Evaluation of anesthetic solution temperature effect on success of pulpal anesthesia following inferior alveolar nerve block injection in teeth with symptomatic irreversible pulpitis
Determination of the effect of anesthetic solution temperature on the success of pulpal anesthesia due to injection of inferior alveolar nerve block in teeth with symptomatic irreversible pulpitis
Design
The clinical trial consisted of three intervention groups, with parallel, single-blind, randomized groups. Excel software rand function is used for randomization.
Settings and conduct
This study is performed in the field of dental treatment in Bojnourd Dental School. 60 patients are randomly divided into three groups and each group receives anesthesia solution at one of the temperatures of 4, 20 and 37 ° C as a inferior alveolar nerve block. Prior to the injection, cold and electrical tests are taken from the tooth to make sure the tooth is vital. 15 minutes after the injection, cold, electrical and VAS tests are taken from the patient and the success of anesthesia is evaluated.
Participants/Inclusion and exclusion criteria
No entry condition:
Alcohol or drug addiction or smoking
Taking psychiatric drugs
Has a systemic disease affecting the dental treatment plan
Patients taking painkillers on the day of injection
Has calcification in the pulp and canal of the desired tooth
Patients who do not show signs of onset of lip anesthesia with a single inferior nerve block injection
History of dentoalveolar trauma
Entry condition:
Presence of mandibular molars with irreversible pulpitis
Adults over 18 years
Patient permission
Intervention groups
Patients are randomly divided into three groups and in each group receive an inferior alveolar nerve block injection with one of the temperatures of 4, 20 and 37 ° C.
Main outcome variables
pulpal anesthesia
response to cold test
response to heat test
response to electrical test
verbal analogue scale
age
sex
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201109049322N1
Registration date:2020-12-18, 1399/09/28
Registration timing:registered_while_recruiting
Last update:2020-12-18, 1399/09/28
Update count:0
Registration date
2020-12-18, 1399/09/28
Registrant information
Name
Ali Farahnejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 7010
Email address
afnphenomenon@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-16, 1399/08/26
Expected recruitment end date
2021-02-14, 1399/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of anesthetic solution temperature effect on success of pulpal anesthesia following inferior alveolar nerve block injection in teeth with symptomatic irreversible pulpitis
Public title
Clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence a mandibular molar with symptomatic irreversible pulpitis
Adults over 18 years old
Patient permission
Exclusion criteria:
Patients who are alcohol or drug addicted or smoking
Patients who are taking psychiatric drugs
Patients who have a systemic disease affecting the dental treatment plan
Patients who are taking painkillers on the day of injection
Teeth which have calcification in the pulp and canal of the desired tooth
Patients with history of dentoalveolar trauma
Patients who do not have any symptom of lip numbness after a single inferior nerve block injection
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced (permuted) block randomization
(For example, if a, b, and c are our three groups, they are divided this way: baccab, cbbaca, ...)
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants and data analyzers were kept blind in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bojnurd university of medical sciences
Street address
The central building of North Khorasan University of Medical Sciences, Dolat Blvd.
City
Bojnurd
Province
North Khorasan
Postal code
7487794149
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.NKUMS.REC.1399.069
Health conditions studied
1
Description of health condition studied
Inferior alveolar nerve block anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Response to the electrical test
Timepoint
Before anesthesia injection - 15 minutes after anesthesia injection - 1 minute after the last test
Method of measurement
via electrical pulp tester
2
Description
Response to the cold test
Timepoint
Before anesthesia injection - 15 minutes after anesthesia injection - 1 minute after the last test
Method of measurement
Based on the standard cold test method for dental vitality testing
3
Description
Response to the Verbal Analog Scale
Timepoint
When preparing the access cavity
Method of measurement
Based on the patient's verbal response
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Anesthesia injection at a temperature of 37 ° C
Category
Treatment - Devices
2
Description
Intervention group: Anesthesia injection at a temperature of 4 ° C
Category
Treatment - Devices
3
Description
Control group: Anesthesia injection at a temperature of 20 ° C
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized clinic of Bojnourd Dental School
Full name of responsible person
Mahsa Dastpak
Street address
School of Dentistry, Near Imam Hassan Hospital, Arkan Road
City
Bojnurd
Province
North Khorasan
Postal code
94176-94735
Phone
+98 58 3229 6764
Email
INFO@NKUMS.AC.IR
Web page address
http://nkums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Kaveh Hojjat
Street address
Shahriar St., above Imam Ali Hospital, School of Medicine, Vice Chancellor for Research and Technology
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 6764
Fax
Email
INFO@NKUMS.AC.IR
Web page address
http://nkums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Mahsa Dastpak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, south side of Imam Ali Hospital, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6764
Email
mahsa.dastpak@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mahsa Dastpak
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, south side of Imam Ali Hospital, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6764
Email
mahsa.dastpak@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Ali Farahnejad
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, south side of Imam Ali Hospital, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6764
Email
afnphenomenon@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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available