Comparison of efficacy of infiltration injection of 4% Articaine with 3% Mepivacaine on lingual anasthesia in anterior of mandible
Design
The research is based on the design of a split mouth randomized single_blind clinical trial. The clinical trial has a control group, with parallel groups, single_blind, approved, phase 3 on 20 patients. Left and right were injected in a every other one method.
Settings and conduct
4% Articaine with 1:100000 epinephrine and 3% Mepivacaine are both make by Exir factory, 5 minutes after the anesthetic is injecting, decollation of lingual region is doing for comparising lingual anesthesia and pain recorded in VAS system .
The study is performing in the surgery department of the School of Dentistry of the Islamic Azad University
Participants/Inclusion and exclusion criteria
Inclusion criteria: People older than 18 years; patient consent; bilateral mandibular anterior extraction indicated for infiltration injection on both sides of the mandible. Exclusion criteria: Systemic and neurological diseases; Allergy to sulfite (allergic asthma) or local anesthetic; Smoking; alcohol or drug use; Any acute infection and swelling.
Intervention groups
Intervention group 1: one side of anterior of mandible that receives articaine anesthesia Intervention. group 2: The other side of the anterior of mandible that receives mepivacaine anesthesia
Main outcome variables
The amount of pain in the anterior lingual region of the mandible while decollattion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170307032929N4
Registration date:2021-02-16, 1399/11/28
Registration timing:prospective
Last update:2021-02-16, 1399/11/28
Update count:0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Fina Navi
Name of organization / entity
Islamic Azad University Tehran Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 912 201 5179
Email address
f_navi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-23, 1399/12/05
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparidon of the effectiveness of 4% articaine and 3% mepivacaine on lingual anesthesia by infiltration injection
Public title
Comparidon of the effectiveness of articaine and mepivacaine on lingual anesthesia by infiltration injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People older than 18 years
Complete patient consent to participate in the study.
Those in whom upper posterior teeth is bilaterally indicated. Indication of PSA block injection on both sides of the maxilla
Exclusion criteria:
Systemic and neurological diseases.
Allergy to sulfite (allergic asthma) or local anesthetic.
Smoking, alcohol, drugs.
Any acute infection and swelling
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Mandibular anterior teeth on both sides of jaw
Randomization (investigator's opinion)
Randomized
Randomization description
The mandibular quadrants is dividing into case and control groups, and one of the two test solutions is randomly injecting on each side of the mandible. In each sample, articaine and mepivacaine is injecting one by one to the left and right, so that if you inject articaine to the left in the first patient, we inject articaine to the right in the second patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
The surgeon, examiner, and patient are unaware of any type of injection but the injector is aware, blinding is done by lottery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Tehran Dental Branch
Street address
9th Neystan,Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-11-04, 1399/08/14
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.200
Health conditions studied
1
Description of health condition studied
Extraction of anterior teeth of mandibular
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lingual anesthesia
Timepoint
Immediately after infiltration
Method of measurement
After infiltration injection, with decollation of lingual region the pain is recorded in VAS system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:a part of the anterior of the mandible that receives 4% articaine anesthesia with epinephrine 1: 100000 and is produced by the elixir factory by infiltration method during the session.
Category
Treatment - Surgery
2
Description
Intervention group: a part of the anterior of the mandible that receives 3% Mepivacaine anesthesia with epinephrine 1: 100000 and is produced by the exir factory by infiltration method during the session.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Islamic Azad University of Medical Sciences Dental Branch Faculty of dentistry–Department of
Full name of responsible person
Ehsan Daneshmandi
Street address
No. 4, paydarfard street, Araghi St., Tehran
City
Tehran
Province
Tehran
Postal code
3149648599
Phone
+98 21 2631 6247
Email
www.ehda72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Arash Azizi
Street address
No. 9, Pasdaran St., 9th Neyestan, Tehran Town
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran islamic Azad university of medical sciences dental branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Fina Navi
Position
Oral And Maxillofacial Surgeon
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neystan,Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
F_navi@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Daneshmandi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 4, Paydarfard Street, Araghi Street, Tehran
City
Tehran
Province
Tehran
Postal code
3149648599
Phone
+98 26316247
Email
www.Ehda72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Daneshmandi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 4, Paydarfard Street, Araghi Street, Tehran
City
Tehran
Province
Tehran
Postal code
3149648599
Phone
+98 26 316247
Email
www.Ehda72@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
Participants' data file, consent form (after ensuring that individuals are not identified), number one and two information form, research method, statistical analysis and related tables will be shared
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions will also be available, as well as people working in industry
Under which criteria data/document could be used
Access to information forms is only possible for researchers in this field
From where data/document is obtainable
Researcher Mr. Ehsan Daneshmandi contact number:9124128581 Adress:No.4, paydarfard street, Araghi street, tehran Email:www.ehda72@gmail.com
What processes are involved for a request to access data/document
Request via Email to be reviewed and the result will be communicated to them within a maximum of one week