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Comparative study of the effect of two solutions of Chlorhexidine and sodium bicarbonate mouthwash on the onset of Covid-19 related symptoms in vaccinated operating room staff

Protocol summary

Study aim
Comparative determination of the effect of two solutions of Chlorhexidine and sodium bicarbonate mouthwash on the onset of symptoms attributed to Covid-19 in vaccinated operating room staff of selected hospitals of Isfahan University of Medical Sciences in 2022
Design
A controlled clinical trial with parallel, double-blind, randomized groups on 120 patients. To divide the subjects into intervention and control groups, random allocation method and table of random numbers will be used.
Settings and conduct
This study will be performed in selected hospitals of Isfahan. The intervention groups will receive Chlorhexidine mouthwash and sodium bicarbonate mouthwash and the control group receives placebo. Mouthwash and placebo will be used for two weeks, twice a day, 15 ml each time for one minute. From the start of mouthwash solutions until four weeks later, the studied samples will be monitored. To double-blind the study, participants will be unaware of the type of mouthwash solution and the data analyzer will be unaware of the details of the grouping.
Participants/Inclusion and exclusion criteria
Get at least two doses of the vaccine, Personnel range of 18-60 years, Do not get Covid-19 in the last two months, No symptoms of systemic infection, Do not take immunosuppressive drugs, No history of allergy to mouthwash solutions, At least 2 weeks have passed since the second dose of the vaccine was given, No pregnancy, No breastfeeding
Intervention groups
The intervention groups will receive chlorhexidine mouthwash and sodium bicarbonate mouthwash, and the control group received placebo (water). Mouthwash and placebo will use for two weeks, twice a day, 15 ml each time for one minute. From the start of mouthwash solutions until four weeks later, the samples will be monitored for symptoms. If necessary, PCR test will also be taken.
Main outcome variables
Covid-19 symptoms, PCR test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220328054364N1
Registration date: 2022-06-21, 1401/03/31
Registration timing: prospective

Last update: 2022-06-21, 1401/03/31
Update count: 0
Registration date
2022-06-21, 1401/03/31
Registrant information
Name
Hanieh Karami chamgordani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5224 4758
Email address
haniehkarami@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of two solutions of Chlorhexidine and sodium bicarbonate mouthwash on the onset of Covid-19 related symptoms in vaccinated operating room staff
Public title
Evaluation of the effectiveness of Chlorhexidine and sodium bicarbonate mouthwash solutions on the onset of Covid-19 symptoms
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Personnel with an age range of 18-60 years Get at least two doses of the vaccine At least two weeks have passed since the second dose of the vaccine was given
Exclusion criteria:
Pregnant personnel Breastfeeding period History of allergy to mouthwash solutions Taking immunosuppressive drugs Having Covid-19 in the last two months Having symptoms of systemic infection
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the researcher first enters the study of the operating room personnel by calling in the research environment and explaining the title, taking into account the inclusion criteria, by easy sampling method. In order to balance the number of samples assigned to each of the study groups, the block randomization method will be used and the size of each block will be considered 3. For random allocation with random blocks, a valid website (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used, then the samples will be placed in each of the intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the study and not inform the staff about the type of mouthwash, the type of solution is not written on the bottles and the type of solution will be determined using coding. Also the bottles are made similar and opaque, and the food coloring is used to match the color of the solutions.In addition, the person analyzing the data will not know the details of the groupings.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-06-11, 1401/03/21
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.044

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
B97.21
ICD-10 code description
SARS-associated coronavirus as the cause of diseases classified elsewhere

Primary outcomes

1

Description
headache
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

2

Description
Temperatures
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Medical thermometer (Record in the checklist of symptoms)

3

Description
Cough
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

4

Description
Shortness of breath
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

5

Description
Muscular pain
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

6

Description
Sore throat
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

7

Description
Runny nose and nasal congestion
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

8

Description
Sneezing
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

9

Description
Lethargy
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

10

Description
dizziness
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

11

Description
Anorexia
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

12

Description
Diarrhea
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

13

Description
Vomit
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

14

Description
Decreased sense of taste
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

15

Description
Decreased sense of smell
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

16

Description
Skin rash
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

17

Description
Red and irritated eyes
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

18

Description
lacrimation
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

19

Description
Weakness
Timepoint
For 4 weeks, from the beginning of using mouthwash
Method of measurement
Record in the checklist of symptoms

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group 1, after preparing dark colored medicine glass bottles that are uniform, the researcher prepares 0.2% Chlorhexidine solution under the brand name Vi-one in the form of mouthwash solutions prepared from the pharmacy and only the bottle is changed. The mouthwash solution is used once in the morning and once in the evening in the amount of 15 ml for one minute. Before using mouthwash, you must use a toothbrush and eat and drink is forbidden for at least half an hour after using mouthwash. Due to the fact that some toothpastes may have antimicrobial properties, in this study, the researcher prepared plain mint toothpaste from Goltash Company and provided samples to all three groups. This toothpaste is simple and without properties. It is antimicrobial. The duration of mouthwash is two weeks, then mouthwash is stopped and personnel are followed for four weeks from the first day of mouthwash to check the onset of symptoms of Quid-19. Personnel are checked. During the four weeks that the staff is monitored, they must record and report their symptoms once a week in the symptom checklist, and if they observe any suspicious signs other than one week apart, they must Make a note of the checklist mentioned. At one-week intervals, a total of four staff members record their symptoms in a symptom checklist four times over a four-week period. The research units are asked to inform the researcher when any of the signs that have already been explained to them appear. The researcher records each of the signs that appear along with the personnel details. PCR testing will be performed on staff if required. By creating a group in WhatsApp software and daily consumption table of mouthwash, the use of mouthwash is reminded and recorded. How to use mouthwash and its important points are written on the bottles and in addition it is explained orally.
Category
Early detection

2

Description
In intervention group 2, the researcher prepares dark colored medicine glass bottles that are uniform. Sodium bicarbonate solution is prepared by the researcher as a mouthwash solution of 5.7% (per 100 ml of water containing 5.7 grams of sodium bicarbonate) using an accurate scale with Imperial brand and graduated glasses and after dissolving it , Is poured into glass bottles. The mouthwash solution is used once in the morning and once in the evening in the amount of 15 ml for one minute. Before using mouthwash, you must use a toothbrush and eat and drink is forbidden for at least half an hour after using mouthwash. Due to the fact that some toothpastes may have antimicrobial properties, in this study, the researcher prepared plain mint toothpaste from Goltash Company and provided samples to all three groups. This toothpaste is simple and without properties. It is antimicrobial. The duration of mouthwash is two weeks, then mouthwash is stopped and personnel are followed for four weeks from the first day of mouthwash to check the onset of symptoms of Quid-19. Personnel are checked. During the four weeks that the staff is monitored, they must record and report their symptoms once a week in the symptom checklist, and if they observe any suspicious signs other than one week apart, they must Make a note of the checklist mentioned. At one-week intervals, a total of four staff members record their symptoms in a symptom checklist four times over a four-week period. The research units are asked to inform the researcher when any of the signs that have already been explained to them appear. The researcher records each of the signs that appear along with the personnel details. PCR testing will be performed on staff if required. By creating a group in WhatsApp software and daily consumption table of mouthwash, the use of mouthwash is reminded and recorded. How to use mouthwash and its important points are written on the bottles and in addition it is explained orally.
Category
Early detection

3

Description
Control group: Control group: The third mouthwash of the study is a placebo. In this study, purified water is considered. Due to the use of piped drinking water in the preparation of sodium bicarbonate solution, for the placebo, purified drinking water is also piped. Used. According to the rules of placebo, in order for these three solutions to be the same shape and not to cause a problem in blinding, and according to the fact that the Chlorhexidine solution prepared is blue, the researcher added a food coloring of blue liquid which is soluble in water. It uses a small amount of the other two mouthwashes, purified water and sodium bicarbonate. The permissible oral color of the liquid is added with a dropper and in a certain volume of the mouthwash solution and compared with the Chlorhexidine solution to make them look similar in color. The mouthwash solution is used once in the morning and once in the evening in the amount of 15 ml for one minute. Before using mouthwash, you must use a toothbrush and eat and drink is forbidden for at least half an hour after using mouthwash. Due to the fact that some toothpastes may have antimicrobial properties, in this study, the researcher prepared plain mint toothpaste from Goltash Company and provided samples to all three groups. This toothpaste is simple and without properties. It is antimicrobial. The duration of mouthwash is two weeks, then mouthwash is stopped and personnel are followed for four weeks from the first day of mouthwash to check the onset of symptoms of Quid-19. Personnel are checked. During the four weeks that the staff is monitored, they must record and report their symptoms once a week in the symptom checklist, and if they observe any suspicious signs other than one week apart, they must Make a note of the checklist mentioned. At one-week intervals, a total of four staff members record their symptoms in a symptom checklist four times over a four-week period. The research units are asked to inform the researcher when any of the signs that have already been explained to them appear. The researcher records each of the signs that appear along with the personnel details. PCR testing will be performed on staff if required. By creating a group in WhatsApp software and daily consumption table of mouthwash, the use of mouthwash is reminded and recorded. How to use mouthwash and its important points are written on the bottles and in addition it is explained orally.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Afsaneh Aminbitaraf
Street address
Al-Zahra University Hospital, Soffeh Blvd, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 7516
Email
haniehkarami@nm.mui.ac.ir

2

Recruitment center
Name of recruitment center
Ayatollah Kashani hospital
Full name of responsible person
Farhad Jalali
Street address
Ayatollah Kashani Hospital, Kashani St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3792 7516
Email
haniehkarami@nm.mui.ac.ir

3

Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Maryam Azari Poor
Street address
Amin Hospital, Ebn-e-Sina St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3792 7516
Email
haniehkarami@nm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
siavash@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hanieh Karami Chamgordani
Position
Master student of Surgical technology
Latest degree
Bachelor
Other areas of specialty/work
Surgical technology
Street address
Faculty of Nursing and Midwifery ,Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7516
Email
haniehkarami@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Akram Aarabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7516
Email
aarabi@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hanieh Karami Chamgordani
Position
Master student of Surgical technology
Latest degree
Bachelor
Other areas of specialty/work
Surgical technology
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7516
Email
haniehkarami72@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Once the individuals are unidentifiable, all data will be published, including information about the main outcome as well as contextual variables such as the age and sex of the study participants.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working at academic institutions will have access to the data.
Under which criteria data/document could be used
Use of data for 1. Therapeutic 2. Research purposes
From where data/document is obtainable
Hanieh Karami Chamgordani haniehkarami@nm.mui.ac.ir
What processes are involved for a request to access data/document
Send a request by contact and provide evidence for use in research or treatment and receive data
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