Protocol summary

Study aim
Evaluating the effect of injection of ketorolac or dexamethasone intothe ptrygomandibular space on pain and swelling following removal of lower third mandibular molar
Design
Randomized clinical trial using randomization method with sample size of 60, blind, phase 2
Settings and conduct
The population of patients referring to Kerman University of Medical Science, Dentistry Faculty in order to have a surgery to remove their impacted wisdom tooth or third molar (M3) are randomly divided into two groups. After injecting the anesthetic substance, one of the two materials is injected into petrigom andibuler space. Before commencing on the surgery, a ruler is used to measure the mouth opening right from the tip of incisor teeth. After the surgery, a check list designed based on VAS criteria is used to document the patients’ pain and discomfort right after the surgery, one, three and six hours after the surgery and finally on a daily basis. This process continues for one week. After a week, the mouth opening measurement is done once again for every patient. The number of times and the time each patient has used the painkiller is also recorded.
Participants/Inclusion and exclusion criteria
The subjects entering this study include all those patients in need of one-sided Third Molar (M3) surgery, with the age of more than 18 years, and a weight lower than 100 kg and be in the category of ASA 1, 2. the patients who have used painkiller 24 hours before treatment and who have shown sensitivity toward the injected medicines or have received more than three anesthetic injection.
Intervention groups
A group that receives dexamethasone. A group that receives ketorolac
Main outcome variables
Severity of pain, severity of discomfort, oral opening, side effects, pain reliefs,Intervals between pain relief

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180910040981N1
Registration date: 2019-04-09, 1398/01/20
Registration timing: retrospective

Last update: 2019-04-09, 1398/01/20
Update count: 0
Registration date
2019-04-09, 1398/01/20
Registrant information
Name
Saeed Hajmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 8071
Email address
hajmohammadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of injection of ketorolac or dexamethasone into the ptrygomandibular space on pain and swelling following removal of third mandibular molar
Public title
Evaluating the effect of injection of ketorolac or dexamethasone on pain and swelling following removal of third molar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients enter the study after obtaining written consent. All patients are over 18 years of age The weight of all patients is below 100kg, Depending on the category of American Anesthesia Association in the ASA group one and two. Both groups require the treatment of one-sided low-grade third molars
Exclusion criteria:
Patients who have taken medication or sedation 24 hours before treatment Patients who have a history of allergy to dexamethasone or ketorolac Patients who receive more than 3 local anesthetic injections during the surgical procedure
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 60 identical sheets (30 sheets for Dexamethasone and 30 sheets for Ketorolac) are deposited in a container and the sheets are randomly removed without replacement from the container. And it continues until all the papers are taken.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only a nurse is aware of the type of injectable drug. The surgeon and the patient are unaware of the injected medication and the nurse gives the medication to surgeon.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of kerman University of Medical Sciences
Street address
Haft Bagh Alavi Blv
City
Kerman
Province
Kerman
Postal code
7618759689
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.KMU.REC.1397.248

Health conditions studied

1

Description of health condition studied
impacted teeth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth

Primary outcomes

1

Description
Pain and discomfort severity
Timepoint
Immediately after surgery, 1, 3 and 6 hours later, and eventually on a daily basis for one week.
Method of measurement
Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group:After anesthetic injection, 30 ml of Ketorolac is injected once before surgery
Category
Treatment - Drugs

2

Description
Intervention group: After anesthetic injection, 8 ml of Dexamethasone is injected once before surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental School of Kerman
Full name of responsible person
Saied Hajmohammadi
Street address
ShafaBlv
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8071
Email
dentistryschool@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas Pardakhti
Street address
Shafa Blvd
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8071
Email
hajmohamadisaeed@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Saeed Hajmohamadi
Position
Associate
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial Surgery
Street address
Shafa Blv
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8071
Email
Hajmohamadisaeed@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeed Hajmohammadi
Position
Associate
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial Surgery
Street address
Shafa Blv
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8071
Email
Hajmohamadisaeed@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeed Hajmohamadi
Position
Associate
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial Surgery
Street address
Shafa Blv
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8071
Email
Hajmohamadisaeed@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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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