The purpose of this clinical trial study is to compare the anesthetic efficacy of a buffered with a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block in patients with mandibular posterior teeth experiencing symptomatic irreversible pulpitis. Eighty adult patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth will be selected.All were emergency patients of dental clinic of Isfahan University of Medical Sciences.The patientswill be received two cartridges of either 1.5 mL of 2% lidocaine with 1:80,000 epinephrine buffered with 0.3 mL of 8.4% sodium bicarbonate or 1.5 mL of 2% lidocaine with 1:80,000 epinephrine with 0.3 mL of sterile distilled water using conventional IAN block injections. Endodontic access preparation will be begun 15 minutes after injection. Lip numbness is required for all patients. If the patient felt pain during access cavity preparation or initial file placement, the treatment was immediately ceased and the patient rated the discomfort by using Heft-Parker visual analog scale. Success will be determined as no or mild pain on the basis of Heft-Parker visual analog scale recordings upon endodontic access or initial instrumentation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090219021N1
Registration date:2014-09-13, 1393/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-13, 1393/06/22
Registrant information
Name
Badri Baghaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2886
Email address
f-rajati@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Iisfahan University of Medical Science
Expected recruitment start date
2014-09-13, 1393/06/22
Expected recruitment end date
2014-12-13, 1393/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Sodium Bicarbonate Buffered Lidocaine 2% on the Success of Inferior Alveolar Nerve Block for Teeth with Symptomatic Irreversible Pulpitis
Public title
Effect of Sodium Bicarbonate Buffered Lidocaine 2% in the treatment of teeth with acute pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 20-60 years; no history of systemic diseases; lower molars with symptomatic irreversible pulpitis
exclusion criteria: active sites of pathosis in the area of injection; Lack of lip numbness within 15 minutes after injection
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Isfahan Regional Bioethics Committee
Street address
University of Medical Sciences
City
Isfahan
Postal code
8174673461
Approval date
2014-08-09, 1393/05/18
Ethics committee reference number
193396
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
degree of initial pain
Timepoint
before root canal therapy
Method of measurement
visual analogous scale
Secondary outcomes
1
Description
degree of Secondary pain
Timepoint
during root canal therapy
Method of measurement
visual analogous scale
Intervention groups
1
Description
patients will divided into two groups. 2 inferior alveolar nerve block with 2 similar cartridges will be injectet to each patient. . Endodontic access preparation will be begun 15 minutes after injection. Lip numbness is required for all patients.the patients in the control group will be received two cartridges of 1.5 mL of 2% lidocaine (Lignospan; Septodont, Saint Maur des Fosses, France) with 1:80,000 epinephrine with 0.3 mL sterile distilled water
Category
Treatment - Drugs
2
Description
patients will divided into two groups. 2 inferior alveolar nerve block with 2 similar cartridges will be injectet to each patient. . Endodontic access preparation will be begun 15 minutes after injection. Lip numbness is required for all patients.the patients in the first experimental group will be received two cartridges of 1.5 mL of 2% lidocaine with 1:80,000 epinephrine(Lignospan; Septodont, Saint Maur des Fosses, France) buffered with 0.3 mL of 8.4% sodium bicarbonate (8.4% weight/volume, 50 mEq/50 mL, Samen Laboratories, Iran).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Science
Full name of responsible person
Dr.Badri Baghaei
Street address
Hezarjarib St., Dental clinic, Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Omid Savabi
Street address
Department of Research and Technology, Building No. 4, Central Organ of University, Isfahan university of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Badri Baghaei
Position
Post graduate student of Endodontics
Other areas of specialty/work
Street address
Heza Jarib St, Faculty of dentistry, Isfahan university of Medical Scieces
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2886
Fax
+98 31 3669 2585
Email
f-rajati@hlth.mui.ac.irbadribaghaie@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Masoud Saatchi
Position
Endodontics, Associate Prof.
Other areas of specialty/work
Street address
Faculty of Dentistry, Isfahan university of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 317922886
Fax
+98 31 3669 2585
Email
saatchi@dnt.mui.ac.irbadribaghaie@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Badri Baghaei
Position
Post graduate student of Endodontics
Other areas of specialty/work
Street address
Faculty of dentistry, Isfahan university of Medical Scieces, Heza Jarib St.
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2886
Fax
+98 31 3669 2585
Email
f-rajati@hlth.mui.ac.irbadribaghaie@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)