Comparison of inferior alveolar nerve block (IANB) success rate in injection of two persocaine (lidocaine2%, epinephrine1/80000) cartridges with one cartridge for lower molars extraction
Inferior alveolar nerve block (IANB) anesthesia is a challenging technique that its primary reason is blind nature of this technique. One way for higher success rate is increasing anesthesia volume with use more number cartridge. In this study, 100 patients are randomly divided in two 50 numbers patients groups (group 1 involves patients with 2 carteridge injection and group 2 involves patients with one cateridge injection). In group 1, second injection will be done immediately after first injection. 0.2 ml of cartridge will be used for long buccal anesthesia in both groups. After 5 minutes, for anesthesia efficacy evaluation, we will use pin prick test with a probe on soft tissue of corner of inferior lip, mandibular body, anterior two third of lingual and floor of mouth mucosa. In the positive response to test, patient is named Failed case. In negative response, extraction will be done. As an alternative test, on the base of patient idea, painfulness or painlessness extraction will be considered as failure or success result.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022612610N1
Registration date:2013-04-11, 1392/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-11, 1392/01/22
Registrant information
Name
Seyed Hamed Jalalian Hashemy
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1241 4004
Email address
hamedjh59@zaum.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology of Zahedan University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of inferior alveolar nerve block (IANB) success rate in injection of two persocaine (lidocaine2%, epinephrine1/80000) cartridges with one cartridge for lower molars extraction
Public title
The success rate of inferior alveolar nerve block in injection of two persocaine cartridges compared with one cartridge in mandibular molars extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with mandibular molar teeth that can be remove with routine method; teeth without fascial space infection; patient with reliable psychology and patient with 18 to 60 years age.
Exclusion criteria: patients with systemic complications in ASA III Grouping and higher; patients who addicted to drug and alcohol and patients with systemic problems that have contraindication to epinephrine administration.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for Research and Technology, Zahedan University of Medical Sciences
Street address
University of Medical Sciense, Dr Hesabi square
City
Zahedan
Postal code
Approval date
2013-03-12, 1391/12/22
Ethics committee reference number
91_2085
Health conditions studied
1
Description of health condition studied
Extraction of posterior teeth
ICD-10 code
K08.1
ICD-10 code description
Loss of teeth due to accident, extraction or local periodontal disease
Primary outcomes
1
Description
Inferior Alveolar Nerve Block
Timepoint
5 minutes after injection
Method of measurement
Using a probe and Pin Prick test
Secondary outcomes
1
Description
Pain
Timepoint
during extraction
Method of measurement
patient idea
Intervention groups
1
Description
The use of two anesthetic cartridges
Category
Treatment - Drugs
2
Description
The use of one anesthetic cartridge
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Dental College
Full name of responsible person
Doctor Hamed Jalalian
Street address
Dental College, Tirandazi alley
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Mahmood Zade Sagheb
Street address
University of Medical Scienses, Dr Hesabi square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abasali Davarnia
Position
Dental Student
Other areas of specialty/work
Street address
Fajr dormitory, Dental College, Tirandazi alley
City
Zahedan
Postal code
9817699693
Phone
+98 54 1244 1824
Fax
Email
Abasalidavasrnia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Hamed Jalalian Hashemy
Position
Specialist in Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Tirandazi alley, Dental College, Asatid alley
City
Zahedan
Postal code
Phone
+98 54 1244 1814
Fax
Email
hamedjh59@yahoo.co.in
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Hamed Jalalian Hashemy
Position
Specialist in Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Tirandazi alley, Dental College, Asatid alley
City
Zahedan
Postal code
Phone
+98 54 1244 1814
Fax
Email
hamedjh59@yahoo.co.in
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)