Effect of local tranexamic acid versus placebo on the incidence of dry socket after mandibular impacted wisdom teeth surgery: a double-blind randomized clinical trial
To assess the effect of local tranexamic acid versus placebo on the incidence of dry socket after mandibular impacted wisdom teeth surgery
Design
This is a double-blind randomized clinical trial, phase II, in which 25 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with bilateral Mandibular impacted wisdom teeth who will refer to the School of Dentistry in Hamadan city during the study period will be enrolled in the trial and the left and right sides of the patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that neither patients nor the physician will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 30 years,
Bilateral Mandibular impacted wisdom teeth,
Exclusion criteria:
Presence of infection or inflammation around the hidden teeth,
Poor oral hygiene,
Allergy to topical anesthesia,
Analgesic and antibiotic use,
Taking oral contraceptive pills,
Smoking and drug use,
Using antidepressants medications
Intervention groups
Intervention group:
Surgery of mandibular impacted wisdom teeth on one side plus placement of gel foam including tranexamic acid
Control group:
Surgery of mandibular impacted wisdom teeth on one side plus placement of gel foam including normal saline
Main outcome variables
The severity of pain, elimination of blood clots, mouth odor, the severity of swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N313
Registration date:2019-10-22, 1398/07/30
Registration timing:retrospective
Last update:2019-10-22, 1398/07/30
Update count:0
Registration date
2019-10-22, 1398/07/30
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local tranexamic acid versus placebo on the incidence of dry socket after mandibular impacted wisdom teeth surgery: a double-blind randomized clinical trial
Public title
Effect of local tranexamic acid versus placebo on the incidence of dry socket after mandibular impacted wisdom teeth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 30 years,
Bilateral Mandibular impacted wisdom teeth,
Exclusion criteria:
Presence of infection or inflammation around the hidden teeth,
Poor oral hygiene,
Allergy to topical anesthesia,
Analgesic and antibiotic use,
Taking oral contraceptive pills,
Smoking and drug use,
Using antidepressants medications
Age
From 18 years old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "right" on one sheet and "left" on another. Then, by referring to every patient, one of the sheets will be randomly taken. According to whether the sheet is taken right or left is assigned to the intervention group and the other side to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as triple-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
IR.UMSHA.REC.1397.634
Health conditions studied
1
Description of health condition studied
Impacted wisdom teeth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
The severity of pain
Timepoint
On the third, seventh and fourteenth days after surgery
Method of measurement
Using Visual Analogue Scale (VAS)
2
Description
Elimination of blood clots
Timepoint
On the third, seventh and fourteenth days after surgery
Method of measurement
By clinical examination
3
Description
Mouth odor
Timepoint
On the third, seventh and fourteenth days after surgery
Method of measurement
By clinical examination
4
Description
The severity of swelling
Timepoint
On the third, seventh and fourteenth days after surgery
Method of measurement
By clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Surgery of mandibular impacted wisdom teeth on one side plus placement of gel foam including tranexamic acid
Category
Treatment - Drugs
2
Description
Control group: Surgery of mandibular impacted wisdom teeth on one side plus placement of gel foam including normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Dr. Tanaz Raeipoor
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
t_ra30pour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Tanaz Raeipoor
Position
Dentistry Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
t_ra30pour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Amir Hussein Babaeisoroor
Position
Oral and maxillofacial surgeon
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr.amirsoroor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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