Objectives: The comparison of effectiveness of inferior alveolar nerve block with and without use of panoramic radiography. Design: Randomized clinical trial. Setting and conduct: In this study, 31 patients referring for extraction of bilateral mandibular molar teeth in maxillofacial department of tabriz faculty of dentistry will be chosen. Case side will be chosen randomly, All anesthesias will be done by the same surgeon. In this study for each patient 2 IANB injections will be done in separate days that one of these injections in one side will be done routinely without using of panoramic radiography(control group) but the second injection in the opposite side will be done with using of panoramic radiography(test group). In test group the most anterior and superior point of mandibular foramen (MF) is detected and the occlusal plan is plotted and the distance between MF point and occlusal plan is measured. Needle penetration depth and other stages will be the same as the control group. Participants including major eligibility criteria: Patients with bilateral mandibular posterior molar teeth for extraction and having panoramic radiography that has been taken in the past 6 mounts will be included and patients with limited jaw opening and trismus and history of any systemic diseases will be excluded. Interventions: One side anesthesia will be done routinely without using of panoramic radiography and for the other side with MF determination by panoramic radiography. Main outcome measures(variables): The effectiveness of anesthesia of posterior teeth will evaluate by electric pulp tester after 10 minutes, positive results will be the sign of failure of injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040610935N3
Registration date:2013-04-22, 1392/02/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-22, 1392/02/02
Registrant information
Name
Mohammad Ali Ghavimi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 6147
Email address
ghmd@irimc.org
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-05-02, 1392/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effectiveness of inferior alveolar nerve block with and without mandibular foramen determination by panoramic radiography
Public title
The comparison of effectiveness of inferior alveolar nerve block with and without mandibular foramen determination by panoramic radiography
Purpose
Treatment
Inclusion/Exclusion criteria
Major Inclusion criteria: Indication for bilateral mandibular molar teeth extraction; People who are physically and mentally healthy and able to express their pain; People who have panoramic radiography for dental treatment in the past 6 months. Major Exclusion criteria: Don't have a panoramic radiography; people who the using of routine dental cartridges containing epinephrine are contraindicated; Using of mental anesthesia or other anesthesia; History of any systematic disease; Patients with limited jaw opening and trismus.
Age
From 19 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of medical sciences and health services
Street address
Golgasht St, Azadi Ave
City
Tabriz
Postal code
5166414766
Approval date
2013-03-16, 1391/12/26
Ethics committee reference number
01222
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Anesthetic success
Timepoint
10 minutes after injection
Method of measurement
Electric pulp tester
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Inferior alveolar nerve block with mandibular foramen determination by panoramic radiography
Category
Treatment - Other
2
Description
Control: Inferior alveolar nerve block without the use of panoramic radiography
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistry, Tabriz university of medical sciences
Full name of responsible person
Dr.Mohammad Ali Ghavimi
Street address
Golgasht St, Azadi Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences vice chancellor for research
Full name of responsible person
Seyed Kazem Shakouri
Street address
Golgasht St, Azadi Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university of medical sciences vice chancellor for research
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
Tabriz faculty of Dentistry, Tabriz university of medical sciences
Full name of responsible person
Dr. Mohammad Ali Ghavimi
Position
DDS Oral and Maxillofacial surgery
Other areas of specialty/work
Street address
Golgasht St, Azadi Ave
City
Tabriz
Postal code
Phone
+98 41 1553 6078
Fax
Email
ghavimim@Gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz faculty of Dentistry, Tabriz university of medical sciences
Full name of responsible person
Dr. Mohammad Ali Ghavimi
Position
DDS Oral and Maxillofacial surgery
Other areas of specialty/work
Street address
Golgasht St, Azadi Ave
City
Tabriz
Postal code
Phone
+98 41 1553 6078
Fax
Email
ghavimim@Gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz faculty of Dentistry, Tabriz university of medical sciences
Full name of responsible person
Dr. Mohammad Ali Ghavimi
Position
DDS Oral and Maxillofacial surgery
Other areas of specialty/work
Street address
Golgasht St, Azadi Ave
City
Tabriz
Postal code
Phone
+98 41 1553 6078
Fax
Email
ghavimim@Gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)