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Comparison of the effectiveness of ketorolac injection into the masseter and medial pterygoid muscles in preventing the post-operative complications after mandibular third molar sugrery

Protocol summary

Study aim
Comparison of the effectiveness of ketorolac injection into the masseter and medial pterygoid muscles in preventing the post-operative complications after mandibular third molar surgery
Design
randomized double blinded Clinical trial,parallel groups,phase 2 on 84 patients.Randomisation was done by generating random numbers using Excel software.
Settings and conduct
Patients in need of mandibular third molar surgery are randomly divided into 2 groups with equal numbers.in each group,the anesthesia process will be done with the same protocol using Persocaine-E.Then 30 mg ampoule of Ketorolac Thrometamine is injected in to the masseter or internal pterygoid muscle.the Surgery is done by the same surgeon using the standard method according to the type of impaction in the dental clinic.after that,patients are given analgesics(acetaminophen325mg)and antibiotics(amoxicillin500mg and metronidazole250mg,number:20, one every 8 hours)in the same way.outcome assessment is done before surgery,2 and 7 days after surgery.patients and outcome assessors are blind in this study.
Participants/Inclusion and exclusion criteria
Inclusion:1-ASA I or II 2-presence of a confirmed impacted mandibular third molar with no infection and pericoronitis3- patient is ready to sign the testimonial.Exclusion:1-History of underlying diseases 2-current consumption of drugs,alcohol,opiums3-smoking 4-recent consumption of anti-inflammatory drugs and antibiotics5-pregnant women 6- any allergies
Intervention groups
group 1: injection of 30 mg ampoule of Ketorolac Tromethamine in to the masseter muscle immediately after anesthesia . group 2: injection of 30 mg ampoule of Ketorolac Tromethamine in to the internal pterygoid muscle immediately after anesthesia.
Main outcome variables
severity of pain,swelling,Paresthesia,General satisfaction,Trismus,Maximum opening of mouth, surgery difficulty level,number of analgesics taken

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191127045516N2
Registration date: 2020-12-15, 1399/09/25
Registration timing: registered_while_recruiting

Last update: 2020-12-15, 1399/09/25
Update count: 0
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
hamed Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 2842
Email address
hamed.nazari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of ketorolac injection into the masseter and medial pterygoid muscles in preventing the post-operative complications after mandibular third molar sugrery
Public title
Comparison of the effectiveness of ketorolac injection into the masseter and medial pterygoid muscles in preventing the post-operative complications after mandibular third molar sugrery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I or II health status. presence of a impacted mandibular third molar confirmed by a panoramic image absence of the mandibular third molar infection and pericoronitis The patient is ready to take part in the study and sign the testimonial
Exclusion criteria:
History of underlying diseases affecting the wound healing process like systemic diseases(diabetes,high blood pressure,gastrointestinal system diseases,kidney disorders,heart and lung diseases) current consumption of drugs,alcohol,opiums(consumption of any of these substances during the last month) smoking(someone who has smoked at least two cigarettes a day during the last month) recent consumption of anti- inflammatory drugs and antibiotics pregnant women any allergies or Hypersensitivities to the drugs used in this study
Age
From 18 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the random allocation law,Random numbers are generated using Excel software by a statistician.to do this,three-digit codes are generated and the last digit on the right indicates the patient group.if the number obtained is odd(1,3,5,7,9),the patient is in the internal pterygoid muscle injection group and if the number is even(0,2,4,6,8),the patient is in the masseter muscle injection group.
Blinding (investigator's opinion)
Double blinded
Blinding description
participants and outcome assessor are blinded in this study.as the ketorolac injection is done after the anesthesia,patient will not know the exact location of the injection(masseter or internal pterygoid muscle)and will not be informed.also the outcome assessor will not be informed which muscle was injected.
Placebo
Not used
Assignment
Parallel
Other design features
patients who have bilateral surgery have at least 15-days interval between each surgery and are admitted to study for only one surgery.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Boulevard, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-09-12, 1399/06/22
Ethics committee reference number
IR.KUMS.REC.1399.607

Health conditions studied

1

Description of health condition studied
severity of pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

2

Description of health condition studied
Trismus
ICD-10 code
G71.8
ICD-10 code description
Other primary disorders of muscles

3

Description of health condition studied
swelling
ICD-10 code
R22.9
ICD-10 code description
Localized swelling, mass and lump, unspecified

4

Description of health condition studied
paresthesia
ICD-10 code
R20
ICD-10 code description
Disturbances of skin sensation

Primary outcomes

1

Description
severity of pain
Timepoint
before surgery,2 and 7 days later
Method of measurement
Visual Analogue Scale(VAS)

2

Description
swelling
Timepoint
2 and 7 days after surgery
Method of measurement
Visual Analogue Scale(VAS)

3

Description
General satisfaction
Timepoint
2 and 7 days after surgery
Method of measurement
Visual Analogue Scale(VAS)

4

Description
Trismus
Timepoint
2 and 7 days after surgery
Method of measurement
Restrictions on opening the mouth(mild,moderate,severe)

5

Description
paresthesia
Timepoint
2 and 7 days after surgery
Method of measurement
yes/no

6

Description
Maximum opening of the mouth
Timepoint
before surgery,2 and 7 days later
Method of measurement
by a ruler(0-50 millimetre)

7

Description
Number of analgesics taken
Timepoint
2 and 7 days after surgery
Method of measurement
number(0-100)

8

Description
difficulty of the surgery
Timepoint
Before surgery
Method of measurement
according to panoramic radiograph based on spatial direction,depth and ramus relationship(easy,moderate,difficult)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: injection of 30 mg ampoule of Ketorolac Tromethamine in to the masseter muscle immediately after anesthesia injection.
Category
Prevention

2

Description
Intervention group 2: injection of 30 mg ampoule of Ketorolac Tromethamine in to the internal pterygoid muscle immediately after anesthesia injection.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Nazari Dental clinic
Full name of responsible person
Hamed Nazari
Street address
Dabiraezam st.
City
Kermanshah
Province
Kermanshah
Postal code
6713737364
Phone
+98 83 3729 3520
Email
Nazari.hamed67@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3729 6591
Fax
Email
faridnajafi@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
Hadis Yari
Position
Under graduated student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The school of Dentistry, shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
h.yari7493@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hamed Nazari
Position
Assistant professor
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
Hadis Yari
Position
Under graduated student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The school of Dentistry, shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
h.yari7493@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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