Determining the effect of using chlorhexidine 0/12% and Povidone-iodine 0.2%
mouth rinse on clinical characteristics of patients with COVID-19
Design
Randomized, parallel clinical trial, phase 2-3 with block randomization
Settings and conduct
Patients with COVID-19 who referred to Beheshti Hospital in Kashan, are examined for oral health (based on Oral health assessment scale) are divided into two groups Healthy (Good And Moderate) and Unhealthy (Poor and Bad ) and are randomly divided into four groups: intervention (treatment with chlorhexidine 0/12 %, Povidone-iodine 0.2% ,Povidone-iodine 0.2% and chlorhexidine0/12% mouthwash) and control only do routine oral hygiene (toothbrush and floss). Patient are examined daily until discharge and their clinical and paraclinical information is recorded. their laboratory and clinical data are obtained from hospital database. Length of hospitalization , condition of ventilation and duration of one month survive (by call) after discharge are recorded. If patients have oral lesions, they will be treated.
Participants/Inclusion and exclusion criteria
Inclusion criteria : possibility of involving to COVID-19; PaO2/FiO2 < 300 mm Hg or SpO2 < 93% in air ambient or need to oxygen supplementary for SpO2 in range of 94-98% or lung infiltration > 50%; consciousness of patient ; minimum 18 years old
Exclusion criteria :Pregnancy; Immunodeficiency such as patient with Severe combined immune deficiency and HIV; Allergy to mouth rinse; Immunosuppressant drug consumer such as transplantation recipient patient; Dissatisfaction with participating in the study
Intervention groups
intervention groups :treatment with chlorhexidine 0/12% and Povidone-iodine 0.2% mouth rinse , treatment with chlorhexidine 0/12% mouth rinse, treatment with Povidone-iodine 0.2% mouth rinse
Main outcome variables
Xerostomia index, oral ulcers ,mouth redness changes, changes in taste
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200527047581N2
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Elaheh Ghasemzadeh hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3389 1966
Email address
ghasemzadeh-e@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-07-11, 1400/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Chlorhexidine 0/12% and 0/2 % Povidone-iodine mouth rinse on clinical characteristics of patients with COVID-19
Public title
Efficacy of Chlorhexidine 0/12% and 0/2 % Povidone-iodine mouth rinse on clinical characteristics of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
possibility of involving to COVID-19
PaO2/FiO2 < 300 mm Hg or SpO2 < 93% in air ambient or need to oxygen supplementary for SpO2 in range of 94-98% or lung infiltration > 50%
consciousness of patient and to be able to complete letter of satisfaction
minimum 18 years old
Exclusion criteria:
Pregnancy patient
Immunodeficiency such as patient with Severe combined immune deficiency and HIV
Allergy to mouth rinse
Immunosuppressant drug consumer such as transplantation recipient
Dissatisfaction with participating in the study
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization / random allocation on 180 patients with COVID-19 Thus, in each of four groups : the intervention groups ( chlorhexidine , povidone-iodine , chlorhexidine and povidone-iodine) and control groups, 4 randomization blocks are allocated. It is worth mentioning that random sequences in the execution of 4 blocks will be performed by the researcher without using statistical software allocation concealment does not apply in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd
City
kashan
Province
Isfehan
Postal code
55578011
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.KAUMS.REC.1399.044
Health conditions studied
1
Description of health condition studied
COVID-19 associated severe respiratory syndrome
ICD-10 code
U07.1
ICD-10 code description
SARS-CoV-2
Primary outcomes
1
Description
Duration of hospitalization
Timepoint
End of study
Method of measurement
Calculation
2
Description
Xerostomia
Timepoint
Daily during first day of hospitalization until 28 days
Method of measurement
percent (has/has not)
3
Description
Change of Taste sense
Timepoint
Daily during first day of hospitalization until 28days
Method of measurement
percent (has/has not)
4
Description
New oral erythematous lesion
Timepoint
Daily during first day of hospitalization until 28 days
Method of measurement
percent (has/has not)
5
Description
new oral ulcer
Timepoint
Daily during first day of hospitalization until 28 days
Method of measurement
percent (has/has not )
Secondary outcomes
1
Description
Para clinical outcome(White blood cell count)
Timepoint
The first day and the last day of discharge
Method of measurement
cell number x 1000
2
Description
Para clinical outcome (blood potassium)
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per deciliter
3
Description
Para clinical outcome (blood magnesium)
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per deciliter
4
Description
Para clinical outcome (platelet count)
Timepoint
The first day and the last day of discharge
Method of measurement
cell number x 1000
5
Description
Para clinical outcome (C Reactive protein)
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per deciliter
6
Description
Para clinical outcome (CURB65)
Timepoint
The first day and the last day of discharge
Method of measurement
scale
7
Description
Para clinical outcome (Creatinine)
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per deciliter
8
Description
Para clinical outcome(Respiratory rate per minute)
Timepoint
The first day and the last day of discharge
Method of measurement
number of breath per minute
9
Description
Para clinical outcome(blood pressure)
Timepoint
The first day and the last day of discharge
Method of measurement
millimeter of mercury
10
Description
Para clinical outcome(Body temperature)
Timepoint
The first day and the last day of discharge
Method of measurement
centigrade
11
Description
Para clinical outcome (heart rate per minute)
Timepoint
The first day and the last day of discharge
Method of measurement
beats per minute
12
Description
Para clinical outcome (Blood Urea nitrogen)
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per deciliter
13
Description
Para clinical outcome (blood sodium )
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per deciliter
14
Description
Para clinical outcome (Blood glucose)
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per deciliter
15
Description
para clinical outcome (Hematocrit)
Timepoint
The first day and the last day of discharge
Method of measurement
percentage
16
Description
Para clinical outcome (Oxygen saturation)
Timepoint
The first day and the last day of discharge
Method of measurement
percentage
17
Description
para clinic outcome (erythrocyte sedimentation rate)
Timepoint
The first day and the last day of discharge
Method of measurement
millimeter
18
Description
Para clinic outcome (CT)
Timepoint
The first day
Method of measurement
number of focal of lung involvement
19
Description
Para clinic outcome (neutrophil)
Timepoint
The first day and the last day of discharge
Method of measurement
cell number x 1000
20
Description
Para clinic outcome (lymphocyte)
Timepoint
The first day and the last day of discharge
Method of measurement
cell number x 1000
21
Description
Para clinic outcome(mean corpuscular volume)
Timepoint
The first day and the last day of discharge
Method of measurement
femtoliter
22
Description
Para clinic outcome (hemoglobin)
Timepoint
The first day and the last day of discharge
Method of measurement
grams per deciliter
23
Description
para clinic outcome (AST)
Timepoint
The first day and the last day of discharge
Method of measurement
units per liter
24
Description
Para clinic outcome (ALT)
Timepoint
The first day and the last day of discharge
Method of measurement
units per liter
25
Description
Para clinic outcome (ALP)
Timepoint
The first day and the last day of discharge
Method of measurement
units per liter
Intervention groups
1
Description
Intervention group: patients with a probable diagnosis of COVID-19 will receive oral health care training by a nurse, including: tooth and tongue brush, cleaning dentures in people with dentures. Rinse chlorhexidine 0.12% mouthwash every 12 hours for one minute and Povidone-iodine 2% mouthwash every 6 hours 4 times a day for 2 minutes.
Category
Treatment - Drugs
2
Description
Intervention group: patients with a probable diagnosis of COVID-19 will receive oral health care training by a nurse, including: tooth and tongue brush, cleaning dentures in people with dentures. Rinse chlorhexidine 0.12% mouthwash every 12 hours for one minute.
Category
Treatment - Drugs
3
Description
Intervention group: patients with a probable diagnosis of COVID-19 will receive oral health care training by a nurse, including: tooth and tongue brush, cleaning dentures in people with dentures. Rinse Povidone-iodine 2% mouthwash every 6 hours 4 times a day for 2 minutes.
Category
Treatment - Drugs
4
Description
Control group: patients with a probable diagnosis of COVID-19 will receive oral health care training by a nurse, including: tooth and tongue brush, cleaning dentures in people with dentures.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr.Mohammad Reza Sharif
Street address
Gotbe Ravandi Blvd.
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotbe Ravandi Blvd.
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Elaheh GhasemzadehHosseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghotbe Ravandi Blvd.
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 8840
Email
dr.el.ghasemzade@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Elaheh Ghasemzadeh Hosseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghotbe Ravandi Blvd.
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 8840
Email
dr.el.ghasemzade@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Elaheh Ghasemzadeh Hosseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghotbe Ravandi Blvd.
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 8840
Email
dr.el.ghasemzade@gmail.com
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