Efficacy of professional oral health care (POHC) and chlorhexidine and% 0/2 povidon Iodine mouth rinse on survival rate and clinical characteristics of patients with Covid-19
Efficacy of professional oral health care (POHC) and chlorhexidine and0/2 % povidon Iodine mouth rinse on survival rate and clinical and paraclinical characteristics of patients with Covid19
Design
Two arm parallel group randomised trial with block randomization on 200 patients
Settings and conduct
A clinical trial will be performed on 200 patients suspected of having 19 patients admitted to Taleghani Hospital in Ahvaz and Shaheed Beheshti in Kashan .Patients are examined for oral health then will divide to 4 groups according on Oral Health Scale: Good, Moderate ,Poor,Fair .Regarding oral health they will divide into two groups :healthy (patient with good and moderate scale ) and Unhealthy (patient with poor and fair scale) . Patients are then randomly divided into two groups: training intervention and use of chlorhexidine and Betadine mouthwash) and control group.
Participants/Inclusion and exclusion criteria
Include criteria:
1. possibility of involving to Covid-19
2. PaO2/FiO2 < 300 mm Hg or SpO2 < 93% in air ambient or need to Oxygen supplementary for SpO2 to 94-98% or lung infiltration >50%
3.consciousnesses of patient and be able to complete letter satisfaction
Exclude criteria:
1.Pregnancy
2.Allergy to mouth rinse
3.Immunodeficiency such as : Sever combined immuno deficiency and HIV
4. Immuno suppressant Drugs consumer such as : transplantation recipient patient
5.Dissatisfaction with participating in the study
Intervention groups
education of professional oral health care (POHC) and chlorhexidine and0/2 % povidon Iodine mouth rinse for intervention group and recommendation of routine oral hygiene for control group
Efficacy of professional oral health care (POHC) and chlorhexidine and% 0/2 povidon Iodine mouth rinse on survival rate and clinical characteristics of patients with Covid-19
Public title
Effect of oral health care and mouth rinse in treatment of 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
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization / random allocation on 200 patients with covid 19
Thus, in each of the intervention 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
2020-05-06, 1399/02/17
Ethics committee reference number
IR.KAUMS.REC.1399.015
Health conditions studied
1
Description of health condition studied
SARS-CoV-2 َassociated SARI
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
mortality status
Timepoint
28 days after admit day
Method of measurement
percent (live/ dead)
3
Description
Xerostomia
Timepoint
Daily during first day of hospitalization until 28 days
Method of measurement
percent (has/has not)
4
Description
Change of Taste sens
Timepoint
Daily during first day of hospitalization until 28 days
Method of measurement
percent (has/has not)
5
Description
New oral erythematous lesion
Timepoint
Daily during first day of hospitalization until 28 days
Method of measurement
percent (has/has not)
6
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 decilitre
3
Description
para clinical outcome (blood magnesium)
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per decilitre
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 decilitre
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 decilitre
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
millimetre 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 decilitre
13
Description
para clinical outcome (blood nutriome)
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per decilitre
14
Description
para clinical outcome (Blood glucose)
Timepoint
The first day and the last day of discharge
Method of measurement
milligrams per decilitre
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
millimetre
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
femtolitre
22
Description
para clinic outcome(hemoglobin)
Timepoint
The first day and the last day of discharge
Method of measurement
grams per decilitre
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: .............
Category
Prevention
2
Description
Control group: .......
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Beheshti Hospital
Full name of responsible person
Dr.Mohammad Reza Sharif
Street address
Gotbe Ravandi
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
beheshtihospital@kaums.ac.ir
2
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Soltan Ali Bahmani
Street address
Phase 2 of Padadshahr, in front of the police station 23
City
Khuzestan
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3554 0255
Email
Ahlam.tor.95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotb Ravandi
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?
Yes
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
Ghotb Ravandi
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 GhasemzadehHosseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghotb Ravandi
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 GhasemzadehHosseini
Position
استادیار
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghotb Ravandi
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