Protocol summary

Study aim
Comparison of the effect of preoperative betamethasone and ketorolac injection on postoperative pain, swelling and trismus
Design
Patients requiring mandibular third molar surgery are randomly divided into 2 intervention groups with equal number, gender, and similar severity. In each group, the anesthesia process will be performed with the same protocol and using perzocaine-E. Then 1mL of betamethasone LA or 30 mg of ketorolac is injected into the master muscle. Surgery is performed by the same surgeon in a dental office using a standard procedure appropriate to the type of incision. After work, patients are given the same painkillers (acetaminophen 325mg) and antibiotics (amoxicillin 500mg and metronidazole 250mg, one every 8 hours). Outcome assessment is performed before surgery, two days and 7 days after surgery. Patients in this study are blind.
Settings and conduct
Dr nazari dental clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: ages of 18 and 40, physical health (ASA I or II), the presence of a third mandibular molars whose occlusion is confirmed by panoramic radiography and free of infection and pericoronitis. Exclusion criteria: Concomitant use of antibiotics and nsaid drugs, salicylates, anticoagulants, anticonvulsants, and valproate . Consumption of fines for each of these substances in the past month (drugs, alcohol, opium, smoking) A person who has smoked at least two cigarettes a day in the past month, underlying diseases that interfere with wound healing such as systemic diseases such as diabetes, hypertension, Gastrointestinal diseases, kidney and lung disease, pregnancy, and any allergies to the drugs used in this study are surgical complications that are difficult to classify according to (Pell and Gregory classification Winter classification).
Intervention groups
1.KETOROLAC 2.BETAMETHASONE LA
Main outcome variables
PAIN ,SWELLING , TRISMUS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191127045516N6
Registration date: 2022-02-26, 1400/12/07
Registration timing: registered_while_recruiting

Last update: 2022-02-26, 1400/12/07
Update count: 0
Registration date
2022-02-26, 1400/12/07
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
2022-02-24, 1400/12/05
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of Ketorolac and Betamethasone injection on post complications of third molar surgery (A clinical trial)
Public title
comparison of the effect of Ketorolac and Betamethasone injection on post complications of third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Physical health (ASA I or II) free of infection and pericoronitis. the presence of a third mandibular molars whose occlusion is confirmed by panoramic radiography age18 to 40 years old
Exclusion criteria:
Concomitant use of antibiotics and nonsteroidal anti-inflammatory drugs, salicylates, anticoagulants, anticonvulsants, and valprates is due to interaction with the injectable substance (ketorolac). Current use of any of these substances in the past month (drugs, alcohol, opium, smoking) Someone who has smoked at least two cigarettes a day in the past month Difficulty of surgery based on Pell and Gregory classification (Winter classification). allergies to the drugs used in this study Diseases that interfere with wound healing such as systemic diseases such as diabetes, hypertension, gastrointestinal diseases, kidney and lung and heart diseases, pregnancy.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the randomization block method with classification will be used. The classification will be based on gender and difficulty of surgery. Random sequencing will be performed by a statistical expert using Excel software with RANDOM function and Sort command in each class separately and codes A and B. To prevent the prediction of the last patient group in each block, blocks with different sizes of two, four and six in all classes will be used. Randomization will be considered for 40 patients in each class.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done on one level, only the participant. Participants will not be able to identify the type of injectable drug because they will not be informed of the drug group to which they will belong. Patients are grouped through exactly the same envelopes containing the letters A or B. The physician is aware of the relationship between the letters and the drug, but patients are unaware. Patients will be informed about the drugs used in the trial before participating in the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Kermanshah University of Medical Sciences
Street address
SHAHID BEHESHTI Blvd
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.KUMS.REC.1400.801

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 severity
Timepoint
second and seventh day after surgery
Method of measurement
visual analogue scale

2

Description
swelling
Timepoint
second and seventh day after surgery
Method of measurement
visual analogue scale

3

Description
trismus
Timepoint
the second and seventh day after surgery
Method of measurement
Maximum mouth opening limitation less than 35 mm

4

Description
surgery difficulty
Timepoint
before the surgery
Method of measurement
Using panoramic radiography based on tooth position angle, depth and position relative to Ramos mandible - Based on panoramic radiographic classification (Pell and Gregory classification, Winter classifocation) -

5

Description
patient general satisfaction
Timepoint
the second and seventh day after surgery
Method of measurement
visual analogue scale

6

Description
maximum mouth opening
Timepoint
beofre the surgery and second and seventh day after surgery
Method of measurement
interincisal distance between mandibular and maxillary central teeth

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: A single intramuscular injection of 3mg betamethasone LA in 1mL (manufactured by Exir Pharmaceutical Company) in the master muscle immediately after injection of 2% lidocaine anesthesia.
Category
Prevention

2

Description
Intervention group 2: A single intramuscular injection of 30 mg in 1 mL of ketorolac (manufactured by Exir Pharmaceutical Company) in the master muscle immediately after injection of 2% lidocaine anesthesia.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Nazari Dental Clinic
Full name of responsible person
Dr Hamed Nazari
Street address
Dabirazam 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
Reza Khodarahmi
Street address
Shahid beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3729 6591
Email
research_it@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
Hamed Nazari
Position
Assistant proffesor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shariati St.Dentistry School.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
Nazari.hamed67@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
Shariati St.Dentistry school
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
Parnian Tarabosi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shariati St.Dentistry School
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
pn.tarbosi@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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