Comparison of the Effect of Topical Dexamethasone Injection with Rinsing of Extraction Sockets with Dexamethasone in Reducing Pain after Impacted Mandibular Third Molars
Comparison of the effect of topical injection of dexamethasone and rinsing of extracted teeth with dexamethasone and non-use of dexamethasone in Reduction of pain after impacted third molar of lower jaw
Design
A control trial with a control group, with parallel groups, blinded postoperative care and outcome assessment, randomized, phase 4 on 114 patients was used for randomization from www.randomizer.org
Settings and conduct
A clinical trial consisted of 114 patients referred to Bushehr Dental Clinic with impacted third molars in the mandible on each side (right or left).
Patients are divided into 3 groups. Each group includes 38 patients.
Before starting work, patients take a panoramic radiograph to examine the location of the tooth, their angle and mandibular nerve involvement, andThe criteria for entry and exit criteria are approved.
After surgery, the tissues of the dental follicle are removed. In one group of patients, after surgery, rinsing is performed with 50 cc of normal saline and finally the socket of extracted tooth is rinsed with dexamethasone. In the second group, after surgery and removal of follicular tissues, the socket is rinsing with 50cc of normal saline. After that, it is sutured and finally injected in the trygomandibular space. In the third group (control) after surgery and removal of follicular tissues, the socket is rinsing with 50cc of normal saline.
Participants/Inclusion and exclusion criteria
Age over 18 years and absence of uncontrolled systemic disease and low impacted wisdom teeth with mesiovangular angle
Intervention groups
1. Intramuscular injection of dexamethasone
2. rinsing with dexamethasone
3. Do not inject dexamethasone
Main outcome variables
pain
Trismus
Inflammation
swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201101049209N2
Registration date:2020-11-18, 1399/08/28
Registration timing:registered_while_recruiting
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Milad Parvin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3542 8269
Email address
m.parvin@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-29, 1399/08/08
Expected recruitment end date
2020-11-28, 1399/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Topical Dexamethasone Injection with Rinsing of Extraction Sockets with Dexamethasone in Reducing Pain after Impacted Mandibular Third Molars
Public title
Dexamethasone Effect on Pain Reduction and Swelling after Surgery in the Lower Jaw
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old
No pericoronitis
Absence of uncontrolled systemic disease
Impacted Third molar of mandible with mesioangular angle
Exclusion criteria:
Age
From 18 years old to 25 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
.For segmentation of patients into three groups of 38 (group A)and the silent rinsing of extracted teeth with dexamethasone (Group B)and Do not prescribe dexamethasone (group C), the Permuted Block randomization method has been used as block size of 6 blockate was used to create a balance in the number of samples allocated to each of the studied groups. the size of each block size method is used. The random layout was created using the free website Randomization.com (http://randomization.com). From the order of the Permuted Table Randomizotion and the arrival of the participants to study the only surgeon, the assessor should not be aware of any intervention that takes place for the individual and the block size. Thus, the allocation of data will remain hidden by the end of the study. That way, each participant will be assigned to the intervention or control groups and peform the expected process by the surgeon.
Blinding (investigator's opinion)
Single blinded
Blinding description
the impact assessor is not aware of the intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Uiversity of Medical Science Bushehr University of Medical Sciences
Street address
Salman Farsi
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.BPUMS.REC.1399.117
Health conditions studied
1
Description of health condition studied
pain and sweliing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patients' pain
Timepoint
at times, 2 hours after surgery, 6 hours after surgery, 24 hours after surgery, 72 hours after surgery, and finally 7 days after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Trismus
Timepoint
at times, before surgery, after surgery and on the first, third and seventh days.
Method of measurement
measuring the distance between the incisal edge at the opening of the mouth and with a caliper device in millimeters
Intervention groups
1
Description
Intervention group: Receive dexamethasone by injection into the trygmandibular space
Category
Treatment - Drugs
2
Description
Intervention group: rinsing the socket of extracted teeth with dexamethasone
Category
Treatment - Drugs
3
Description
Control group: Do not take dexamethasone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
dental clinic of Bushehr University of Medical Sciences
Full name of responsible person
Amir Gorre
Street address
Emam Khomeini
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
ّFatemeh Dehghanazad
Street address
Emam Khomeini
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
10
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
Boushehr University of Medical Sciences
Full name of responsible person
Hassan Barbarz
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Emam Khomeini
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Milad Parvin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Emam Khomeini
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Hassan Barbarz
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Emam Khomeini
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.ac.ir
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
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
The data is numbered from one to ten and can be shared
When the data will become available and for how long
two months after the publication of the dissertation text
To whom data/document is available
every one
Under which criteria data/document could be used
Unconditional
From where data/document is obtainable
college
What processes are involved for a request to access data/document