En Comparison of success of inferior alveolar nerve block with and without digital panoramic radiography
Design
One-blind, stratified random clinical trial based on jaw side on 53 patients by split mouth
Settings and conduct
53 patients with inclusion and exclusion criteria enter the study among the patients referred to the surgery department of Dental Branch of Islamic Azad University of Tehran. Using the table of random numbers, the side of the jaw to be injected is determined and the injection is done without radiography. next step, the injection of the opposite side is performed using radiography and determine the position of the mandibular foramen related to the occlusal plan. Patients are blinded to injection on each side and finally the results of the two methods are compared
Participants/Inclusion and exclusion criteria
Patients over 18 years, indication of bilateral mandibular block, the power to understand and express the sense, to have digital panoramic radiography, presence of at least two posterior teeth on each side of mandible, non contraindication to the use of routine carpol containing epinephrine, not use other anesthesia methods along with the mandibular block, not restriction of mouth opening and trismus, not having an infection at the injection site
Intervention groups
Case Group: Injection of inferior alveolar nerve block using radiography Control group: Injection of inferior alveolar nerve block without radiography on the opposite side
Main outcome variables
Tingling of lower lip and chin, onset time of anesthesia
General information
Reason for update
Acronym
IANB
IRCT registration information
IRCT registration number:IRCT20210119050080N2
Registration date:2021-02-11, 1399/11/23
Registration timing:prospective
Last update:2021-02-11, 1399/11/23
Update count:0
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
Eshagh Lasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
elasemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of success of inferior alveolar nerve block with and without digital panoramic radiography
Public title
Comparison of success of inferior alveolar nerve block with and without digital panoramic radiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years
Indication of bilateral mandibular block
The power to understand and express the sense
To have digital panoramic radiography
Presence of at least two posterior teeth on each side of mandible
Exclusion criteria:
Contraindications to the use of routine carpol containing epinephrine
Use other anesthesia methods along with the mandibular block
Restriction of mouth opening and trismus
To have not digital panoramic radiography
Having an infection at the injection site
Patient's dissatisfaction to enter the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
53
More than 1 sample in each individual
Number of samples in each individual:
2
One side of the patient's mandible as the control group and the opposite side as the case group receives the intervention test.
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is stratified based on jaw side. Using random numbers table, it is determined which side of each patient's jaw (right or left) to inject first. Then, in order to prevent bias, injection is performed without using the digital panoramic radiography guide on the side specified by random numbers table. And on the opposite side, injection is performed using a digital panoramic radiography guide.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in this study will be blinded to which side of the jaw receives the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dental School, Islamic Azad University of medical science of Tehran
Street address
No.9, Neiestan9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-12-14, 1399/09/24
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.236
Health conditions studied
1
Description of health condition studied
Success of inferior alveolar nerve block
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tingling of lower lip and chin
Timepoint
Immediately after injection
Method of measurement
Ask the patient
Secondary outcomes
1
Description
Onset of anesthesia
Timepoint
Immediately after injection
Method of measurement
chornometer
Intervention groups
1
Description
Intervention group: Determination of upper anterior position of mandibular foramen on digital panoramic radiography And calculate the distance to the occlusal plan using a caliper. specify the same distance inside the patient's mouth and perform the injection
Category
Treatment - Other
2
Description
Control group: Confluence Location of horizontal line passes from deepest point of pterygomandibular raphe to vertical line passes from tree quarters of anterior of ramus Determines where the needle enters the inner surface of Ramus. Slowly insert the needle into the tissue to reach the bone stop. The average depth of needle entry is 20 to 25 millimeter .After dealing with the bone, pull out the needle by 1 millimeter and After aspiration, inject 1.5 milliliter of anesthetic solution in 60 seconds.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgery, Faculty of Dentistry, Islamic Azad University of Tehran
Full name of responsible person
Dr Eshagh Lasemi
Street address
No.9, Neiestan9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Elasemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Arash Azizi
Street address
No.9, neiestan9 Ave, pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
elasemi@yahoo.com
Web page address
http://dental.iautmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Dr Eshagh Lasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Neiestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
elasemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Eshagh Lasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, Neiestan9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
sa1373724@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Eshagh Lasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, neiestan9 Ave, pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
sa1373724@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
A part of the information, such as information on the main outcome, can be shared.
When the data will become available and for how long
The start of the access period will be 6 to 12 months after the results are released
To whom data/document is available
Data will only be available to researchers working in academic institutions.
Under which criteria data/document could be used
Data will be available for dental research centers, universities and public private health centers. All clinicians using inferior alveolar nerve block in order to dental procedure are allowed to use the docummentation.
From where data/document is obtainable
Applicants can contact the person responsible for the article to receive the information.
Dr Eshagh Lasemi, elasemi@yahoo.com 00989123871430
No9, Neistan9 Ave, Pasdaran Ave, Tehran
What processes are involved for a request to access data/document
Demand by email to the person responsible for the article
elasemi@yahoo.com