The aim of this study is to compare the effect of Hyssop essence and Chlorhexidine Gluconate mouthwashes on oral hygiene in intubated patients in the ICU of Imam Khomeini medical educational center, Sari, Iran. This study is a double-blind randomized clinical trial. Eligible patients, will be randomly assigned to three groups : 1) 20 patients in the Zufa group, 2) 20 patients in the Chlorhexidine Gluconate group and 3) 20 patients in the Normal Saline group. Randomization will be performed through block randomization method. The method, timing and frequency of mouth washes in all groups will be done in the same way. Mouthwash volume is 15 cc and duration of washing is 30 seconds and frequency is twice a day (8 am and 4 pm). Checklist of Beck Oral Assessment Scale "BOAS" will be completed by trained nurse at the admission day and then, every day for 4 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060711399N5
Registration date:2017-06-26, 1396/04/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Abbasali Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3107 1082
Email address
ebrahimian.aa@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2017-06-30, 1396/04/09
Expected recruitment end date
2018-06-30, 1397/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Hyssop Essence and Chlorhexidine Gluconate Mouthwashes on Oral Hygiene in Intubated Patients in Intensive Care Unit
Public title
The Effect of Hyssop Essence and Chlorhexidine Gluconate on Oral Hygiene
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years; The Glasgow Coma Scale less than 8; The patient is intubated and received mechanical ventilation during the study; Non-antibiotic therapy over two weeks before hospitalization; Admission to ICU is past less than 12 hours; No history of allergy to the plants of the mint family (based on evidence of the statements of the patient's family); Having natural teeth; No history of radiation therapy; Having a Naso-Gastric Tube and no feeding by mouth. Exclusion criteria: History of radiation therapy; Diabetes; Jaw and facial injuries; Pregnant women; Using of immunosuppressive drugs such as Corticosteroids; History of seizures.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Samples will be randomly selected among one unit of intensive care units of Sari Emam Khomaini hospital.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Semnan University Of Medical Sciences
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Postal code
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.Semums.Rec.1394.69
Health conditions studied
1
Description of health condition studied
Oral Hygiene in Intubated Patients
ICD-10 code
K13.7
ICD-10 code description
Other and unspecified lesions of oral mucosa
Primary outcomes
1
Description
Oral Hygiene
Timepoint
Primery day, then daily until 4 day
Method of measurement
Check list of oral health assessment
Secondary outcomes
1
Description
Duration of stay in the intensive care unit
Timepoint
Daily
Method of measurement
Questionnaire
Intervention groups
1
Description
In the experimental group, after washing hands, the bed head is elevated 30-45 degree. After wearing sterile gloves, the pressure of cuff in the tracheal tube is regulated in the range of 20-25 cmh2o by the help of pressure manometer .Then half of Hyssop mouthwash solution 0.02% (7.5 cc) is sprinkled to different parts of the patient's mouth. Internal and external surface of the upper and lower teeth, sides and surface of tongue are cleaned with a soft pediatric toothbrush. After the brushing procedure, the other half mouthwash solution (7.5 cc) will be sprayed to different parts of the mouth. After that, the remained solution in the mouth will be suctioned using a sterile catheter in less than 30 seconds. Oral wash will be done for patients during 30 seconds, twice a day (8 am and 4 pm), for 4 days.
Category
Prevention
2
Description
In the control group, after washing hands, the bed head is elevated 30-45 degree. After wearing sterile gloves, the pressure of cuff in the tracheal tube is regulated in the range of 20-25cmH2O by the help of pressure manometer .Then half of Chlorhexidine Gluconate mouthwash solution 0.2% (7.5 cc) is sprinkled to different parts of the patient's mouth. Internal and external surface of the upper and lower teeth, sides and surface of tongue are cleaned with a soft pediatric toothbrush. After the brushing procedure, the other half mouthwash solution (7.5 cc) will be sprayed to different parts of the mouth. After that, the remained solution in the mouth will be suctioned using a sterile catheter in less than 30 seconds. Oral wash will be done for patients during 30 seconds, twice a day (8 am and 4 pm), for 4 days.
Category
Prevention
3
Description
In the placebo group, after washing hands, the bed head is elevated 30-45 degree. After wearing sterile gloves, the pressure of cuff in the tracheal tube is regulated in the range of 20-25cmH2O by the help of pressure manometer .Then half of Normal Saline mouthwash solution 0.9% (7.5 cc) is sprinkled to different parts of the patient's mouth . Internal and external surface of the upper and lower teeth, sides and surface of tongue are cleaned with a soft pediatric toothbrush. After the brushing procedure, the other half mouthwash solution (7.5 cc) will be sprayed to different parts of the mouth. After that, the remained solution in the mouth will be suctioned using a sterile catheter in less than 30 seconds. Oral wash will be done for patients during 30 seconds, twice a day (8 am and 4 pm), for 4 days.
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidi-Pour
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
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, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mehrooz Alishah
Position
MSc Student
Other areas of specialty/work
Street address
1th floor, School of Nursing and Allied Health Sciences, Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Postal code
Phone
+98 23 3365 4192
Fax
Email
Alishahmehrooz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abbasali Ebrahimian
Position
Faculty member of Semnan University of Medical Sciences
Other areas of specialty/work
Street address
Room #120, 1th floor, School of Nursing an1th floor, School of Nursing and Allied Health Sciences, Semnan University of Medical Sciences, 5th Km of Damghan Road