Investigating the effect of cooled anesthetic compared to increasing its volume on the success of inferior alveolar block anesthesia by articaine in mandibular first molars with symptomatic irreversible pulpitis: a randomized controlled clinical trial
Investigating the effect of cooled anesthetic compared to increasing its volume on the success rate of inferior alveolar block injection in mandibular first molars with symptomatic irreversible pulpitis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 135 patients.
Settings and conduct
Department of Endodontics, Tabriz Faculty of Dentistry
Patients will be randomly divided into 3 groups. During the injection, 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 VAS system. In each evaluation, VAS is divided into 4 parts: zero (no pain), VAS less than 54 mm (low pain), VAS between 55 and 114 (moderate pain) and VAS between 115 and 170 (severe pain). .
For blinding, VAS data collection will be done by the dental assistant blind to the patient group. Also, anesthesia injection and root canal treatment will be performed by two different dentists without knowing each other's work.
Participants/Inclusion and exclusion criteria
Patients with mandibular first molars with symptomatic irreversible pulpitis aged 18 to 65 years
Intervention groups
The first group will be injected with inferior alveolar block by articaine 4% with 1200,000 epinephrine kept at room temperature.
In the second group, anesthesia injection will be performed by the inferior alveolar block method with 4% articaine with 1200,000 epinephrine at a temperature of 4-6 degrees Celsius.
In the third group, anesthetic injection will be performed like the method of the first group with an anesthetic kept at room temperature. After anesthesia of the corner of the lip, the second carpool will be injected in the same way.
Main outcome variables
anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240518061836N1
Registration date:2024-05-23, 1403/03/03
Registration timing:prospective
Last update:2024-05-23, 1403/03/03
Update count:0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Bafrin Fattahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 168 2663
Email address
baf.fattahide@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-19, 1403/03/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cooled anesthetic compared to increasing its volume on the success of inferior alveolar block anesthesia by articaine in mandibular first molars with symptomatic irreversible pulpitis: a randomized controlled clinical trial
Public title
The effect of cooled anesthetic compared to increasing its volume on the success of inferior alveolar block anesthesia by articaine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients without systemic diseases
Patients aged 18-65 years
No facial paresthesia
Do not take analgesic drugs 6 hours before the treatment
Not taking drugs that interfere with anesthesia (tricyclic antidepressant-propranolol)
Absence of lesions and pathology in the anesthesia injection area
Absence of periodontal problems in the first molar area of the mandible
Patients with mandibular first molars with symptomatic irreversible pulpitis
Exclusion criteria:
Patients with congenital anomalies and structural defects in the first molar of the mandible
Patients undergoing radiotherapy or chemotherapy
Patients with an allergy to anesthetics
Patients taking painkiller, anti-inflammatory or sedative drugs in the last 12 hours
Smoker patients
Mandibular first molar tooth necrosis or irreversible pulpitis
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into three groups. In the first group, anesthesia injection will be performed by inferior alveolar block method by articaine 4% with 1200,000 epinephrine kept at room temperature. A 27 gauge sterile cartridge and syringe head will be used for injection. After entering the needle tip and aspiration, 1.8 cc of the solution is injected at a rate of 1 ml/min.
In the second group, anesthesia injection will be performed by the inferior alveolar block method with 4% articaine with 1200,000 epinephrine at a temperature of 4-6 degrees Celsius. A digital thermometer will be used to ensure the temperature of the anesthetic.
In the third group, anesthetic injection will be performed as in the first group with the anesthetic kept at room temperature. After anesthetizing the corner of the lip, the second carpool will be injected in the same way.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding the study, VAS (visual analogue scale) data collection will be done by the dental assistant without knowing the 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
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.TBZMED.REC.1402.964
Health conditions studied
1
Description of health condition studied
symptomatic irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
anesthesia
Timepoint
20 minutes after pulp anesthesia
Method of measurement
20 minutes after the injection, anesthesia is evaluated by electrical pulp test.
Secondary outcomes
1
Description
Pain
Timepoint
before injection and 20 minutes after injection
Method of measurement
Before anesthesia injection, the patients will be explained to rate their pain during the root canal treatment process using a visual analogue scale (VAS), with 0 cm indicating the absence of pain and 17 cm indicating the worst. 20 minutes after the injection, this assessment will be repeated and compared.
Intervention groups
1
Description
Intervention group: In the first group, anesthesia injection will be performed by inferior alveolar block method by articaine 4% with 1200,000 epinephrine kept at room temperature. A 27 gauge sterile cartridge and syringe head will be used for injection. After entering the needle tip and aspiration, 1.8 cc of the solution is injected at a rate of 1 ml/min.
Category
Prevention
2
Description
Intervention group: Anesthesia injection by inferior alveolar block method will be done by articaine 4% with 1200,000 epinephrine at a temperature of 4-6 degrees Celsius. A digital thermometer will be used to ensure the temperature of the anesthetic.
Category
Prevention
3
Description
Control group: Anesthesia will be performed in the same way as in the first group with anesthetic material kept at room temperature. After anesthesia of the corner of the lip, the second carpool will be injected in the same way.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sahar Shakuie
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 939 168 2663
Email
baf.fattahide@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Golgasht St, Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Vice Chancellor for Research and Technology
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
research-vice@tbzmed.ac.ir
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
Bafrin Fattahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz-Golgasht- Tabriz University of Medical Sciences- Faculty of Dentistry- Department of Endodontics
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 939 168 2663
Fax
Email
baf.fattahide@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bafrin Fattahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz-Golgasht- Tabriz University of Medical Sciences- Faculty of Dentistry- Department of Endodontics
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 939 168 2663
Fax
Email
baf.fattahide@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bafrin Fattahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz-Golgasht- Tabriz University of Medical Sciences- Faculty of Dentistry- Department of Endodontics
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 939 168 2663
Fax
Email
baf.fattahide@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
It will be published as a Persian and English article.
When the data will become available and for how long
From the time of publication of the articles onwards.
To whom data/document is available
public
Under which criteria data/document could be used
For use in studies with detailed citations.
From where data/document is obtainable
Dr. Bafrin Fatahi
What processes are involved for a request to access data/document