A comparison of two anesthetic methods with 2% lidocaine for the surgical removal of impacted mandibular third molars: IAN block technique vs local infiltration technique
A comparison of two anesthetic methods with 2% lidocaine for the surgical removal of impacted mandibular third molars: IAN block technique vs local infiltration technique
Design
Cross-over and single-blind, randomized clinical trial on 30 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
This study will be conducted in the Shahid Montazeri Clinic in Tehran city. Referral patients will be selected for wisdom tooth extraction who have wisdom teeth in the lower jaw on both sides. After providing the explanation and obtaining consent, the patients will randomly receive an infiltrate or block anesthesia injection for the first surgery. Injection type won't be shared with the patient and the evaluating researcher until the surgery is completed. In the second surgery, which will be performed at least three weeks later, anesthesia will be injected using the second method. The patient will be asked to discuss any discomfort with the surgeon. If the patient expresses pain, the surgery will be stopped and the anesthesia will be injected again according to the patient's condition, and the initial injection will be considered failed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with impacted lower jaw wisdom teeth
Exclusion criteria: patients with systemic disorders; patients using narcotic drugs; patients using sedatives; patients with active infection in the wisdom tooth area.
Intervention groups
In order to extract the wisdom teeth of the mandible in the patients included in the research, anesthesia injection will perform on one side by infiltration method and on the other side anesthesia injection will perform by block method.
Main outcome variables
Pain during injection; Pain during surgery; Delay of anesthesia onset in surgical field; Delay of anesthesia onset in mental area; Delay of anesthesia onset in lower lip
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221015056184N1
Registration date:2022-11-27, 1401/09/06
Registration timing:prospective
Last update:2022-11-27, 1401/09/06
Update count:0
Registration date
2022-11-27, 1401/09/06
Registrant information
Name
Mehdi Saberi Shakib
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 4151
Email address
mehdisaberishakib@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of two anesthetic methods with 2% lidocaine for the surgical removal of impacted mandibular third molars: IAN block technique vs local infiltration technique
Public title
A comparison of two anesthetic methods: IAN block technique vs local infiltration technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with symmetrical fully impacted lower third molars
Exclusion criteria:
patients with systemic disorders
drug consuming patients
patients taking antianxiety drugs
patients with active infection in the wisdom tooth area
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
lower impact third molar
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization will be done according to the random allocation rule. In this way, before the start of the study, people will be divided into two equal groups. The procedure will be that the numbers one to thirty written on paper are poured into a container and fifteen papers are removed. These fifteen selected numbers will form the members of the first group and the rest of the numbers will form the members of the second group. The first group will receive an infiltration injection in the first session and the second group will receive a block injection in the first session.
Blinding (investigator's opinion)
Double blinded
Blinding description
The volume of anesthetic injected on both sides is the same for each person. The anesthesia injection method is not discussed with the patient and the evaluating researcher until the end of the surgery.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of shahed university
Street address
Floor 13, Block A The central headquarters of the Ministry of Health, Medical Treatment and Education,Simaye Iran Ave., Qods Town
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.SHAHED.REC.1400.179
Health conditions studied
1
Description of health condition studied
Anesthesia effect of lidocaine solution in two methods: block and infiltration, in the posterior mandible
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Pain during anesthesia injection with infiltration method
Timepoint
Immediately after injection
Method of measurement
Visual Analogue Scale
2
Description
Pain during injection of anesthesia with block method
Timepoint
Immediately after injection
Method of measurement
Visual Analogue Scale
3
Description
Pain during surgery in infiltration anesthesia group
Timepoint
Immediately after surgery
Method of measurement
Visual Analogue Scale
4
Description
Pain during surgery in block anesthesia group
Timepoint
Immediately after surgery
Method of measurement
Visual Analogue Scale
5
Description
The delay in the onset of anesthesia in the surgical area, mental area, and lower lip in the infiltration anesthesia method.
Timepoint
One-minute intervals after anesthesia injection until the patient feels no pain
Method of measurement
Record the tissue numbing time after the injection
6
Description
The delay in the onset of anesthesia in the surgical area, mental area, and lower lip in the block anesthesia method.
Timepoint
One-minute intervals after anesthesia injection until the patient feels no pain
Method of measurement
Record the tissue numbing time after the injection
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In all the studied subjects, for the extraction of the wisdom teeth on one side of the lower jaw, anesthesia injection will perform by infiltration method. The solution to be used will be two carpules Lidocaine 2% with epinephrine 1 in 80000 manufactured by Loqman Company.
Category
Treatment - Surgery
2
Description
Control group: In all the studied subjects, for the extraction of the wisdom teeth that are hidden on one side of the lower jaw, anesthesia injection will perform by direct block (Halsted) method. The solution to be used will be two carpules Lidocaine 2% with epinephrine 1 in 80000 manufactured by Loqman Company.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Montazeri Dental Clinic
Full name of responsible person
Mahmoud Nasr Esfehani
Street address
No. 71, West Jafari Shari Ave., South Shahid Azodi Ave., Karim-Khan Ave.
City
Tehran
Province
Tehran
Postal code
1598759811
Phone
+98 21 8890 9388
Email
publicrelation@shahed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Nooshin Jalayer Naderi
Street address
No. 39, Italia St., Vesal Shirazi St., District 6
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
jalayer@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Mehdi Saberi Shakib
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 57, Vesal Shirazi Ave., Enghelab Eslami Ave.
City
Tehran
Province
Tehran
Postal code
1416863131
Phone
+98 21 6649 5118
Email
mehdisaberishakib@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mehdi Saberi Shakib
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 57, Vesal Shirazi Ave., Enghelab Eslami Ave.
City
Tehran
Province
Tehran
Postal code
1416863131
Phone
+98 21 6649 5118
Email
mehdisaberishakib@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mehdi Saberi Shakib
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 57, Vesal Shirazi Ave., Enghelab Eslami Ave.
City
Tehran
Province
Tehran
Postal code
1416863131
Phone
+98 21 6649 5118
Email
mehdisaberishakib@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
sex, age, anesthesia method, pain during injection, latency of anesthesia onset on surgical field, mental and lower lip, pain during surgery
When the data will become available and for how long
Access available 6 months after publication
To whom data/document is available
dental students and dentists
Under which criteria data/document could be used
The use of data is only allowed to know the research process and the accuracy of the content, and it is not allowed to use them for use in another study.
From where data/document is obtainable
Applicants should contact the following email address to receive data: mehdisaberishakib@gmail.com
What processes are involved for a request to access data/document
It will be possible to receive the data after the request through e-mail and authentication by providing the student number or pratitioner number