not wanting to continue the study of the legal guardian of the patient.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Central organization of Kerman University of Medical Sciences - After shafa crossroad - Islamic republic boulevard - Kerman - Iran
City
Kerman
Postal code
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.KMU.REC.1394.651
Health conditions studied
1
Description of health condition studied
mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
Oral hygiene
Timepoint
The first day of intervention and fourth day of intervention and eighth day of intervention
Method of measurement
Beck oral assessment Scale And Culture of throat secretions
Secondary outcomes
1
Description
Mouth and throat infection، Plaque
Timepoint
The first day of intervention and fourth day of intervention and eighth day of intervention
Method of measurement
Culture of throat secretions، mucosal plaque score
Intervention groups
1
Description
According to the crossover method, the first group in the first 4 days with chlorhexidine solution mouthwash and 4 second days with a solution of green tea and the second group first 4 days with a solution of green tea and 4 second days with chlorhexidine solution mouthwash done. In this study patients (cases) their own controls Are. The first group in the first place by using chlorhexidine solution and a soft toothbrush tooth surfaces and tongue from back to front and rotational movements cleaned, followed by 10 ml of solution of chlorhexidine 2% in the oral cavity molding and after mouthwash green tea 5% mouthwash will thus using a solution of mouthwash green tea and a soft toothbrush levels tongue and teeth from back to front and rotational movements dirty will be cleaned at the end of day 8, recultivation from the throat of the patient is sent. In all the steps and distance between Beck and MPS mouthwash oral health assessment form will be filled. In the second group in the first stage using a solution of green tea and a soft toothbrush tooth surfaces and tongue from back to front and rotational movements cleaned, followed by 10 ml of solution mouthwash green tea 5% in the oral cavity molding and after a suction minutes throat and mouth area is performed the steps of the work for twice daily and continues for four days and again at the end of the fourth day of culture sterile technique taken from the throat area and will be sent to the shahid mohammadi hospital laboratory and the complete check list is oral hygiene. In the second phase patient for 4 days with chlorhexidine solution and a soft toothbrush and tongue from back to front tooth surfaces can be cleaned with rotational movements followed by 10 cc of spilled solution of chlorhexidine in the oral cavity and pharyngeal area and after a minute oral suction is performed. At the end of day 8 of culture from the throat to sterile technique and will be sent to the laboratory.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bandar Abbas shahid Mohammadi hospital
Full name of responsible person
yaser khanchemehr
Street address
Shahid Mohammadi hospital
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hakimeh hossein rezaei
Street address
Kerman ، Razi Nursing College
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Yaser khanchemehr
Position
Master Degree
Other areas of specialty/work
Street address
Kerman ، Razi Nursing College
City
Kerman
Postal code
Phone
+98 34 3132 5177
Fax
Email
yaserkhanchemehr@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hakimeh Hossein Rezaei
Position
Ph.D by research
Other areas of specialty/work
Street address
Kerman Nursing College
City
Kerman
Postal code
Phone
+98 34 3132 5177
Fax
Email
h_m5664@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Yaser Khanchemehr
Position
Master Degree
Other areas of specialty/work
Street address
Kerman Nursing College
City
Kerman
Postal code
Phone
+98 34 3132 5177
Fax
Email
yaserkhanchemehr@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)