Comparison of the effect of aspirin use and non-use of bleeding after tooth extraction in dental school
Tehran Islamic Azad University of Medical Sciences, in 1400
Design
This study is performed by designing a clinical trial of two blinded with 40 samples
Settings and conduct
This study is performed in the School of Dentistry of Tehran Azad University.
Three stages of hemostatic assessment and bleeding management scale are presented as normal, moderate, and severe
Is. After extracting the tooth, a gauze is placed in the extracted tooth for 10 minutes.
The desired area is examined.
Bleeding that stops within 10 minutes or less is considered normal.
Bleeding that stops within 30 minutes or less is considered moderate.
Bleeding that lasts more than 30 minutes and using a collagen sponge, suture, or gauze soaked in
Tranexamic acid (transamine 10, 250% mg / 2.5 ml) should be considered as severe
It is taken and at the end the bleeding time is recorded.
Participants/Inclusion and exclusion criteria
Consumer patients
Aspirin (80 mg per day) and patients without aspirin who need extraction of teeth 6 and 7
(Molar teeth) and are in the age range of 18 to 60 years will be selected for inclusion in the study.
Patients with a history of thrombocytopenia, alcohol and drug addiction, taking other anticoagulants,
Kidney and liver dysfunction, patients receiving nonsteroidal anti-inflammatory drugs; Periodontal disease
Teeth and patients who need to have their teeth surgically removed are excluded
Intervention groups
Patients are divided into two groups. In group A, 20 patients are studied who are taking aspirin
And in group B, another 20 patients who do not take aspirin are assigned
Main outcome variables
The amount of bleeding in the area of tooth extraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210404050844N1
Registration date:2021-06-03, 1400/03/13
Registration timing:registered_while_recruiting
Last update:2021-06-03, 1400/03/13
Update count:0
Registration date
2021-06-03, 1400/03/13
Registrant information
Name
Fina Navi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 1657
Email address
fina-navi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aspirin on bleeding after tooth extraction
Public title
The effect of Aspirin on bleeding of tooth
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who use to Aspirin80mg/day
Patients without use Aspirin
Patients who need to extract teeth 6 or 7
Exclusion criteria:
Thrombocytopenia
Alcohol and drug addiction
Consumer of other anticoagulants
Kidney and liver dysfunction
Patients receiving nonsteroidal anti-inflammatory drugs
Periodontal tooth disease
Patients need to have their teeth extracted surgically
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
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 the School of Dentistry - Islamic Azad University of Medical Sciences, Tehran
Street address
Psadaran Av, neyestan9, dental school
City
Tehran
Province
Tehran
Postal code
6764897653
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.304
Health conditions studied
1
Description of health condition studied
Tooth bleeding rate
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people with bleeding for more than 30 minutes
Timepoint
Measure bleeding in less than 10 minutes. Less than 30 minutes and more than 30 minutes
Method of measurement
View
Secondary outcomes
empty
Intervention groups
1
Description
The controller and the patient will be blind to the study groups. In case groups, local anesthesia is first performed by injecting Carpol 1.8 cc, containing 3% mp and cocaine.(2.7 to 3.6 cc of MPa and Vaccaine are injected into all patients) and then the tooth is removed in place with the help of forceps and alveolar in a standard way. . After extracting the tooth, a gauze is placed in the extracted tooth for 10 minutesوThe desired area is examined. Bleeding that stops within 10 minutes or less is considered normal. Bleeding that stops within 30 minutes or less is considered moderate. Bleeding that lasts more than 30 minutes and using a collagen sponge, suture, or gas pressure soaked in tranexamic acid (10% transamine, 250 mg / 2.5 Ml) is considered as severe and at the end the bleeding time is recorded.
Category
Treatment - Drugs
2
Description
Control group: The controller and the patient will be blind to the study groups. In control groups, local anesthesia is first performed by injecting Carpol 1.8 cc, containing 3% mp and cocaine.(2.7 to 3.6 cc of MPa and Vaccaine are injected into all patients) and then the tooth is removed in place with the help of forceps and alveolar in a standard way. . After extracting the tooth, a gauze is placed in the extracted tooth for 10 minutesوThe desired area is examined. Bleeding that stops within 10 minutes or less is considered normal. Bleeding that stops within 30 minutes or less is considered moderate. Bleeding that lasts more than 30 minutes and using a collagen sponge, suture, or gas pressure soaked in tranexamic acid (10% transamine, 250 mg / 2.5 Ml) is considered as severe and at the end the bleeding time is recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Azad University of Tehran
Full name of responsible person
Fina Navi
Street address
Pasdaran Av, Neyestan9
City
Tehran
Province
Tehran
Postal code
7685436789
Phone
+98 21 2256 4571
Email
dr.zahra.mirgonjani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Mirgonjani
Street address
Pasdaran, Neyestan9, dental school
City
Tehran
Province
Tehran
Postal code
5467896543
Phone
+98 21 2256 4571
Email
dr.zahra.mirgonjani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
not
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fina Navi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Av , Neyestan9, dental school
City
Tehran
Province
Tehran
Postal code
1698749511
Phone
+98 21 6641 1657
Email
FINA-NAVI@YAHOO.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fina Navi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Av, Neyestan9, dental school
City
Tehran
Province
Tehran
Postal code
1698749511
Phone
+98 21 6641 1657
Email
FINA-NAVI@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fina Navi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Psadaran, Neyestan9, dental school
City
Tehran
Province
Tehran
Postal code
1698749511
Phone
+98 21 6641 1657
Email
FINA-NAVI@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
all data
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
oll of people
Under which criteria data/document could be used
researcher
From where data/document is obtainable
Tehran Azad Dental School. Zahra Mirgonjani
dr.zahra.mirgonjani@gmail .com
What processes are involved for a request to access data/document