Comparison of the effectiveness of 2 substances 4% articaine and 3% mepivacaine on palatal Anesthesia by posterior superior alveolar nerve block on posterior of maxilla
Comparison of efficacy of PSA injection of 4% Articaine with 3% Mepivacaine on palatal anasthesia in posterior of maxilla
Design
The research is based on the design of a split mouth randomized single-blind clinical trial
Settings and conduct
4% Articaine with 1:100000 epinephrine and 3% Mepivacaine are both made by Elixir factory, 5 minutes after the anesthetic was injected, greater palatine injection done for comparising palatal anesthesia and pain recorded in VAS system
Participants/Inclusion and exclusion criteria
People between the ages of 18-35. Complete patient consent to participate in the study Those who have bilateral mandibular third molar surgery are indicated for block injection on both sides of the mandible. No entry conditions: Systemic and neurological diseases. Allergy to sulfite (allergic asthma) or local anesthetic. Smoking, alcohol, drugs. Any acute infection and swelling
Intervention groups
Intervention group 1: A posterior of maxilla side that receives articaine anesthesia Intervention group 2: The other side of the posterior of maxilla that receives mepivacaine anesthesia
Main outcome variables
Comparison of articaine with mepivacaine in PSA nerve block in extraction of posterior teeth of maxilla
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170307032929N5
Registration date:2021-02-23, 1399/12/05
Registration timing:registered_while_recruiting
Last update:2021-02-23, 1399/12/05
Update count:0
Registration date
2021-02-23, 1399/12/05
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
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of 2 substances 4% articaine and 3% mepivacaine on palatal Anesthesia by posterior superior alveolar nerve block on posterior of maxilla
Public title
Comparison of the effectiveness of 2 substances articaine and mepivacaine on palatal Anesthesia by posterior superior alveolar nerve block on posterior of maxilla
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People older than 18 years old
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
N/A
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
Maxilla posterior teeth on both side of the jaw
Randomization (investigator's opinion)
Randomized
Randomization description
The maxillary quadrants were divided into case and control groups, and one of the two test solutions was randomly injected into each individual during one or two visits on each side of the maxilla. In each sample, articaine and mepivacaine were injected one by one to the left and right, so that if you injected articaine to the left in the first patient, we injected articaine to the right in the second patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was performed on 20 eligible individuals who participated in the study with complete satisfaction. They were informed that two approved anesthetics would be used in their surgery. The surgeon, examiner, and patient were unaware of any type of injection but the injector was aware, Pain during greater palatine injection from the patient is recorded by the researcher in the form related to the patient code
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad Univercity Tehran dental Branch
Street address
10th Neistan, 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.1399.202
Health conditions studied
1
Description of health condition studied
Removal of posterior maxillary teeth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Palatal Anesthesia
Timepoint
5 minutes after PSA block injection
Method of measurement
After 5 minutes with greater palatine injection, the paine has been recorded in VAS system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:a part of the posterior of the maxilla that receives 4% articaine anesthesia with epinephrine 1: 100000 and is produced by the elixir factory by PSA nerve block method during the session.
Category
Treatment - Surgery
2
Description
Intervention group: a part of the posterior of the maxilla that receives 3% Mepivacaine anesthesia with epinephrine 1: 100000 and is produced by the elixir factory by PSA nerve block 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
Zeinab Boushehrian
Street address
No. 4, paydarfard street, Araghi St., Tehran
City
Tehran
Province
Alborz
Postal code
3149648599
Phone
+98 26 3255 5110
Email
www.z.nagisa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No. 9, Pasdaran St., 9th Neystan
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drarashazizi@yahoo.com
Web page address
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
Medical doctor
Other areas of specialty/work
Dentistry
Street address
10th Neistan St, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 912 201 5179
Fax
+98 21 8977 5567
Email
f_navi@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeinab Boushehrian
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
1478676641
Phone
+98 21 4431 1450
Email
www.z.nagisa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeinab Boushehrian
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
1478676641
Phone
+98 21 4431 1450
Email
www.z.nagisa@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