Evaluation of anesthetic efficacy of incisive nerve block with articaine 4% and epinephrine 1/200000 compared to inferior alveolar nerve block with lidocaine 2% and epinephrine 1/80000 during mandibular second premolar extraction
Evaluation of anesthetic efficacy of incisive nerve block with articaine 4% and epinephrine 1/200000 compared to inferior alveolar nerve block with lidocaine 2% and epinephrine 1/80000 during mandibular second premolar extraction
Design
A clinical trial with a parallel intervention group, double-blind, randomized, on 42 patients. The sampling method is random. Randomization is done using a table of random numbers.
Settings and conduct
Patients referred to the Faculty of Dentistry in Tabriz, who need the extraction of second premolar teeth on both sides of the lower jaw, will participate in the study. The extraction of the second premolar tooth on one side of the patient's jaw will be performed using the lidocaine lower block method. After a week, the second premolar tooth on the opposite side will be extracted with the articaine incisive block method. Three factors will be investigated: 1- time to reach anesthesia (lip anesthesia) 2- the need for repeated injection of anesthesia 3- measurement of pain level with visual scale Analogue Scale (VAS) immediately after extracting each tooth. Teeth extraction will be done in both stages by the same person and under the same conditions. The patient is aware of the type of treatment but does not know which side of the jaw will be used. The evaluating researcher will not know about the type of intervention performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients needing bilateral mandibular block injection to extract premolar teeth Exclusion criteria: sensitivity to anesthetics
Intervention groups
Intervention: Anesthesia with articaine 4% with epinephrine 1.200000 Control: Anesthesia with lidocaine with epinephrine 1.80000
Main outcome variables
Time to reach complete anesthesia
The need for additional anesthesia injection
The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230128057259N1
Registration date:2023-02-14, 1401/11/25
Registration timing:registered_while_recruiting
Last update:2023-02-14, 1401/11/25
Update count:0
Registration date
2023-02-14, 1401/11/25
Registrant information
Name
Mohammad Mokhtarvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 902 264 2040
Email address
amin.mokhtarvand1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-02, 1401/11/13
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of anesthetic efficacy of incisive nerve block with articaine 4% and epinephrine 1/200000 compared to inferior alveolar nerve block with lidocaine 2% and epinephrine 1/80000 during mandibular second premolar extraction
Public title
The dental anesthetic effect of articaine compared to lidocaine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Absence of systemic problem
Exclusion criteria:
Allergy to anesthetics
Pregnant or lactating women
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
One side of the jaw is used as control and the other side is used as intervention.
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling will be done among the patients referred to the Faculty of Dentistry in Tabriz who are eligible for the study. The randomization method is simple and its unit is individual. Our tool for randomizing a table of random numbers. These patients will have premolars for extraction (as similar as possible) on both posterior sides of the mandible. The right side of the first referring patient will be considered as the control (lidocaine), the left side as the case (articaine), and the opposite will be done in the second patient. Patients do not know the type of intervention on each jaw side.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind so the patients do not know about the type of intervention on each side of the jaw. The evaluating researcher will not know about the type of intervention performed. Patients know the type of material but do not know which side of the jaw will be used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research and Technology Vice-Chancellor,3rd Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht St., Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.TBZMED.REC.1401.590
Health conditions studied
1
Description of health condition studied
Dental problems
ICD-10 code
Z13.8
ICD-10 code description
Encounter for screening for other specified diseases and disorders
Primary outcomes
1
Description
Time to reach complete anesthesia
Timepoint
Immediately after the end of all injections
Method of measurement
Immediately after the end of all injections; The duration of lip numbness will be measured with the lip numbness index and by a stopwatch.
2
Description
The need for additional anesthesia injection
Timepoint
After starting the extraction
Method of measurement
After starting the extraction and in order to maintain complete anesthesia and painlessness of the patient during the tooth extraction, if necessary, an injection of supplementary anesthesia (pdl injection) will be performed. (Extract will not be performed until optimal anesthesia is achieved)
3
Description
The amount of pain
Timepoint
During tooth extraction
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Teeth will be numbed with incisive block anesthesia technique with articaine 4% along with epinephrine 1/200000 (dentacaine by Elixir company).
Category
Treatment - Other
2
Description
Intervention group: The tooth will be anesthetized by lower alveolar nerve block method with lidocaine 2% along with epinephrine 1/80000 (Prazocaine of Daropakhsh Company).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz
Full name of responsible person
Mohsen Hashemi
Street address
Faculty of dentistry, Tabriz university of medical sciences, Golgasht st. Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
mohsen.hashemi3263@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Soodabeh Kimyai
Street address
Faculty of dentistry, Tabriz university of medical sciences, Golgasht st. Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
soodabehkimyai@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohsen Hashemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Tabriz university of medical sciences, Golgasht st. Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
mohsen.hashemi3263@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohsen Hashemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Tabriz university of medical sciences, Golgasht st. Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
mohsen.hashemi3263@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohsen Hashemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Tabriz university of medical sciences, Golgasht st. Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
mohsen.hashemi3263@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
Not applicable
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