Comparative evaluation of anesthetic efficacy of 1.8 and 3.6 milliliter buccal infiltrations, and buccal plus palatal infiltrations with articaine in maxillary first molars with irreversible pulpitis
Goal : To choose the best anesthetic administration technique for first maxillary molar diagnosed with irreversible pulpitis
Study design : Randomized , single blind clinical trial
Inclusion Criteria :Patients with first maxillary molar diagnosed with Symptomatic Irreversible Pulpitis
Exclusion Criteria : patients that have used sedatives in the last 12 hours,pregnancy,allergies
sample size :45
study intervention : Group 1:1.8 milliliters buccal infiltration Group 2 : 3.6 milliliters buccal infiltration , Group 3 : 1.8 milliliters buccal infiltration plus 0.5 milliliters palatal infiltration
Intervention time : before access cavity preparation
Outcomes Studied : level of pain on a visual analogue scale
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011020238N2
Registration date:2015-03-04, 1393/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-04, 1393/12/13
Registrant information
Name
Farzaneh Afkhami Jeddi
Name of organization / entity
Tehran University of Medical Sciences International Campus
Country
Iran (Islamic Republic of)
Phone
+98 21 5585 1131
Email address
f-afkhami@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences International Campus Dental School
Expected recruitment start date
2014-01-15, 1392/10/25
Expected recruitment end date
2015-03-15, 1393/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of anesthetic efficacy of 1.8 and 3.6 milliliter buccal infiltrations, and buccal plus palatal infiltrations with articaine in maxillary first molars with irreversible pulpitis
Public title
Comparison of anesthetic efficacy of articaine in different anesthetic administration methods and volumes in maxillary first molars
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: Patients with systemic diseases , Patients that have used any form of sedatives in the past 12 hours , Patients that have allergies to anesthetics or sulfites, pregnancy , Patients that are unable give informed consent , Patients with periapical lesions.
Inclusion criteria :Patients between the ages of 18 to 60 , Patients with first maxillary molars diagnosed with Symptomatic Irreversible Pulpitis
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Tehran University of Medical Sciences International Campus Dental School
Street address
Zolfi St. - Khani Abad no
City
Tehran
Postal code
Approval date
2013-07-14, 1392/04/23
Ethics committee reference number
21092
Health conditions studied
1
Description of health condition studied
Irreversible Pulpitis
ICD-10 code
k04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain
Timepoint
after 20 minutes
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
group 1: Maxillary first molar buccal infiltration with 4% Articaine with 1:100000 Epinephrine 1.8 ml
Category
Treatment - Other
2
Description
group 2 :Maxillary first molar buccal infiltration with 4% Articane with 1:100000 Epinephrine 3.6 ml
Category
Treatment - Other
3
Description
group 3:Maxillary first molar buccal infiltration with 4% Articaine with 1:100000 Epinephrine 1.8 ml plus palatal infiltration with 4% Articaine with 1:100000
Epinephrine 0.5 ml
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences International Campus Dental School
Full name of responsible person
Reza Yazdani
Street address
Zolfi St. -Khani Abad no - Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences International Campus Dentistry School
Full name of responsible person
Reza Yazdani
Street address
Zolfi St. -Khani Abad no - Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences International Campus Dentistry School
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
Tehran University of Medical Sciences International Campus Dentistry School
Full name of responsible person
Fardad Kamalian
Position
Professional Doctorate Student
Other areas of specialty/work
Street address
Zolfi St. - Khani Abad no
City
Tehran
Postal code
Phone
+98 21 5585 1149
Fax
Email
fardad.kamalian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences International Campus Dentistry School
Full name of responsible person
Farzane Afkhami Jeddi
Position
Endodontist , Assistant Professor
Other areas of specialty/work
Street address
Zolfi St. - Khani Abad no
City
Tehran
Postal code
Phone
+98 21 5585 1149
Fax
Email
f-afkhami@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences International Campus Dentistry School
Full name of responsible person
Fardad Kamalian
Position
Professional Doctorate Student
Other areas of specialty/work
Street address
Zolfi St. - Khani Abad no
City
Tehran
Postal code
Phone
00
Fax
Email
fardad.kamalian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)