Comparison between the effect of foam gel impregnated with dexamethasone and tranexamic acid on swelling, bleeding and pain after mandibular wisdom teeth surgery
Comparison between the effect of gelfoam impregnated with dexamethasone and tranexamic acid on swelling, bleeding and pain after mandibular wisdom teeth surgery
Design
Clinical trial with two intervention groups with one-sided blind parallel groups with phase 3 randomized table on 58 patients
Settings and conduct
58 patients referred to a private clinic located in Bandar Abbas city in 1401 with moderate severity of lower wisdom tooth surgery were divided into two groups of 29 patients, one group receiving dexamethasone and the other tranexamic acid. All surgeries will be performed by one surgeon using a single protocol. Then, on the first, third, and sixth days after surgery, the amount of pain, swelling, and bleeding is measured.
Participants/Inclusion and exclusion criteria
All patients aged 18-60 years of both sexes and without systemic problems
Patients with mandibular third molar without pericoronitis and infection
People in whom it is possible to measure and track pain, swelling and bleeding
Intervention groups
Patients in two groups of 29.
The first group: using gelfoam impregnated with dexamethasone
The second group: using gelfoam impregnated with tranexamic acid
Main outcome variables
Pain, swelling, and bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221226056929N1
Registration date:2022-12-29, 1401/10/08
Registration timing:prospective
Last update:2022-12-29, 1401/10/08
Update count:0
Registration date
2022-12-29, 1401/10/08
Registrant information
Name
Fateme Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5364 5945
Email address
neda1223roz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of foam gel impregnated with dexamethasone and tranexamic acid on swelling, bleeding and pain after mandibular wisdom teeth surgery
Public title
Investigating the effect of Gelfoam on reducing swelling, bleeding and pain after mandibular wisdom tooth surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 18-60 years of both sexes and without systemic problems
Patients with mandibular third molar without pericoronitis and infection
People in whom it is possible to measure and track pain, swelling and bleeding.
Exclusion criteria:
Patient's unwillingness to cooperate
Failure to strictly follow postoperative instructions
Existence of systemic diseases and pregnant women
The presence of infection in the patient
Patients who have unusual problems during tooth extraction
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
58
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
It is explained to the patients that they will participate in a clinical trial study and gelfoam administration is not necessary after wisdom tooth surgery according to dental reference books. All surgeries will be performed by the same surgeon using a single protocol and the same type of flap and surgical technique as well as the amount of bone removal. Then, for a series of patients, dexamethasone is used, and for the rest, tranexamic acid with Gelfoam is used, while the patient does not know its type. Then the amount of pain, swelling and bleeding is measured on the first, third and sixth days after surgery.
Placebo
Not used
Assignment
Parallel
Other design features
The number of 58 patients without systemic disease, not taking drugs that interfere with the tested drugs, and also the presence of mandibular wisdom teeth with a moderate degree of severity will be included in the study. Patients were divided into two groups of 29, the first group was administered dexamethasone with Gelfoam and the second group was administered tranexamic acid with Gelfoam. It is explained to the patients that they should call or refer if there is a specific problem or evidence of infection. Otherwise, the amount of pain, swelling and bleeding is measured on the first, third and sixth days.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
University of Medical Sciences campus, Shahrak Nabuvat, The beginning of Imam Hossein Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.HUMS.REC.1401.321
Health conditions studied
1
Description of health condition studied
Pain, swelling and bleeding after surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain, swelling and bleeding
Timepoint
The first, third and sixth day after surgery
Method of measurement
Clinical examination and using a visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The use of dexamethasone-impregnated gelfoam in the socket of the mandibular wisdom tooth
Category
Prevention
2
Description
Intervention group: The use of Tranxamic acid-impregnated gelfoam in the socket of the mandibular wisdom tooth
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Hossamuddin Etemadi's office
Full name of responsible person
Dr. Hossamuddin Etemadi
Street address
8th floor, Kimia Building, Binesh Alley, 7, Fatemieh Crossroads, in front of Shirinkadeh
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964153
Phone
+98 76 3225 4281
Email
hessam12002@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Hossamuddin Etemadi
Street address
Bandar Abbas Faculty of Dentistry ,Nasser Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964153
Phone
+98 76 3335 0458
Email
neda1223roz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
50
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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Hossamuddin Etemadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bandar Abbas Faculty of Dentistry ,Nasser Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964153
Phone
+98 76 3335 0458
Email
hessam12002@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Hossamuddin Etemadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bandar Abbas Faculty of Dentistry, Nasser Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964153
Phone
+98 76 3335 0458
Email
hessam12002@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Hossamuddin Etemadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Nasser Blvd. Bandar Abbas Faculty of Dentistry
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964153
Phone
076333350458
Email
neda1223roz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be played after de-identifying the participants
When the data will become available and for how long
6 months after recording the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Systematic review articles
From where data/document is obtainable
Email: neda1223roz@gmail.com
Its owner: Fatme Zahmtakash
What processes are involved for a request to access data/document