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Comparison of hemodynamic responses to epinephrine vasoconstrictor during infra alveolar nerve block and Gow-Gates mandibular anesthesia: A clinical trial

Protocol summary

Study aim
compare the hemodynamic responses to the vasoconstrictor epinephrine in two techniques of local anesthesia injection: the Gow-Gates (GG) technique and the inferior alveolar nerve block (IANB)
Design
A clinical trial with a control group, with parallel groups, double blinded, randomized, phase 2 on 20 patients.
Settings and conduct
20 candidates for bilateral extraction of mandibular third molar teeth participated. Before surgery, their characteristics including age and gender and their vital signs including heart rate (HR), oxygen saturation level, systolic blood pressure (SBP) and diastolic blood pressure (DBP) and ECG using a hospital monitoring device 5 minutes before the injection. was registered Randomly, lidocaine 2% and epinephrine 1:100,000 were extracted for the first tooth under GG injection and the second tooth under IANB injection. The mentioned hemodynamic variables were measured immediately, 2, 5, 10, 15 and 20 minutes after injection of anesthetic. Finally, after completing all the measurements, the patient's wisdom tooth removal surgery was performed.
Participants/Inclusion and exclusion criteria
Entry criteria: Candidates for bilateral surgery of asymptomatic mandibular impacted third molar teeth Agreement to participate in the study Exit criteria: History of systemic disease History of odontogenic pains in the last 7 days
Intervention groups
Intervention group one: Gow-Gates injection technique Intervention group two: IANB injection technique (control)
Main outcome variables
The hemodynamic changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241004063259N1
Registration date: 2024-12-08, 1403/09/18
Registration timing: retrospective

Last update: 2024-12-08, 1403/09/18
Update count: 0
Registration date
2024-12-08, 1403/09/18
Registrant information
Name
Fardin Khodadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5453 5298
Email address
fardinkh.work@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-11, 1403/07/20
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic responses to epinephrine vasoconstrictor during infra alveolar nerve block and Gow-Gates mandibular anesthesia: A clinical trial
Public title
Comparison of hemodynamic responses to epinephrine vasoconstrictor during infra alveolar nerve block and Gow-Gates mandibular anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for bilateral surgery of asymptomatic mandibular impacted third molar teeth Agreement to participate in the study
Exclusion criteria:
History of systemic disease History of odontogenic pains in the last 7 days
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
More than 1 sample in each individual
Number of samples in each individual: 2
In the present clinical trial, in order to investigate the effect of interventions, in each patient, by the split-mouth method, the impacted third molar teeth of the mandible on each side were randomly injected with lidocaine along with epinephrine with two techniques, IANB and GG.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using a sealed envelope and patient selection. In this way, firstly, 2 envelopes, each containing one of the following (right, left) are provided to each patient and the patient selects only one of them. Then, 2 other envelopes, each containing one of the following (IANB and Gow-Gates), are provided to the patient and the patient selects one of them again. According to the study design, the side and type of the first technique are randomized and once the technique and side used are specified, the technique on the other side is also specified.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients were not aware of the technique used to inject anesthesia for each tooth (but they were aware of the general techniques used by IANB and Gow-Gates) and the researcher was not involved in measuring the investigated variables. Also, statistical analyzer was blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
No. 7.2 , Qaem Maqam Ave, Farhang Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188934339
Approval date
2024-10-05, 1403/07/14
Ethics committee reference number
IR.NKUMS.REC.1403.046

Health conditions studied

1

Description of health condition studied
Hemodynamic responses
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changes in hemodynamic variables
Timepoint
5 minutes before, 2, 5, 10, 15 and 20 minutes after injection
Method of measurement
Using a hospital monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: injection of local anesthesia with the Gow-Gates method
Category
Treatment - Surgery

2

Description
Intervention group: injection of local anesthesia with the Infra Alveolar Nerve Block method
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
North Khorasan Faculty of Dentistry
Full name of responsible person
Fardin Khodadadi
Street address
No. 7.2, Qaem Maqam22 Ave, Farhang Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188934339
Phone
+98 51 5453 5298
Email
fardinkh.work@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Vahide Motamed Sanaye
Street address
No. 25, Shahid Square
City
Bojnurd
Province
North Khorasan
Postal code
9188934339
Phone
+98 58 3151 3303
Email
motamedv871@gmail.com
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
Fardin Khodadadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
NO. 7.2, Qaem Maqam22 Ave, Farhang Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188934339
Phone
+98 51 5453 5298
Email
fardinkh.work@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Ehsan Amini
Position
Non-faculty specialist dentist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 25, Shahid Square
City
Bojnurd
Province
North Khorasan
Postal code
9188934339
Phone
+98 58 3151 3303
Email
ehsunamini@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Fardin Khodadadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 7.2, Qaem Maqam22 Ave, Farhang Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188934339
Phone
+98 51 5453 5298
Email
fardinkh.work@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
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
Title and more details about the data/document
All conditions and results of this study will be available to everyone in the form of an article.
When the data will become available and for how long
Access starts 3 months after results are published
To whom data/document is available
The data of this study will be available to everyone.
Under which criteria data/document could be used
It will be possible to use the results of this study for clinical use as well as to use it in future studies by mentioning the source.
From where data/document is obtainable
It will be announced in the future.
What processes are involved for a request to access data/document
It will be announced in the future.
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