Comparison of the success rate of two anesthetic techniques using lidocain 2% in mandibular first premolars with symptomatic irreversible pulpitis
Design
A clinical trial with a parallel intervention group, double-blind, randomized, on 90 patients. The sampling method is random. Randomization is done using a table of random numbers.
Settings and conduct
90 patients referred to the endodontics department of the Faculty of Dentistry in Tabriz, suffering from symptomatic irreversible pulpitis in the mandibular first premolar teeth, will be included in the study based on the inclusion criteria. Patients will be randomly divided into two groups. Anesthesia injection will be done by lidocaine 2% along with epinephrine 1:80000. In the first group, anesthesia will be injected by the inferior alveolar block method, and in the second group by the buccal infiltration method (0.9 cc Carpol) along with the periodontal ligament (0.9 cc Carpol). While creating the access hole and entering the pulp chamber and entering the root canal, the success rate of anesthesia will be evaluated by the Visual Analogue Scale (VAS). The data collector and the treatment provider do not know the type of patient group.
Participants/Inclusion and exclusion criteria
Inclusion: Patients with mandibular first premolar with symptomatic irreversible pulpitis. Average (55-144mm) and severe (115-170mm) vas criteria before treatment
Exclusion: patients using painkillers, anti-inflammatory or sedative drugs in the last 12 hours, failure to achieve lip numbness after 15 minutes of block injection
Intervention groups
Intervention 1: Inferior alveolar block anesthesia
Intervention 2: Anesthesia by buccal infiltration method along with periodontal ligament
Main outcome variables
The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230301057581N1
Registration date:2023-03-07, 1401/12/16
Registration timing:registered_while_recruiting
Last update:2023-03-07, 1401/12/16
Update count:0
Registration date
2023-03-07, 1401/12/16
Registrant information
Name
Maryam Fereydoonzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 4586
Email address
maryamfereydoonzadeh1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-05, 1401/12/14
Expected recruitment end date
2023-04-26, 1402/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success rate of two anesthetic techniques using lidocain 2% in mandibular first premolars with symptomatic irreversible pulpitis
Public title
The effect of types of dental anesthesia with lidocaine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No systemic diseases
No facial paresthesia
Not taking drugs that interfere with anesthesia
Absence of periodontal problems in the second premolar region of the mandible
Exclusion criteria:
Patients with congenital anomalies and structural defects in premolar teeth
Patients undergoing radiotherapy or chemotherapy
Patients with an allergy to anesthetics
Smoking patients
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
90
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 randomization is a table of random numbers. Based on this, the type of treatment is marked with code A (anesthetic injection by inferior alveolar block method) and B (buccal infiltration method) and placed inside the sealed envelopes. take Then the envelopes are placed in a bag and mixed. Then it is randomly selected from the bag and treatment is given to the patient by observing the code. None of the patients will be informed about the treatment of another patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, and data collection will be done by a dental assistant without knowing the type of patient group. Also, anesthesia injection and root canal treatment will be performed by two different dentists without knowing each other's work.
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
Tabriz University of Medical Sciences, Golgasht St.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.TBZMED.REC.1401.995
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
The amount of pain
Timepoint
During root canal treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Anesthesia injection will be done by lidocaine 2% along with epinephrine 1:80000. In this group, the first injection of anesthesia will be by the inferior alveolar block method.
Category
Treatment - Other
2
Description
Intervention group: Anesthesia injection will be done by lidocaine 2% along with epinephrine 1:80000. In this group, the first anesthetic injection will be by buccal infiltration method (0.9 cc carpol) along with inside the periodontal ligament (0.9 cc carpol).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz
Full name of responsible person
Nagin Ghasemi
Street address
Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
neginghasemi64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Soudabeh Kimeyaei
Street address
Tabriz University of Medical Sciences, Golgasht St
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
Nagin Ghasemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
neginghasemi64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nagin Ghasemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
neginghasemi64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nagin Ghasemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
neginghasemi64@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