Investigating the effect of tranexamic acid in preventing dry socket syndrome following surgical extraction of the impacted third molar of the mandible
The effectiveness of the use of tranexamic acid in preventing the occurrence of dry cavity after mandibular third molar surgery.
Design
A parallel group clinical trial with case and control in one person in a split mouth, single blind, randomized, phase 3 on 72 patients. The randomization tool is a sealed envelope with a random sequence
Settings and conduct
study is a clinical research (randomized controlled trial).
Research data are collected from clinical trial findings in patients referred to maxillofacial surgery department of Azad Islamic Faculty of Dentistry in Tehran in academic year 1401-1402. Tranexamic acid drug used is 250 mg capsule powder. On the side of the intervention, wash area and the cavity are filled with tranexamic acid capsule powder and sutured. then a sterile gauze is placed in the area for 30 min. On the control side, a sterile gauze is placed in place without using any local coagulant. Unilateral blinding and The person is the evaluator.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 35 years, lower mandibular third molar teeth, partially embedded, bilaterally,
exclusion criteria: no blood diseases such as anemia, thalassemia, and hemophilia, no contraindications for the administration of corticosteroids
Intervention groups
All patients undergo wisdom tooth extraction surgery by one person. The tranexamic acid used is in the form of 250 mg capsule powder. On the intervention side, the area is washed and the cavity is filled with tranexamic acid capsule powder and sutured, and then a sterile gauze is placed in the area for 30 min . On the control side, a sterile gauze is placed in place without using any local coagulant
Main outcome variables
Occurrence of dry socket phenomenon
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230603058370N1
Registration date:2023-06-20, 1402/03/30
Registration timing:registered_while_recruiting
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
Javad Nosrati Moomvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2233 0330
Email address
j.nostari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of tranexamic acid in preventing dry socket syndrome following surgical extraction of the impacted third molar of the mandible
Public title
Investigating the effect of tranexamic acid in preventing dry socket syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 35 years
the third molar teeth of the mandible are embedded
bilateral
and placed in class I, II, III, level A, B, and C based on the classification of Paul and Gray Gori
require surgical tooth extraction.
Exclusion criteria:
Users of exogenous corticosteroids
the presence of systemic disorders
respiratory and digestive diseases
pregnant women and lactating mothers
systemic fungal infections
acute infections and active or silent tuberculosis
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
72
More than 1 sample in each individual
Number of samples in each individual:
2
The research is split mouth, and on one side of the patient's jaw, an intervention (Tranexamic acid drug) is used, and on the other side, Tranexamic acid drug is not used.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we used the restricted randomization method
randomization (block randomization type)
We will use randomization. . The size of all the blocks is equal and we are in this Single-group trial of 4 blocks (including 4 participants in
We will have an intervention group and a control). The randomization tool is also from sequence generation software
Random (random software allocation) is used that this
Random sequence generation software is capable of simple randomization
They are used to generate random sequences using the block method. To hide
We use Concealment Allocation
We use the method used to execute the sequence
Randomization is applied to the participants in the study, in a way
Before assigning the individual, the assigned group is not clear. With
from sealed opaque envelopes with random sequence
(envelopes opaque, sealed, numbered Sequentially (which in
In this method, each random sequence is created on a card
It is registered and the cards are placed in the envelopes in order
become In order to preserve the random sequence on the outer surface of the envelope
Numbering is done in the same order. Finally, the envelope door
The letters are glued and placed in a box in order. At
The time of starting the registration of participants, based on the order of entry of the company
Eligible candidates to study, one of the letter envelopes in open order
and the assigned group of that participant is revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator does not know the type of intervention and the study is conducted in a single blind manner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Dentistry Faculty - Islamic Azad University of Medical Sciences, Tehran
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2022-12-05, 1401/09/14
Ethics committee reference number
IR.IAU.DENTAL.REC.1401.097
Health conditions studied
1
Description of health condition studied
Dry socket
ICD-10 code
M27
ICD-10 code description
Other diseases of jaws
Primary outcomes
1
Description
Occurrence or absence of dry socket syndrome
Timepoint
Two or three days after surgery on both intervention and control sides
Method of measurement
Evaluation through clinical observation by maxillofacial surgeon
Secondary outcomes
empty
Intervention groups
1
Description
All patients undergo wisdom tooth extraction surgery by one person. The type of cut in all operations is similar and buccal flap type with distobuccal releasing, along with sulcular cut to the mesial of tooth seven. After giving anesthesia, making a cut, and setting aside the flap, some of the bone covering the tooth will be removed with a surgical burr, and after sectioning the tooth and removing it, on the side of the intervention area, wash the cavity with tranexamic acid 250 mg capsule powder. Iran Daro is filled, then it is stitched using 0.3 chromic thread and 26 mm needle.And then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of infection, amoxicillin 250 mg capsules will be prescribed every 8 hours for all patients, and Gelofen 500 mg tablets will be prescribed every 6 hours for possible pain control. The patient is asked to do the following in the first 24 to 48 hours: 1- Use cold and liquid food such as: cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not eat hot or chewy food in any way. 3- Avoid brushing the area of the extracted tooth. 4- Avoid smoking and do not spit out your saliva in any way. 5- Avoid stimulating the area of the extracted tooth with hand or tongue. 6- Avoid heavy sports and physical work and give priority to rest. • After one day of surgery, normal saline solution at least five times a day for one It should be used as a mouthwash for a week. Two or three days after the extraction of the impacted third molar tooth, the visit time for the clinical examination of the dry cavity or the absence of a dry cavity is determined for the patient, and the examination is performed by another maxillofacial surgeon and the symptoms of the posterior cavity Clinical examination will be recorded
Category
Prevention
2
Description
Control group: On the control side, all the patients were subjected to surgery to remove the mandibular wisdom teeth by one person. The type of cut in all operations is similar and buccal flap type with distobuccal releasing, along with sulcular cut to the mesial of tooth seven. After giving anesthesia, making the incision, and setting aside the flap, some of the bone covering the tooth will be removed with a surgical burr, and after sectioning the tooth and removing it, on the control side of the washing area and the cavity without using any local coagulant with Using a 0.3 chromic thread and a 26 mm needle, stitches are made, and then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of infection, amoxicillin 250 mg capsules will be prescribed every 8 hours for all patients, and Gelofen 500 mg tablets will be prescribed every 6 hours for possible pain control. The patient is asked to do the following in the first 24 to 48 hours: 1- Use cold and liquid food such as: cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not eat hot or chewy food in any way. 3- Avoid brushing the area of the extracted tooth. 4- Avoid smoking and do not spit out your saliva in any way. 5- Avoid stimulating the area of the extracted tooth with hand or tongue. 6- Avoid heavy sports and physical work and give priority to rest. • After one day of surgery, normal saline solution at least five times a day for one It should be used as a mouthwash for a week. Two or three days after the extraction of the impacted third molar tooth, the visit time for the clinical examination of the dry cavity or the absence of a dry cavity is determined for the patient, and the examination is performed by another maxillofacial surgeon and the symptoms of the posterior cavity Clinical examination will be recorded
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Medical Sciences - Faculty of Dentistry, Tehran branch
Full name of responsible person
Hassan Mesgari
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
kmesgari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Mesgari
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
kmesgari@gmail.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
Hassan Mesgari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
kmesgari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Mesgari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
kmesgari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Mesgari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
kmesgari@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
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