The effectiveness of intramuscular v/s submucosal injection of dexamethasone on third molar surgery complications.
Design
Forty-four patients with mesioangular mandibular impacted third molar , without any specific systemic conditions, are randomly divided into 2 groups based on four random blocks.
Settings and conduct
This research is conducted in the department of surgery at the College of International Campus. Forty-four patients are randomly divided into two groups, and each patient is not aware of the type of injection.
Then, in the course of surgery, before surgery, dexamethasone injection was performed in 2 groups (submucosal group and another intramuscular group).
Participants/Inclusion and exclusion criteria
The patients with mesioangular mandibular third molar in the age of 20-35 without any history of systemic disease.
Intervention groups
we do the injection of dexamethasone submucosaly in one group and intramusculary in the other one.
Main outcome variables
Decrease the pain after third molar surgery.
Increase the quality of life after surgery.
Decrease the swelling after third molar surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038204N1
Registration date:2018-02-04, 1396/11/15
Registration timing:registered_while_recruiting
Last update:2018-02-04, 1396/11/15
Update count:0
Registration date
2018-02-04, 1396/11/15
Registrant information
Name
mahsa tavahodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4458 2706
Email address
mahsa.tavahodi72@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Post surgical effect of submucosal v/s intramascular dexamethasone on pain and swelling after mandibular third molar surgery
Public title
Dexamethasone effect on pain and swelling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with mesioangular mandibular third molar surgery
The patients of 20-35 years old
Exclusion criteria:
The patients with any systemic disease
Different types of impaction except mesioangular type
The patients that use any kind of medicine
The patients that mention a record of allery to dexamethasone drug
The patients that cant be present at the surgery follow up
Age
From 20 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in groups in based on block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
In this project,after giving the necessary advices to the patient, they wont be aware of being in which group.
The person that do the measurements in follow ups , is not aware too.
َAlso the surgeon doesnt know the type of injection.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Vice-Chancellor for Research, Tehran University of Medical Sciences
Street address
keshavarz BLV.
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-11-15, 1395/08/25
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1033
Health conditions studied
1
Description of health condition studied
Mandibular impacted third molar tooth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reducing of pain.
Timepoint
Measuring the pain before surgery, on the first, third and seventh days after surgery.
Method of measurement
Measuring the pain using visual analogue scaling.
2
Description
Reducing the swelling.
Timepoint
Measuring the swelling before surgery, on the first, third and seventh days after surgery
Method of measurement
Examining the swelling by measuring facial landmarks.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group: 4mg of dexamethasone injected submucosaly at the site of surgery 30 minutes before the start of operation.
Category
Treatment - Drugs
2
Description
Intervention group: The second intervention group injects 4 mg dexamethasone intramuscularly 30 minutes before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran university-International campus of medical science
Full name of responsible person
Mojtaba Salehi Karizmeh
Street address
Khani abad, Mahan Ave., International campus of medical science
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
+98 21 5585 1131
Email
Mahsa.tavahodi72@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Salehi Karizmeh
Street address
Khani abad, Mahan Ave., International campus of medical science
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
+98 21 5585 1131
Email
mojtabasalehi18@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Financing is done by myself.
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Tavahodi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Khani abad, Mahan Ave., International campus of medical science
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
+98 21 5585 1131
Email
mahsa.tavahodi72@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Salehi Karizmeh
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khani abad, Mahan Ave., International campus of medical science
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
+98 21 5585 1149
Email
mojtabasalehi18@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Tavahodi
Position
Tehran
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Khani abad, Mahan Ave., International campus of medical science
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
+98 21 5585 1131
Email
mahsa.tavahodi72@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD