Effect of licorice mouthwash versus chlorhexidine mouthwash on oral health in intubated patients in intensive care unit: a double-blind randomized clinical trial
To assess the effect of licorice mouthwash versus chlorhexidine mouthwash on oral health in intubated patients in intensive care unit
Design
This is a double-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups
Settings and conduct
This study will be performed in the Beheshti Hospital in Hamadan city on 120 eligible intubated patients in intensive care unit. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Hospitalization in the intensive care unit
Having an oral tracheal tube
Having a gastric tube through the nose
Exclusion criteria:
Pregnancy
Autoimmune diseases
Pulmonary infection or sepsis
Having artificial teeth
Smoker
Intervention groups
Intervention group:
Mouth washing with 15 ml of 2% licorice mouthwash solution for 30 seconds once a day for four days.
Control group:
Mouth washing with 15 ml of 2% chlorhexidine mouthwash solution for 30 seconds once a day for four days.
Main outcome variables
Primary outcome:
Oral hygiene
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N461
Registration date:2023-02-07, 1401/11/18
Registration timing:prospective
Last update:2023-02-07, 1401/11/18
Update count:0
Registration date
2023-02-07, 1401/11/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of licorice mouthwash versus chlorhexidine mouthwash on oral health in intubated patients in intensive care unit: a double-blind randomized clinical trial
Public title
Effect of licorice mouthwash versus chlorhexidine mouthwash on oral health in intubated patients in intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Hospitalization in the intensive care unit
Having an oral tracheal tube
Having a gastric tube through the nose
Exclusion criteria:
Pregnancy
Autoimmune diseases
Pulmonary infection or sepsis
Having artificial teeth
Smoker
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unconscious, therefore, the will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-12-10, 1401/09/19
Ethics committee reference number
IR.UMSHA.REC.1401.780
Health conditions studied
1
Description of health condition studied
Oral health
ICD-10 code
Z01.20
ICD-10 code description
Encounter for dental examination and cleaning without abnormal findings
Primary outcomes
1
Description
Oral hygiene
Timepoint
On the fifth day after the intervention
Method of measurement
With clinical examination using abslang and flashlight
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mouth washing with 15 ml of 2% licorice mouthwash solution for 30 seconds once a day for four days.
Category
Treatment - Other
2
Description
Control group: Mouth washing with 15 ml of 2% chlorhexidine mouthwash solution for 30 seconds once a day for four days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital in Hamadan city
Full name of responsible person
Reza Faghih Lotfi
Street address
Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
reza_lotfi_65@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Reza Faghih Lotfi
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
reza_lotfi_65@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Khodayar Oshvandi
Position
PhD in Nursery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
oshvandi2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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