Protocol summary

Study aim
Evaluation of serum oxygen level after using five-layer ,three-layer and n95 face masks after 1, 2 and 3 hours in dental students
Design
This cross-sectional analytical study was performed on 38 dental students of Islamic Azad University in 1401-1400 will be. Students will enter the study based on entry and exit criteria. Age and gender of students Will be registered
Settings and conduct
This cross-sectional study will be performed on 38 dental students of Islamic Azad University in 2021-2022. Students will enter the study based on entry and exit criteria. Students' age and gender will be recorded. Their arterial oxygen percentage will be measured 22 minutes before the start of the study and at rest using a pulse oximeter, Datascope (Passport 2), USA. The pulse oximeter shows the average pulse oximeter every five seconds. Pulse oximeter probe to the finger that makes the best wave Will be connected. The finger should be clean and free of henna, paint or tattoos and should not be cold. This study will be done in three days.
Participants/Inclusion and exclusion criteria
Entry Conditions : Complete health and satisfaction in the study No entry conditions: Heart, respiratory, kidney disease and smoking
Intervention groups
Control group: Evaluation of blood serum oxygen before usage of 3-layer, 5-layer and N95 face mask . Intervention group 1: Students are asked to put a three-layer mask on their face. After 1, 2 and 3 hours, their arterial oxygen level will be measured. Intervention group 2: Students are asked to put a five-layer mask on their face. After 1, 2 and 3 hours, their arterial oxygen level will be measured. Intervention group 3: Students are asked to put a N95 mask on their face. After 1, 2 and 3 hours, their arterial oxygen level will be measured.
Main outcome variables
Evaluation of blood serum oxygen before usage and then after 1, 2 and 3 hours usage of face mask.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211021052832N1
Registration date: 2021-11-16, 1400/08/25
Registration timing: registered_while_recruiting

Last update: 2021-11-16, 1400/08/25
Update count: 0
Registration date
2021-11-16, 1400/08/25
Registrant information
Name
Ebrahim Fakouri joybari
Name of organization / entity
Azad tehran dental university
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 9758
Email address
ebi.fakouri1987@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-07, 1400/08/16
Expected recruitment end date
2021-11-19, 1400/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of serum oxygen level following the use of three-layer, five-layer and n95 masks after intervals of 1,2,3 hours in dental students
Public title
The effect of the mask on blood oxygen
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Complete health satisfaction in the study
Exclusion criteria:
Heart, respiratory, kidney disease, smoking
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the School of Dentistry, Islamic Azad University of Medical Sciences
Street address
No. 9, Neyestan 9th alley, Pasdaran Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.081

Health conditions studied

1

Description of health condition studied
Blood serum oxygen level changes after using face masks.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood serum oxygen level before usage of 3-layers, 5-layers and N95 face masks.
Timepoint
Before usage of 3-layers, 5-layers and N95 face masks.
Method of measurement
Pulse oximetry

2

Description
Blood serum oxygen level after 1 hour usage of 3-layers, 5-layers and N95 face masks.
Timepoint
After usage of 3-layers, 5-layers and N95 face masks for 1 hour.
Method of measurement
Pulse oximetry

3

Description
Blood serum oxygen level after 2 hours usage of 3-layers, 5-layers and N95 face masks.
Timepoint
After usage of 3-layers, 5-layers and N95 face masks for 2 hour.
Method of measurement
Pulse oximetry

4

Description
Blood serum oxygen level after 3 hours usage of 3-layers, 5-layers and N95 face masks.
Timepoint
After usage of 3-layers, 5-layers and N95 face masks for 3 hour.
Method of measurement
Pulse oximetry

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Control group 1: Blood Serum oxygen level in students is measured before applying the face mask.
Category
N/A

2

Description
Intervention group 1: Students are asked to put a three-layer mask (Rainik, Iran) on their face. After 1, 2 and 3 hours, their arterial oxygen level will be measured by pulse oximeter. In the meantime, the mask will not be removed from the students' faces.
Category
Prevention

3

Description
Intervention group2 : Students are asked to put a Five-layer mask (Rainik, Iran) on their face. After 1, 2 and 3 hours, their arterial oxygen level will be measured by pulse oximeter. In the meantime, the mask will not be removed from the students' faces.
Category
Prevention

4

Description
Intervention group 3: Students are asked to put a N95 mask (Mellat Bloon, Iran) on their face. After 1, 2 and 3 hours, their arterial oxygen level will be measured by pulse oximeter. In the meantime, the mask will not be removed from the students' faces.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive treatment department of the dental school
Full name of responsible person
Ebrahim fakouri juibary
Street address
No. 9, Neyestan 9th alley, Pasdaran Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Ebi.fakouri1987@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ebrahim Fakouri Jouybari
Street address
No. 9, Neyestan 9th alley, Pasdaran Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1946852214
Phone
+98 21 2256 4571
Email
ebi.fakouri1987@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Ebi Fakouri Jouybari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, Neyestan 9th alley, Pasdaran Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
ebi.fakouri1987@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Makkinejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Neyestan 9th alley, Pasdaran Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1946853315
Phone
+98 21 2256 4571
Email
amackinejad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Makinejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Neyestan 9th alley, Pasdaran Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
amackinejad@yahoo.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
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
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