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Comprasion of the Effect of dilute hydrogen peroxide and tranexamic acid with local application of gas on control of bleeding after tooth extraction in patients using asprin

Protocol summary

Study aim
Comparison of bleeding control status after tooth extraction after local use of gases impregnated with diluted hydrogen peroxide and gases impregnated with tranexamic acid
Design
A clinical trial with a control group, with parallel groups, double-blind, non-randomize ,phase 3 on 24 patients
Settings and conduct
The place of study is Alborz School of Dentistry. For patients, three maxillary teeth are extracted. And the patients' teeth are evaluated in the following three groups: After entering, the patients' teeth are randomly divided into the desired groups, including the local application of gas impregnated with diluted hydrogen peroxide and tranexamic acid, as well as the control group. Each group is examined by the surgeon and the patient himself for the type of medicine used in 0 and 15 minutes. They will not know
Participants/Inclusion and exclusion criteria
Inclusion criteria Teeth with deep decay and teeth that are extracted due to periodontal reasons are removed non-surgically Exit criteria Patients with systemic diseases Patients using aspirin more than 80 mg
Intervention groups
For patients, three maxillary teeth are extracted. And the patients' teeth are evaluated in the following three groups: After entering, the patients' teeth were randomly divided into the desired groups, including the local application of gas impregnated with diluted hydrogen peroxide and tranexamic acid, as well as the control group. In the first group, gas impregnated with hydrogen peroxide, in the second group, gas impregnated with tragrammic acid, and in the control group, gas without coagulant is placed, and each group keeps the gas in place for 10 and 15 minutes.
Main outcome variables
Investigating the effectiveness of gases impregnated with diluted hydrogen peroxide and tranexamic acid in bleeding control and its clinical application on aspirin consuming patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230828059283N1
Registration date: 2023-08-29, 1402/06/07
Registration timing: prospective

Last update: 2023-08-29, 1402/06/07
Update count: 0
Registration date
2023-08-29, 1402/06/07
Registrant information
Name
RAZIYEH Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 990 626 1634
Email address
sarataheri196@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprasion of the Effect of dilute hydrogen peroxide and tranexamic acid with local application of gas on control of bleeding after tooth extraction in patients using asprin
Public title
Investigating the effectiveness of gases impregnated with diluted hydrogen peroxide and tranexamic acid in bleeding control and its clinical application on aspirin consuming patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Teeth with deep decay and teeth that are extracted due to periodontal reasons and removed non-surgically. Patients without other systemic diseases and non-smokers.
Exclusion criteria:
Patients with systemic diseases and the use of anticoagulant drugs except aspirin and smokers, teeth with periodontal problems and the need for open surgery during treatment. Unknown internal coagulation disorders factors Qualitative and quantitative platelet problems Taking other anticoagulant drugs by the patient History of hemophilia Patients using aspirin more than 80 mg
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 24
More than 1 sample in each individual
Number of samples in each individual: 3
For the examined patients, three maxillary teeth are extracted
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The surgeon and the patient will not know the type of medicine used.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Safarian Alley, 45 meters from Golshahr, Karaj
City
karaj
Province
Alborz
Postal code
319876465
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.ABZUMS.REC.1402.143

Health conditions studied

1

Description of health condition studied
Comprasion of the effect of dilute hydrogen peroxide and tranexamic acid with local application of gas on control of bleeding after tooth extraction in patients using asprin
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Active bleeding:Bleeding refers to bleeding that does not form a clot after a period of 2 to 9 minutes and is continuous
Timepoint
10 to 15 minute
Method of measurement
Clinical examinations

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the desired group 1, two gauzes soaked in 10 ml of diluted hydrogen peroxide solution (1%) prepared by the pharmacy technician (by adding 3.3 ml of water with 6.6 ml of 1.5% hydrogen peroxide) is kept in place for10 and 15 minutes immediately after tooth extraction
Category
Treatment - Drugs

2

Description
Intervention group: In the target group 2, two gauzes impregnated with tranexamic acid solution after tooth extraction in the form of 10 ml tranexamic acid solution and two ampoules of tranexamic acid 50 mg/5 ml with a concentration of 4.8% immediately after tooth extraction for It is kept in place for 10 to 15 minutes
Category
Treatment - Drugs

3

Description
Control group: control group: . In the control group, after tooth extraction, without using any local coagulant, the patient is asked to keep the two gauzes in place for 10 and 15 minutes using two sterile gauzes.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Alborz University of Medical Sciences
Full name of responsible person
RAZIYEH Taheri
Street address
Shahid Katoiizade St,45 meters, Golshahr, Karaj
City
karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3353 1614
Email
dentalclinic@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
RAZIYEH Taheri
Street address
Shahid Katoiizade St, 45 meters Golshahr, Karaj
City
karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3353 1614
Email
dentalclinic@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The cost is covered by the student
Proportion provided by this source
100
Public or private sector
Private
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
Karaj University of Medical Sciences
Full name of responsible person
RAZIYEH Taheri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahid Katoiizade St, 45 meters Golshahr, Karaj
City
karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3350 0080
Email
sarataheri196@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
RAZIYEH Taheri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahid Katoiizade St, 45 meters Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3355 5049
Email
sarataher196@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
RAZIYEH Taheri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahid Katoiizade St, 45 meters Golshahr, Karaj
City
karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3350 0080
Email
sarataheri196@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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