Evaluation of the probability of neurosensory disturbance of inferior alveolar nerve (IAN) after IAN block with articaine compared with lidocaine
Design
The clinical trial is performed as randomized, blinded, and two arm parallel design of 1000 patients. The randomization was done by picking patients' names from matted pockets.
Settings and conduct
The study was performed on candidates for extraction of mandibular third molar in dentistry faculty of Shahid Beheshti university and its dependent dental clinics (Behfar and Ghazitabatabai clinics). Following taking an informed consent for extraction and the study, patients were seated on a dental unit, injection of the inferior alveolar nerve block was performed and after 15 minutes, the tooth was extracted. Patients were discharged after taking proper hygiene instructions.
Participants/Inclusion and exclusion criteria
Inclusion criteria consist of patients who need extraction of their erupted mandibular wisdom tooth that the apex has sufficient distance from inferior alveolar nerve canal and are systemically healthy and the patient age is between 15 to 60 years old. Exclusion critera is a history of surgery or trauma to the mandible
Intervention groups
The intervention group receives articaine for inferior alveolar nerve block.
The control group receives lidocaine for inferior alveolar nerve block
Main outcome variables
Incidence of neurosensory disturbance in inferior alveolar nerve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221203056693N1
Registration date:2023-03-02, 1401/12/11
Registration timing:registered_while_recruiting
Last update:2023-03-02, 1401/12/11
Update count:0
Registration date
2023-03-02, 1401/12/11
Registrant information
Name
Amir Mazidi Sharafabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2277 7437
Email address
Panahiniamahsa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Neurosensory disturbance following the inferior alveolar nerve block in the extraction of the third molars.
Public title
Comparison of Neurosensory disturbance following the inferior alveolar nerve block
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are in normal healthy status
Patients who need to remove mandibular third molars
Patients with a sufficient distance between the third molars root and the inferior alveolar nerve
Exclusion criteria:
Patients with disturbed inferior alveolar nerve
Patients with a history of fracture or trauma to mandible
Patients with history of surgery
Patients with a history of surgery of a mandibular pathologic lesion
Patients who have done cosmetic surgery or augmentation at mandible
Patients taking psychologic medications
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
1000
Randomization (investigator's opinion)
Randomized
Randomization description
The names of the patients were put in a pocket in separate papers and were taken out blindly and were devided into two groups alternatively.
Blinding (investigator's opinion)
Double blinded
Blinding description
The labels of the anesthetic cartridges were removed and marked by numbers 1 and 2. the cartridges were applicated neither the dentist nor the patient knowing the type of anesthetic solution. The patients were consented to participate in the study but not aware of the type of anesthetics. Evaluation of the neurosensory disturbances was done by an epidemiologist and the researcher to define statistical and clinical significance of difference, while both were unaware of the type of the anesthetic solution. In this study, patients, dentists, the data analyst, and the researcher were blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Neurosensory disturbance of inferior alveolar nerve
ICD-10 code
G50.9
ICD-10 code description
disorder of trigeminal nerve, unspecified
Primary outcomes
1
Description
Incidence of neurosensory disturbance
Timepoint
Evaluation of the neurosensory disturbance 24 hours, 1 week, 2 weeks, one and 4 months after the extraction
Method of measurement
Neurosensory evaluation was performed by brush test. Patients' eyes were covered and the chin area were brushed and the patients were asked about the direction of the brushing. the results were recorded as true or false.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Lidocaine 0.2% with epinephrine 1:80000 (Perzocaine - E, Darupakhsh, Tehran, Iran). For each patient, two 1.8 cc carpule were injected for inferior alveolar nerve block, each one in 45 seconds period. patients were undergone the procedure only once during the study.
Category
Prevention
2
Description
Intervention group: Articaine 4% with epinephrine 1:200000 (Dentacaine, Exir, Tehran, Iran).For each patient, two 1.8 cc carpule were injected for inferior alveolar nerve block, each one in 45 seconds period. patients were undergone the procedure only once during the study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti dental school
Full name of responsible person
Reza Tabrizi
Street address
Daneshjou Blvd, District 1, Tehran, Tehran Province,
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 912 623 4656
Email
amir.mazidi@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi ghasemi
Street address
Daneshjou Blvd, District 1, Tehran, Tehran Province,
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2242 1814
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mazidi Sharafabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Daneshjou Blvd, District 1, Tehran, Tehran Province,
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 912 623 4656
Email
amir.mazidi@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Tbrizi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjou Blvd, District 1, Tehran, Tehran Province,
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 912 585 0829
Email
tabmed@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mazidi Sharafabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Daneshjou Blvd, District 1, Tehran, Tehran Province,
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 912 623 4656
Email
amir.mazidi@ymail.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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts one month after the results are published
To whom data/document is available
The data will be accessible to allدر
Under which criteria data/document could be used
There is no special condition in this regard
From where data/document is obtainable
To receive the data, a request should be sent to the e-mail address of Dr. Mazidi at the address below:
amir.mazidi@ymail.com
What processes are involved for a request to access data/document
After sending the application to the mentioned E-mail address, the applicant will receive the information within 7 to 30 days