Comparison of the effect of thyme mouthwash and chlorhexidine gluconate on the oral health of ventilated patients in the intensive care unit
Design
A controlled, parallel-group, triple-blind, randomized, phase three clinical trial on 46 patients. Random allocation software will be used for randomization.
Settings and conduct
Patients will be divided into two groups receiving thyme mouthwash and chlorhexidine. Before each intervention, the position of the patient supine and if not prohibited, the patient's head will be raised 30 degrees. Before the intervention, the entire surface of the mouth, gums and teeth were brushed with a soft toothbrush for both groups, and then for the patients in the two groups, mouthwash with thyme and chlorhexidine three times a day and with 5 ml of mouthwash in the form of a swap or a wet brush. It will be done for 5 days. Before the intervention, two and five days after the intervention, the oral health will be evaluated with the oral health evaluation tool.
Participants/Inclusion and exclusion criteria
Intubated patients in intensive care unite
1) Require mechanical ventilation for at least 48 hours
2) No history of allergy to herbal compounds
3) Not using an endotracheal tube before hospitalization in intensive care unit
4) Having a nasogastric tube for feeding
5) Not getting pneumonia during hospitalization in intensive care unit
6) older than 18 years old
7) Consent to participate in the study by the patient or guardian
8) Not having obvious oral lesions in and around the mouth at the time of admission
9) The airway used for the patient is a tracheal tube
10) Not having an autoimmune disease or immune system deficiency
Intervention groups
The intervention groups: the group receiving thyme mouthwash and chlorhexidine.
Main outcome variables
oral health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221119056537N1
Registration date:2023-08-10, 1402/05/19
Registration timing:prospective
Last update:2023-08-10, 1402/05/19
Update count:0
Registration date
2023-08-10, 1402/05/19
Registrant information
Name
Haniyeh Samarghandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5551
Email address
samarghandih992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-05, 1402/06/14
Expected recruitment end date
2023-10-06, 1402/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Thyme and Chlorhexidine glucosan mouthwash on oral health of ventilated patients in the intensive care unit
Public title
Comparison of the effect of Thyme and Chlorhexidine glucosan mouthwash on oral health of ventilated patients in the intensive care unit
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
1) Older than 18 years old
2) The patient needs mechanical ventilation at least for 48 hours
3) The airway used for the patient is a tracheal tube.
4) Not using an endotracheal tube before admission to the intensive care unit
5) Consent to participate in the study by the patient or guardian
6) Not having pneumonia during hospitalization in the intensive care unit
7) No history of allergy to herbal compounds
8) Not having an autoimmune disease or immune system deficiency
9) Absence of obvious lesions in and around the mouth upon admission
Having a nasogastric tube for feeding
Exclusion criteria:
pregnancy
extubation
transfer from the intensive care unit to the ward or death of the patient
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization guarantees that there is no significant imbalance between the groups at any time during the randomization and at certain points the number of participants in each group is equal. Then the list of blocks is written and numbers are assigned to them (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) then choosing random numbers between 1 to 6 (for example 1 4 5 and...) and finally defining the treatment allocation list based on the previous random numbers (...AABB-BBAA-BABA-). In this design, the randomization unit is individual.
Blinding (investigator's opinion)
Triple blinded
Blinding description
1) The study participants are blind due to their low level of consciousness and being intubated.
2) The researcher will only apply chlorhexidine and thyme mouthwash by numbering them and will not know the identity of each mouthwash.
3) Statistical analysts will also analyze the data through coding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences, School of Nursing and Midwifery
Street address
University St., Doctor's Road, Faculty of Nursing and Midwife
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.038
Health conditions studied
1
Description of health condition studied
Intubated patients hospitalized in intensive care unite
ICD-10 code
J39
ICD-10 code description
Other diseases of upper respiratory tract
Primary outcomes
1
Description
Oral health score in oral health assessment questionnaire
Timepoint
Before the intervention, two and five days after using thyme and chlorhexidine mouthwash
Method of measurement
oral health assessment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before each intervention, the patient's position will be supine, and if not prohibited, the patient's head will be raised 30 degrees and turned to one side. Before using the mouthwash to prevent microaspiration, the tracheal tube cuff pressure will be measured once for both groups, and then the cuff stiffness method will be used for the next times to ensure the appropriate pressure of the cuff. Before the intervention, the entire surface of the mouth, gums and teeth will brushed with a soft toothbrush. For patients in the intervention group, five milliliters of thyme mouthwash will be administered three times a day (every eight hours) as a wet swab for five days.
Category
Other
2
Description
Control group: Before each intervention, the patient's position will be supine, and if not prohibited, the patient's head will be raised 30 degrees and turned to one side. Before using the mouthwash to prevent microaspiration, the tracheal tube cuff pressure will be measured once for both groups, and then the cuff stiffness method will be used for the next times to ensure the appropriate pressure of the cuff. Before the intervention, the entire surface of the mouth, gums and teeth will brushed with a soft toothbrush. For patients in the intervention group, five milliliters of Chlorhexidine mouthwash will be administered three times a day (every eight hours) as a wet swab for five days.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
Haniyeh Samarghandii
Street address
Ahmedabad Street, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Fax
+98 51 3845 3239
Email
b.ghaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
College of Nursing and Midwifery, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
97165-91778
Phone
+98 51 3879 5031
Fax
+98 51 3843 6827
Email
presidentoffice@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Haniyeh Samarghandi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Univercity street
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3859 1511
Email
samarghandih992@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Haniyeh Samarghandi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University street
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3859 1511
Email
samarghandih992@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Haniyeh Samarghandi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University street
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3859 1511
Email
samarghandih992@mams.ac.ir
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