The aim of this study is to compare the success rate between the conventional and modified inferior alveolar nerve block techniques.
Design
The groups were considered as conventional (control) and modified (intervention). Coin randomization is performed to start and determine the initial position in every patient, and each patient (Single-blinded) selects one of the numbers between 1 and 2 (in different envelopes) as the injection method 2 is modified and 1 is conventional.
The sample size considered 42 persons.
Trial is a therapeutic type.
Settings and conduct
Referrals to the oral and maxillofacial Surgery department, Dentistry school, Islamic Azad University, Tehran, which have indication of anesthesia in both posterior mandibular teeth by Split-mouth and single blind (patients) method.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1 - Indication to block Inferior alveolar nerve for posterior mandibular tooth extractions bilaterally.
2 - Among 18 to 55 years-old
Exclusion criteria:
1 - Systemic diseases
2 - Infection and swelling in the area
3 - The anesthetic solutions sensitivity
4 - History of surgery or ramus fracture
5َ - Any analgesic
6 - Psychiatry disorders
Intervention groups
1 - conventional method
The syringe body is placed on the opposite premolars and needle enters ¾ anterior posterior distance from Coronoid process to pterygomandibular raphe.
2 - modified technique
The syringe body is placed on the occlusal of the first molar tooth on the opposite side and needle enters perpendicular to the medial mandibular ramus just lateral to the pterygomandibular fold.
In both methods, needle enters on 10 mm or so above the occlusal plane and parallel to it.
Main outcome variables
1 - The success rate of injection method
2 - Time to start numbness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150924024167N2
Registration date:2020-03-07, 1398/12/17
Registration timing:retrospective
Last update:2020-03-07, 1398/12/17
Update count:0
Registration date
2020-03-07, 1398/12/17
Registrant information
Name
Esshagh Lasemi
Name of organization / entity
Oral&Maxillofacial surgery Department-Dental Branch,Islamic Azad University,Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
e_lasemi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-10-07, 1398/07/15
Scientific title
Comparison of the effectiveness between conventional and modified inferior alveolar nerve block techniques
Public title
Comparing of effectiveness of two anesthetic techniques on inferior alveolar nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need the bilateral IANB for posterior mandibular tooth extractions.
Exclusion criteria:
Systemic diseases
Infection in the area
History of sensitivity reaction to the anesthetic solutions
History of surgery or fracture of the ramus
َAny medicament altering the pain perception
Psychiatry disorders
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
37
More than 1 sample in each individual
Number of samples in each individual:
2
One side of the mandible once, and then on the opposite side
Actual sample size reached:
42
More than 1 sample in each individual
Actual sample size in each individual:
2
One side of the mandible once, and then on the opposite side
Randomization (investigator's opinion)
Randomized
Randomization description
The study is performed using the split-mouth method (each side of the mandible as a group) and with the coin method, the starting position (left or right) will be selected for every patient; then each patient, without knowing which numbers correspond to any of the methods, chooses between 1 and 2 numbers in different envelopes (2 as modified and 1 as conventional) to get started.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are unaware of the type of anesthesia and side of mandible, which will be performed first.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical Sciences, Dental school
Street address
No.9, Neyestan 9th, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2017-02-27, 1395/12/09
Ethics committee reference number
IR.IAU.DENTAL.REC.1395, 25
Health conditions studied
1
Description of health condition studied
Indication of posterior teeth anesthesia in the form of bilateral
ICD-10 code
DA07.8
ICD-10 code description
DA07.8: An impacted tooth is a tooth that is all the way or partially below the gum line and is not able to erupt properly. Wisdom teeth (third molars) as the most commonly impacted teeth; DA0A.1: extraction or local periodontal disease.
Primary outcomes
1
Description
Comparison of success rates between conventional and modified technique in the inferior alveolar nerve block
Timepoint
During the intervention
Method of measurement
Inquiring from patient - Observing, Testing and Measuring by the Researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: as modified technique, a 1.8 cc Lidocaine 2% anesthetic solution with 1.80000 epinephrine is used. The syringe body is placed on the occlusal of the first molar on the opposite side, and needle enters perpendicular to the medial mandibular ramus just lateral to the pterygomandibular fold and needle enters on 10 mm or so above the occlusal plane and parallel to it. The techniques will be considered successful if the lip and tongue is anesthetized after 5 minutes and if did not happen for another 5 minutes the injection will be repeated one time more.
Category
Treatment - Other
2
Description
Control group: as conventional method, a 1.8 cc Lidocaine 2% anesthetic solution with 1.80000 epinephrine is used. The syringe body is placed on the opposite premolars and needle enters ¾ anterior posterior distance from Coronoid process to pterygomandibular raphe and with the line that is perpendicular to it from the tuberosity, and needle enters on 10 mm or so above the occlusal plane and parallel to it. The techniques will be considered successful if the lip and tongue is anesthetized after 5 minutes and if did not happen for another 5 minutes the injection will be repeated one time more.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and maxillofacial surgery department, school of dentistry, Islamic Azad university of medical s
Full name of responsible person
Esshagh Lasemi
Street address
No.9, Neyestan 9th, 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/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad university of medical science, school of dentistry
Full name of responsible person
Arash Azizi
Street address
No.9, Neyestan 9th, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2258 0925
Email
drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad university of medical science, school of dentistry
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
Islamic Azad University
Full name of responsible person
Esshagh Lasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
No.9, Neyestan 9th, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
elasemi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad university of medical science, school of dentistry
Full name of responsible person
Esshagh Lasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
No.9, Neyestan 9th, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
elasemi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad university of medical science, school of dentistry
Full name of responsible person
Esshagh Lasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
No.9, Neyestan 9th, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
elasemi@yahoo.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