The comparison of anesthetic efficacy of Articaine versus Lidocaine in Inferior Alveolar Nerve Block plus Intraligamentary injections in mandibular molar teeth with irreversible pulpitis
Our aim is the comparison of anesthetic efficacy of Articaine versus Lidocaine in Inferior Alveolar Nerve Block injection plus Intraligamentary injection in mandibular molars with irreversible pulpitis. 60 patients will be participated in this study in Shahid Beheshti University of Medical Sciences. All the patients should have first or second vital mandibular molar without spontanous pain and positive response to Electrical Pulp Tester and prolonged response to the cold test. Before the anesthetic injections the patients will be asked to indicate their pain, in each stage, before and after the Inferior Alveolar Nerve Block and Intraligamentary Injections and while preparing access cavity and initial filing on Heft Parker Visual Analogue Scale. The patients will be divided randomly into 2 subgroups and will be received Lidocaine or Articaine. The pulse rate will be measured in each stage by pulse-oximeter. All the patients will be received 1.8 ml Inferior Alveolar Nerve Block injection of each anesthetic solution; 2% Lidocaine with epinephrine 1/80000 or 4% Articaine with epinephrine 1/100000. If the Electrical Pulp Tester number will be under 80; we will perform supplemental injection by the same solution. The access cavity will be prepared and initial filling will be done.The patients will indicate their pain in these two stages on Heft Parker Visual Analogue Scale. The success of 2 injections is the ability for preparing the access cavity and initial filling with no or mild pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100523253N2
Registration date:2016-10-17, 1395/07/26
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-10-17, 1395/07/26
Registrant information
Name
Nazanin Zargar
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3075
Email address
n.zargar48@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of anesthetic efficacy of Articaine versus Lidocaine in Inferior Alveolar Nerve Block plus Intraligamentary injections in mandibular molar teeth with irreversible pulpitis
Public title
Comparison of Articaine and Lidocaine as an anesthetic supplemental injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients older than 18 without any systemic diseases; First or second mandibular molar with irreversible pulpitis; No pre apical lesion in radiography; Response to Electrical Pulp Tester; Prolonged response to the cold test
Exclusion criteria: Allergic response to Lidocaine or Articaine; pre apical radiolucency; Lactate or pregnant women; Using analgesic drugs since 12 hours before the treatment; Mobility more than 0.5 mm; Probing more than 3 mm in mesial and distal; Severe dental pain that needs emergency treatment; Nonvital coronal pulp tissue; Teeth with full crown; No lip numbness after the Inferior Alveolar Nerve Block injection; No pulp exposure after removing caries
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Dental School, Daneshjoo boulevard, Shahriari square, Velenjak
City
Tehran
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.63
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
B95
ICD-10 code description
Streptococcus and staphylococcus as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Anesthesia
Timepoint
After Inferior Alveolar Nerve Block injection; After supplemental injection
Method of measurement
Electrical pulp tester
2
Description
Pulse
Timepoint
Before Inferior Alveolar Nerve Block injection; After Inferior Alveolar Nerve Block injection; After supplemtal injection
Method of measurement
Pulse-oximeter
3
Description
Pain during injection
Timepoint
During Inferior Alveolar Nerve Block and supplemental injection
Method of measurement
Heft Parker Visual Analog Scale
4
Description
Pain
Timepoint
After Inferior Alveolar Nerve Block and supplemental injection
Method of measurement
Heft Parker Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
After Inferior Alveolar Nerve Block injection with Lidocaine with Epinephrine 1/80000, supplemental Intraligamentry injection with the same anesthetic material will be done.
Category
Treatment - Drugs
2
Description
After Inferior Alveolar Nerve Block injection with Articaine with Epinephrine 1/100000, supplemental Intraligamentry injection with the same anesthetic material will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical University
Full name of responsible person
Dr.Nazanin Zargar(The assistant professor of Shahid Beheshti Dental School)
Street address
Dental school of Shahid Beheshti University of Medical Sciences , Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University Of Dental School
Full name of responsible person
Dr. Zarghi
Street address
Dental school of Shahid Beheshti University of Medical Sciences , Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University Of Dental 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
Assistant professor
Full name of responsible person
Nazanin Zargar
Position
Shahid Beheshti University of Medical Sciences
Other areas of specialty/work
Street address
Dental school of Shahid Beheshti University of Medical Sciences , Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2217 5350
Fax
Email
nzargar48@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Zargar
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid beheshti University of Dental School, Daneshjoo boulevard, Shahriari square, Velenjak
City
Tehran
Postal code
Phone
+98 21 2217 5350
Fax
Email
nzargar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Zargar
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid beheshti University of Dental School, Daneshjoo boulevard, Shahriari square, Velenjak
City
Tehran
Postal code
1985717443
Phone
+98 21 2217 5350
Fax
Email
Nzargar48@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)