Comparison of the effect of tranexamic acid washing solution with gel foam impregnated with tranexamic acid (TXA) on the amount of bleeding time after wisdom tooth surgery in all healthy patients between 20 and 60 years old who require bilateral extraction of mandibular wisdom teeth
Determining the comparison of the effect of using a washing solution containing tranexamic acid with Gelfoam impregnated with tranexamic acid (TXA) on the amount of bleeding after wisdom tooth surgery.
Design
A clinical trial without a control group with parallel groups, randomized with randomization website, with a sample size of 42 healthy patients between 20 and 60 years old.
Settings and conduct
wisdom tooth surgery on one side of the mandible and silent tooth washing using tranexamic acid solution (10 cc 150 mg), then suturing and measuring the bleeding time (we put sterile gauze every one minute until its color turns pink and go down)
Then wisdom tooth surgery on the other side and placing Gelfoam impregnated with tranexamic acid (10 cc 150 mg), then suturing and measuring the bleeding time (we put sterile gauze every one minute until the color turns pink and decreases) and Finally, these two methods are compared.On the 3rd, 7th, and 14th days after surgery, patients are examined for pain
All samplings are done in the clinic of Jundishapur Dental School in Ahvaz
Participants/Inclusion and exclusion criteria
Healthy patients between 20 and 60 years old who have bilateral mandibular wisdom teeth
Intervention groups
First intervention: wisdom tooth surgery on one side of the mandible and silent tooth washing using a washing solution containing tranexamic acid (10 cc 150 mg) and measuring the bleeding time The second intervention: surgery on the opposite tooth of the same person and placing Gelfoam impregnated with tranexamic acid (10 cc 150 mg) and measuring the bleeding time
Main outcome variables
Bleeding time after wisdom tooth surgery
Pain after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231127060206N1
Registration date:2023-12-05, 1402/09/14
Registration timing:prospective
Last update:2023-12-05, 1402/09/14
Update count:0
Registration date
2023-12-05, 1402/09/14
Registrant information
Name
Arsalan Saki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 6215
Email address
sakiarsalan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-08, 1402/09/17
Expected recruitment end date
2023-12-28, 1402/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of tranexamic acid washing solution with gel foam impregnated with tranexamic acid (TXA) on the amount of bleeding time after wisdom tooth surgery in all healthy patients between 20 and 60 years old who require bilateral extraction of mandibular wisdom teeth
Public title
Comparison of the effect of tranexamic acid washing solution with gel foam impregnated with tranexamic acid (TXA) on the amount of bleeding time after wisdom tooth surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
all healthy patients between 20 and 60 years old
With bilateral mandibular wisdom teeth
Exclusion criteria:
Patients with underlying problems and diseases
Patients with coagulation problems
Non-committed and uncooperative patients
Physically and mentally disabled patients
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
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 Jundi Shapur Ahvaz University of Medical Sciences
Street address
Faculty of dentistry , jundishapur university of medical science , esfand st , Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.AJUMS.REC.1402.443
Health conditions studied
1
Description of health condition studied
Measuring the bleeding time after wisdom tooth surgery after using tranexamic acid in solution form and gelfoam impregnated with tranexamic acid in two separate sockets of mandibular wisdom teeth and comparing these two methods at the end and also measuring pain on days 3, 7 and 14 From surgeryCommunity Verified icon
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
bleeding time
Timepoint
Every minute after the intervention
Method of measurement
Using sterile gas and changing the color and amount of blood on it after every minute
Secondary outcomes
1
Description
Measurement of pain after surgery
Timepoint
Day 3, 7 and 14 after surgery
Method of measurement
using visual analogue scale
Intervention groups
1
Description
Intervention group: In all healthy patients between 20 and 60 years old. Washing one of the sockets of the mandibular wisdom tooth after tooth extraction using a washing solution containing tranexamic acid (10 cc 150 mg). Placing gelfoam impregnated with tranexamic acid (150 mg) in another socket after tooth extraction.
Category
Prevention
2
Description
Intervention group: Intervention group: Gelfoam impregnated with tranexamic acid (10 cc 150 mg) is placed in the same patient as before and in another patient.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University Dental Clinic
Full name of responsible person
Mahdis Masoudrad
Street address
faculty of dentistry clinic , Ahvaz jundishapour university of medical sciences , esfand st , golestan , Ahvaz , Khoozestan , Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
fdentistry@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsid Masoudrad
Street address
faculty of dentistry clinic , Ahvaz jundishapour university of medical sciences , esfand st , golestan , Ahvaz , Khoozestan , Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
fdentistry@ajums.ac.ir
Grant name
Vice Chancellor for Research, Research and Technology, Jundishapur University of Medical Sciences, AhvazCommunity Verified icon
Grant code / Reference number
گرنت استفاده نشده است
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Arsalan Saki
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry , jundishapur university of medical science , esfand st , Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
sakiarsalan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahdis Masoudrad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry , jundishapur university of medical science , esfand st , Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
masoudrad.m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arsalan Saki
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry , jundishapur university of medical science , esfand st , Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
sakiarsalan@gmail.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 is shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
All interested people in various related fields can apply to receive them
Under which criteria data/document could be used
The analyzes that are going to be done have been done in line with the research
From where data/document is obtainable
By e-mail
sakiarsalan@gmail.com
What processes are involved for a request to access data/document
Someone who is an expert and interested, along with a document, send a request via electronic mail, explaining the reason for the need for the data and what is to be done on the data, and the reason for the interest.