Comparison of the effectiveness of ketorolac subperiosteal and infiltrate injections into the buccal mucosa in preventing postoperative complications after impacted third molar surgery.
Comparison of the effectiveness of ketorolac sub periosteal and infiltrate injections into the buccal mucosa in preventing postoperative complications after impacted third molar surgery..
Design
This study is a double-blind clinical trial. The study population includes all patients who refer to a private dental clinic in Kermanshah for wisdom tooth surgery. 84 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study which will be conducted in private dental clinic of Kermanshah is double blinded one that The patient and physician evaluating the outcome will be kept blind to the exact injection site.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, Physical health, Presence of an impacted molar confirmed by panoramic radiography and is free of infection and pericoronitis; No concomitant use of nonsteroidal anti-inflammatory drugs, salicylates, anticoagulants, anticonvulsants, and valproate due to interference with the injectable substance (ketorolac).
Exclusion criteria: Recent use of anti-inflammatory drugs and antibiotics; Having underlying diseases such as diabetes, gastrointestinal diseases, etc; Current consumption of drugs, alcohol and opium over the past month; pregnant women
Intervention groups
The first intervention group will receive 30 mg of single-dose ketorolac (Alborz Pharmaceutical Company) as a subperiosteal injection immediately after anesthesia injection of the alveolar and lingual nerve blocks.
The second intervention group will receive 30 mg of single-dose ketorolac (Alborz Pharmaceutical Company) as an infusion injection in the buccal mucosa immediately after injection of anesthesia of the alveolar and lingual nerve blocks.
Main outcome variables
Pain intensity; Trismus; paresthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N155
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
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of ketorolac subperiosteal and infiltrate injections into the buccal mucosa in preventing postoperative complications after impacted third molar surgery.
Public title
Comparison of two ketorolac injection methods on complications after third tooth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Physical health
Presence of an impacted third molar is confirmed by panoramic radiography and is free of infection and pericoronitis
No concomitant use of nonsteroidal anti-inflammatory drugs, salicylates, anticoagulants, anticonvulsants, and valprates due to interference with the injectable substance (ketorolac).
Exclusion criteria:
Recent use of anti-inflammatory drugs and antibiotics
Having underlying diseases such as diabetes, gastrointestinal diseases, etc.
Current consumption of drugs, alcohol and opium over the past month
Pregnant women
Age
From 18 years old to 40 months old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The permutation random block is used for randomization. In this way, first, the total sample size and the ratio of sample size in groups are determined. Then, the number of samples will be selected from the table of random numbers of single-digit numbers between 0 and 9. For studies with two groups, the numbers 0-9 are divided into two equal blocks with a probability of assigning an individual to each block is 0.5. Block 4-0 for the first group and block 5-9 for the second treatment can be used. Based on the selected numbers from the table of random numbers and the determination of blocks, it is clear in which group each person who enters the study will be placed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and physician evaluating the outcome will be kept blind to the exact injection site.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-09-12, 1399/06/22
Ethics committee reference number
ir.kums.rec.1399.584
Health conditions studied
1
Description of health condition studied
Impacted teeth
ICD-10 code
K01
ICD-10 code description
Embedded and impacted teeth
Primary outcomes
1
Description
Pain intensity
Timepoint
Two and 7 days after dental surgery
Method of measurement
Based on visual pain scale
2
Description
Trismus
Timepoint
Two and 7 days after dental surgery
Method of measurement
Question from the patient (Low, medium, severe)
3
Description
Paresthesia
Timepoint
Two and 7 days after dental surgery
Method of measurement
Question from the patient (Low, medium, severe)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 30 mg of single-dose ketorolac (Alborz Pharmaceutical Company) as a subperiosteal injection immediately after anesthesia injection of the alveolar and lingual nerve blocks.
Category
Treatment - Other
2
Description
The second intervention group will receive 30 mg of single-dose ketorolac (Alborz Pharmaceutical Company) as an infusion injection in the buccal mucosa immediately after injection of anesthesia of the alveolar and lingual nerve blocks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal clinic of Dr. Hamed Nazari
Full name of responsible person
Dr. Hamed Nazari
Street address
Dabira Azam Street, Arshia Building
City
Kermanshah
Province
Kermanshah
Postal code
6715813149
Phone
+98 83 3838 1541
Email
Nazari.hamed67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mehrnaz Pourahmadi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
140dent95mehr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hamed Nazari
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
Nazari.hamed67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehrnaz Pourahmadi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
140dent95mehr@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe