Anaesthetic efficiency of supplemental infiltration of retromolar pad after inferior alveolar nerve block in mandibular first molars with symptomatic irreversible pulpitis.
Measuring the sufficiency of retromolar pad infiltration after inferior alveolar nerve block
Design
In this study 50 patients with spontaneous pain and irreversible pulpitis of mandibular first molar referring to dental university were chosen.
Settings and conduct
This study is doing in Shiraz Azad Dental University.Each patient get checked to be in our inclousion criteria,then inform consent will given.
Participants/Inclusion and exclusion criteria
Exclusion criteria: younger than 18 years, allergic to local anesthetics or sulfites, pregnancy, history of significant medical conditions, taking any medications like over-the-counter painkillers, sedatives, anti-anxiety or antidepressant medications that may affect pain assessment active sites of Pathosis in the area of injection and inability to give informed consent.
Inclusion criteria: mandibular first molars with irreversible pulpitis and spontaneous pain.
Intervention groups
Injection of infiltration in retromolar pad
Main outcome variables
Numbness of mandibular first molar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161031030608N2
Registration date:2018-08-08, 1397/05/17
Registration timing:retrospective
Last update:2018-08-08, 1397/05/17
Update count:0
Registration date
2018-08-08, 1397/05/17
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
Email address
karamifar@iaushiraz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Anaesthetic efficiency of supplemental infiltration of retromolar pad after inferior alveolar nerve block in mandibular first molars with symptomatic irreversible pulpitis.
Public title
Effect of retromolar pad infiltration on mandibular first molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mandibular first molars with irreversible pulpitis
Spontaneous pain
Exclusion criteria:
younger than 18 years
allergic to local anesthetics or sulfites
pregnancy
history of significant medical conditions
taking any medications like over-the-counter painkillers, sedatives, anti-anxiety or antidepressant medications that may affect pain assessment
active sites of Pathosis in the area of injection
inability to give informed consent
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz Azad University
Street address
No. 14, South Ghaani st., Azad university of dentistry
City
shiraz
Province
Fars
Postal code
7473171987
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1397.001
Health conditions studied
1
Description of health condition studied
Symptomatic irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Numbness or lack of numbness
Timepoint
15 and 5 minutes after injection
Method of measurement
Electric pulp tester and cold test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Administer of half of cartridge volume of 2% lidocaine with 1:100000 epinephrine in the retromolar pad area
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Azad dentistry university of shiraz
Full name of responsible person
Kasra Karamifar
Street address
No. 14, South Ghaani st., Azad university of dentistry
City
Shiraz
Province
Fars
Postal code
74731-71987
Phone
+98 71 3830 8200
Email
kasra.karamifar@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahereh Baheri Moghadam
Street address
No. 14, South Ghaani st., Azad dentistry university
City
Shiraz
Province
Fars
Postal code
74731-71987
Phone
+98 71 3830 8200
Fax
+98 71 3641 0059
Email
kasra.karamifar@gmail.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
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
Kasra karamifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 14, South Ghaani st., Azad dentistry university
City
Shiraz
Province
Fars
Postal code
74731-71987
Phone
+98 71 3830 8200
Email
kasra.karamifar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
kasra karamifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 14, South Ghaani st., Azad university of dentistry
City
Shiraz
Province
Fars
Postal code
74731-71987
Phone
+98 38308200
Email
kasra.karamifar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
kasra karamifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 14, South Ghaani st., Azad university of dentistry
City
Shiraz
Province
Fars
Postal code
74731-71987
Phone
+98 38308200
Email
kasra.karamifar@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Those part of documents that are related to main subject will be released after making the participants unknown.
When the data will become available and for how long
2 years after publishing the results.
To whom data/document is available
Dentists
Under which criteria data/document could be used
To make progress in this research and the do related studies,documents will be availabe.