The purpose of this clinical trial was comparative evaluation of hemodynamic effects of various local anesthetics after injection for endodontic treatment. The patients must need endodontic treatment for premolar or molar teeth at same side of injection. They shouldn’t have had any systemic condition, history of any drug in last week, pregnancy and anxiety. 80 healthy participants between 18 and 50 years of age were selected. Interventions were Lidocaine 2% + Epinephrine 1/: 80000, Prilocaine3% +0.03 IU/ml felypressin, Articaine 4% + Epinephrine 1/: 100000 and Mepivacaine 3%. The hemodynamic parameters including systolic and diastolic blood pressure (BP) and heart rate (HR) were recorded at 7 stages using an electrocardiogram. Stage 1: upon entrance into the office, stage 2: 15 minutes after the patient was seated, stage 3: immediately before the injection, stages 4-7: immediately, 5, 10 and 15 minutes after the injection. Changes of systolic and diastolic BP, heart rate and arrhythmia were studied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011316210N1
Registration date:2014-04-13, 1393/01/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-13, 1393/01/24
Registrant information
Name
Farahnaz Dadgar
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1242 7820
Email address
dr.dadgar@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Hemodynamic Properties of Different Anesthetic Agents in Endodontic Therapy
Public title
evaluation of cardiovascular properties of Different Anesthetic Agents in root canal Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having heaith and at least one mandibular molar or premolar painful tooth; requiring endodontic therapy on the side of injection.
Exclusion criteria: patients reporting history of any systemic condition; history of any drug in last wee; pregnancy and anxiety.
Age
From 17 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical of Sciences
Street address
Hesabi Sq, Zahedan,Iran
City
Zahedan
Postal code
98167434630
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
2871
Health conditions studied
1
Description of health condition studied
Endodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
heart rate
Timepoint
Stage 1: Upon entrance into the office, Stage 2: 15 minutes after the patient was seated, Stage 3: immediately before the injection, Stages 4-7: immediately, 5, 10 and 15 minutes after the injection
Method of measurement
a monitoring device (1800, Saadat)
2
Description
arythmia
Timepoint
Stage 1: Upon entrance into the office, Stage 2: 15 minutes after the patient was seated, Stage 3: immediately before the injection, Stages 4-7: immediately, 5, 10 and 15 minutes after the injection
Method of measurement
a monitoring device (1800, Saadat)
3
Description
systolic blood pressure
Timepoint
Stage 1: Upon entrance into the office, Stage 2: 15 minutes after the patient was seated, Stage 3: immediately before the injection, Stages 4-7: immediately, 5, 10 and 15 minutes after the injection
Method of measurement
a monitoring device (1800, Saadat)
4
Description
diastolic blood pressure
Timepoint
Stage 1: Upon entrance into the office, Stage 2: 15 minutes after the patient was seated, Stage 3: immediately before the injection, Stages 4-7: immediately, 5, 10 and 15 minutes after the injection
Method of measurement
a monitoring device (1800, Saadat)
Secondary outcomes
empty
Intervention groups
1
Description
inferior alveolar nerve block using one cartridge of Lidocaine 2% + Epinephrine 1: 80000 in 7 stages
Category
Treatment - Drugs
2
Description
inferior alveolar nerve block using one cartridge of Prilocaine3% +0.03 IU/ml felypressin in 7 stages
Category
Treatment - Drugs
3
Description
inferior alveolar nerve block using one cartridge of
Articaine 4% + Epinephrine 1: 100000in 7 stages
Category
Treatment - Drugs
4
Description
inferior alveolar nerve block using one cartridge of
Mepivacaine 3% in 7 stages
Category
Treatment - Drugs
5
Description
The participants in each group by measurments before internention are themselves control.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Dentistry Facualty
Full name of responsible person
Farahnaz Dadgar
Street address
Mehr Street, Zahedan, Iran
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Hesabi Sq, Zahedan,Iran
City
Zahedan
Grant name
125401
Grant code / Reference number
125401
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Farahnaz Dadgar
Position
Endodontic Resident
Other areas of specialty/work
Street address
Zahedan Dentistry Facualty
City
Zahedan
Postal code
9817699693
Phone
+98 54 1241 2005
Fax
+98 54 1241 2003
Email
dr.dadgar@zaums.ac.ir; frhnzddgr@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Dadgar
Position
endodontist
Other areas of specialty/work
Street address
Zahedan Dentistry Faculty
City
zahedan
Postal code
9817699693
Phone
+98 54 1241 2005
Fax
+98 54 1241 2003
Email
dr.dadgar@zaums.ac.ir; frhnzddgr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Dadgar
Position
endodontist
Other areas of specialty/work
Street address
Zahedan Dentistry Facualty
City
Zzahedan
Postal code
9817699693
Phone
+98 54 1241 2005
Fax
+98 54 1241 2003
Email
dr.dadgar@zaums.ac.ir; frhmzddg@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)