The effect of Intra Masseter Dexamethasone Injection on Postoperative Complications (pain, oedema and trismus) after Impacted and Semi Impacted Third Molar Surgery: A split-mouth randomized trial
The effect of Intra Masseter Dexamethasone Injection on Postoperative Complications (pain, oedema and trismus) after Impacted and Semi Impacted Third Molar Surgery
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Patients who refer to dental clinic of Medical University of Gorgan go under double side surgery with two impacted or semi-impacted wisdome teeth with same condition.
Half our before surgery the one side get injected by 8 mg of dexamethasone intramasseter.
For the other side nothing get injected.
Time between two surgeries will be 2 week and there are two follow up in second and seventh day for each surgery due to evaluating the amount of pain, swelling and trismus.
Participants/Inclusion and exclusion criteria
1.20 to 45 years of age
2.Third mandibular molar impaction in both side
3.Kind of impaction and difficulty in both impacted tooth be even ( both semi-impacted or both impacted and situation of impaction be even)\
1.Using of interventionist medications with healing process
2.Having systemic disorders
3.Having oral and maxillofacial disease or trauma to the region
4.Having infection of pericoronitis in field of surgery
5.Manifestation of any allergic reaction, sensibility increase or immunosyncratic to the drugs
Intervention groups
Side of the mouth that surgery is performing half our before surgery is injected by intramasseter dexamethasone
Main outcome variables
Amount of Pain Swelling Trismus
General information
Reason for update
Acronym
TMDC
IRCT registration information
IRCT registration number:IRCT20171229038128N1
Registration date:2018-03-10, 1396/12/19
Registration timing:registered_while_recruiting
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Mohamad ali Rahnama
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3255 0565
Email address
m.rahnama@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Intra Masseter Dexamethasone Injection on Postoperative Complications (pain, oedema and trismus) after Impacted and Semi Impacted Third Molar Surgery: A split-mouth randomized trial
Public title
The effect of Intra Masseter Dexamethasone Injection on Postoperative Complications after Impacted and Semi Impacted Third Molar Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 45 years of age
Third mandibular molar impaction in both side
Kind of impaction and difficulty in both impacted tooth be even ( both semi-impacted or both impacted and situation of impaction be even)
Exclusion criteria:
Using of interventionist medications with healing process
Having systemic disorders
Having oral and maxillofacial disease or trauma to the region
Having infection of pericoronitis in field of surgery
History of allergy to lidocaine or other drugs
Manifestation of any allergic reaction, sensibility increase or immunosyncratic to the drugs Definition of intervention group: Another side of the mouth that surgery is performing half our before surgery is injected by intramasseter dexamethasone. Definition of control group: Another side of the moth that surgery is performing half our before surgery is not injected by dexamethasone (all situation is the same except injection of dexamethasone)
Age
From 20 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
19
More than 1 sample in each individual
Number of samples in each individual:
2
Third lower left and right mandibaular tooth
Randomization (investigator's opinion)
Randomized
Randomization description
In this type of study, randomization occurs rather than on patients, oral surgery occurs or oral areas occur. Random allocation method will be performed on a simple random type (random number list). A randomized list will be prepared by an epidemiologist who is not involved in the implementation of the interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and assessing the outcomes of the study (pain, swelling and trismus) do not know the random allocation of oral areas.
Placebo
Not used
Assignment
Parallel
Other design features
This study is based on split-mouth randomized clinical trial and will be performed to evaluate the effect of intra -Masseter dexamethasone injection on the outcomes of post-operative bilateral third molars. The most important goal of this commonly used method in interventional studies Split-Mouth Design is the elimination of inter-subject variability, because each person is self-controlled. Therefore, in this type of study, randomization occurs on teeth or oral areas rather than on patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Dental clinic of Golestan University of Medical Science, Obverse Edalat 97 alley, Naharkhoran Blv, Gorgan,Iran
City
Gorgan
Province
Golestan
Postal code
4916953358
Approval date
2017-12-17, 1396/09/26
Ethics committee reference number
IR.GOUMS.REC.1396.231
Health conditions studied
1
Description of health condition studied
Postoperative Complications after Impacted and Semi Impacted Third Molar Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
2 and 7 days after intervention
Method of measurement
VAS(Visual Analogue Scale )
2
Description
Swelling
Timepoint
2 and 7 days after intervention
Method of measurement
Swelling is measured using the reference points (lower abdomen of the lobe of the ear to the corner of the mouth and the lateral edges of the eye to the mandible corner), through a flexible ruler (a dial pad for a more accurate measurement of the curved areas) and the vignette. The caliber is made up of a combination of a dial pad and a movable veneer. The vernier ruler has two antennas, small tentacles for measuring the inside diameter and large tentacles for measuring the external diameter of the objects). Will be evaluated.
3
Description
(Trismus)
Timepoint
2 and 7 days after intervention
Method of measurement
The Trismus value will be measured by measuring the maximum distance between the two maxillary and maxillary maxillary incisors by the ventricular calcium
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:On one side of the oral surgery, dexamethasone injection of 8 mg, half an hour before surgery, and IM into the muscle of the master and will be performed by the surgeon
Category
Treatment - Surgery
2
Description
Control group:The other side of the mouth is not injected dexamethasone prior to the third molar surgery (all surgical conditions such as the oral side of the intervention except dexamethasone injection).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school of Golestan University of Medical Sciences
Full name of responsible person
Mohamadali Rahnama
Street address
Dental clinic of Golestan University of Medical Science, Obverse Edalat 97 alley, Naharkhoran Blv, Gorgan,Iran
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 0565
Email
m.rahnama@goums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Mohamadreza Honaravar
Street address
Dental clinic of Golestan University of Medical Science, Obverse Edalat 97 alley, Naharkhoran Blv, Gorgan,Iran
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3245 1660
Email
m.rahnama@goums.ac.ir
Web page address
http://goums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Science
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
Golestan Universities of Medical Science
Full name of responsible person
Mohamadali Rahnama
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental clinic of Golestan University of Medical Science, Obverse Edalat 97 alley, Naharkhoran Blv, Gorgan,Iran
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 0565
Email
m.rahnama@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan Universities of Medical Science
Full name of responsible person
Mohamadali Rahnama
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental clinic of Golestan University of Medical Science, Obverse Edalat 97 alley, Naharkhoran Blv, Gorgan,Iran
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 0565
Email
m.rahnama@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Golestan Universities of Medical Science
Full name of responsible person
Mohamadali Rahanma
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental clinic of Golestan University of Medical Science, Obverse Edalat 97 alley, Naharkhoran Blv, Gorgan,Iran
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 0565
Email
m.rahnama@goums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data are available after Unrecognizable
When the data will become available and for how long
6 month after printing
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Research plan
From where data/document is obtainable
Dental school of Golestan University of Medicine Scinces
What processes are involved for a request to access data/document
Submit an application to research department of dental school