The purpose of this study was to compare the effect of Bupivacaine and Lidocaine as local anesthetics on the incidence of flare-up after root canal therapy. A total of 60 patients who presented to the office of 3 endodontists were invited to participate in this double blind study. Patients had no history of cardiovascular disease, hypersensitivity to amide types of local anesthetics, renal failure, or hyperthyroidism. The patients were randomly assigned into one of two groups: 0.5 percent Bupivacaine 1/200000 Epinephrine or 2 percent Lidocaine 1/100000 Epinephrine. After root canal therapy, the extent of postoperative pain was measured in 48 hours and categorized in 4 scores, 0 to 3.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809082785N1
Registration date:2010-05-29, 1389/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Safoora Sahebi
Name of organization / entity
Shiraz University of Medical Sciences, Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 3193
Email address
sahebis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
without
Expected recruitment start date
2009-08-01, 1388/05/10
Expected recruitment end date
2009-12-29, 1388/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effect of Bupivacaine and Lidocaine as Local Anesthetics on Incidence of Flare-up after Root Canal Therapy
Public title
Comparison of Effect of Bupivacaine and Lidocaine as Local Anesthetics on Incidence of Flare-up after Root Canal Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients without heart disease, allergic to amid group anesthesia, renal failure, hyperthyroidism,
Exclusion criteria: patient’s noncooperation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Dental School, Ghomabad St.
City
Shiraz
Postal code
7195615878
Approval date
empty
Ethics committee reference number
230/1/88
Health conditions studied
1
Description of health condition studied
Post operative pain after endodontic treatment
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
pain after endodontic treatment
Timepoint
12, 24, 48 hours after the procedure
Method of measurement
visiual analoge scale
Secondary outcomes
empty
Intervention groups
1
Description
bupivacaine 0.5% with 1/200000 epinephrine, one dose, 1.8 ml for block or infiltration annesthesia
Category
Treatment - Drugs
2
Description
Lidocaine 2%, one dose, with epinephrine 1/100000, for block or infiltration anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic of Shiraz Dental School
Full name of responsible person
Dr. Safoora Sahebi
Street address
Ghomabad street, Shiraz Dental School
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Safrooa Sahebi
Street address
Shiraz Dental School,
City
Shiraz,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Safoora Sahebi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shiraz Dental School
City
Shiraz
Postal code
71956/15878
Phone
+98 71 1626 3193
Fax
+98 71 1635 4861
Email
sahebis@sums.ac.ir
Web page address
http://dental.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medial Sciences
Full name of responsible person
Dr. Safoora Sahebi
Position
Assistant Professor of Endodontic Department
Other areas of specialty/work
Street address
Shiraz Dental School
City
Shiraz
Postal code
71956/15878
Phone
+98 71 1626 3193
Fax
+98 71 1635 4861
Email
Sahebis@sums.ac.ir
Web page address
http:/dental.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr. Safoora Sahebi
Position
Assistant Professor of Endodontic Department
Other areas of specialty/work
Street address
Shiraz Dental School,
City
Shiraz
Postal code
71956/15878
Phone
+98 71 1626 3193
Fax
+98 71 1635 4861
Email
sahebis@sums.ac.ir
Web page address
http://dental.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)