Comparison of Articaine 4% and Lidocaine 2% for Buccal Infiltration After Inferior Alveolar Nerve Block For Intraoperative Pain Control During Impacted Mandibular Third Molar Surgery
Comparison of buccal artichoke infiltration of 4% and lidocaine 2% after anesthesia of lower alveolar nerve block in pain control during mandibular occlusal surgery
Design
Parallel double-blind randomized clinical trial
Settings and conduct
4% articaine and 2% Lidocaine with 1: 200,000 epinephrine are both made by Elixir Factory. After the anesthetic was injected, the time of onset of anesthesia was recorded with a chronometer. The use of chi-square test was evaluated. A ten-digit VAS system was used to evaluate the pain during removal of the third molar of the mandible using an elevator or milling machine and pain after surgery up to 15 hours after surgery.
Participants/Inclusion and exclusion criteria
Third Molar Surgery Indication
Intervention groups
Articaine and Lidocaine Group
Main outcome variables
Pain - adverse effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220524054979N1
Registration date:2022-07-16, 1401/04/25
Registration timing:registered_while_recruiting
Last update:2022-07-16, 1401/04/25
Update count:0
Registration date
2022-07-16, 1401/04/25
Registrant information
Name
Samaneh Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4433 3600
Email address
mmd.samaneh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Articaine 4% and Lidocaine 2% for Buccal Infiltration After Inferior Alveolar Nerve Block For Intraoperative Pain Control During Impacted Mandibular Third Molar Surgery
Public title
Painkiller effect of 4% Lidocaine versus 4% Articaine after wisdom teeth extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mandibular Third Molar Surgery Indication
Exclusion criteria:
Systemic Disease
Analgesics Consumption during last 24 hours
Allergic Reaction to Local Anesthesia Agents
Hyperalgesic Syndrome
Pregnancy and Lactating
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize, patients are divided into two groups using the blocks made by statistical software: In the first group, the surgery is conducted using Lidocaine 2%, and in the second group, the surgery is performed using Articaine 4%. All surgeries will be performed by an oral and maxillofacial surgeon and in one room with an assistant. The type of anesthesia will be selected randomly in the first surgery and will not be told to the surgeon prior to the start of injection and finishing the surgical procedure.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researchers examining the parameters of anesthesia success will not be aware of the type of intervention performed on the patient. Also, patients themselves will not be aware of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical science ethics in Biomedicine researches committee
Street address
Alborz
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-11-16, 1400/08/25
Ethics committee reference number
IR.UMSU.REC.1400.309
Health conditions studied
1
Description of health condition studied
Oral Surgery
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Postoperative Pain
Timepoint
7, 4 and 21 days
Method of measurement
Visual Analog Scale
2
Description
Anesthesia Duration
Timepoint
0-12
Method of measurement
Cronometer
3
Description
Anesthesia Start
Timepoint
0-12
Method of measurement
Watch
4
Description
Surgery Duration
Timepoint
0-10
Method of measurement
Cronometer
Secondary outcomes
empty
Intervention groups
1
Description
Local Anesthesia administration in the mandible with Articaine 4% (SeptocaineFrance, Septodont) (with 1:100000 Epinephrine,3.6 ml, using 27 gauge needle with the speed of 1 mL/min. The needle bevel was at the bone side. Group 1 : Inferior Alveolar nerve Block Anesthesia For Third Molar
Category
Treatment - Drugs
2
Description
Local Anesthesia administration in the mandible with Lidocaine 2% (xylopen; Exir pharmaceutical Co, Iran) (with 1:100000 Epinephrine,3.6 ml, using 27 gauge needle with the speed of 1 mL/min. The needle bevel was at the bone side. Group 1 : Inferior Alveolar nerve Block Anesthesia For Third Molar
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Alborz Clinic
Full name of responsible person
Farhad Nojan
Street address
Alborz
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3336 3600
Email
farhad_nojan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia Dental Clinic
Full name of responsible person
Dr. Samaneh Mohammadi
Street address
Alborz
City
Urmia
Province
West Azarbaijan
Postal code
:5714783734
Phone
+98 44 3336 3600
Email
mmd.samaneh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia Dental Clinic
Proportion provided by this source
80
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
Urmia University of Medical science
Full name of responsible person
Ehsan Hooshyar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Alborz
City
Urmia
Province
West Azarbaijan
Postal code
:5714783734
Phone
+98 44 3336 3600
Email
Hooshyar.e@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Science
Full name of responsible person
Farhad Nojan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Alborz
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3336 3600
Email
farhad_nojan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Samaneh Mohammadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Alborz
City
Urmia
Province
West Azarbaijan
Postal code
:5714783734
Phone
+98 44 4433 3600
Fax
Email
mmd_samaneh@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
No
When the data will become available and for how long
After Publication
To whom data/document is available
Patients
Under which criteria data/document could be used
Informed Consent
From where data/document is obtainable
Clinicians
What processes are involved for a request to access data/document