Evaluating the Effect of Adding Magnesium Sulfate to Lidocaine/Epinephrine on the Success Rate of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis
The aim of this study is evaluation of the effect of adding Magnesium Sulphate to lidocaine/epinephrine on success rate of Inferior Alveolar Nerve Block in patient with Symptomatic Irreversible Pulpitis. Among the patients who are referred to Endodontics Department of Tehran Islamic Azad University from January to March 2017, 54 patients who have Irreversible pulpitis in lower molars are randomly allocated into two groups. Inclusion criteria: Patients with symptomatic irreversible pulpitis referred to endodontics Islamic Azad University in Tehran; willingness to participate in the study. Exclusion criteria: any systemic diseases, pregnancy and lactation, narcotic usage. Randomization will be performed using sealed envelopes among the patients who will agree to participate in the study and voluntarily sign consent form. To randomize the patients, a number wiil be allocated to each patient. The numbers are written on a piece of paper and then one will be kept in a separate sealed opaque envelope. Each patient will be asked to choose one of the envelopes and accordingly will be assigned to one of the two groups. To make the study double-blind, operators will be kept unaware about the type of anesthetic solution. Patients receive either 0.6ml Magnesium Sulfate 50% with 1.2ml Lidocaine2%/epinephrine1:100,000 or 0.6ml Normal saline with 1.2ml lidocaine 2%/ epinephrine1:100,000 in one cartridge as the anesthetic solutions for IANB. When Lip numbness is reported by the patients and after 3 times negative answer to Electric pulp test, Endodontic access preparation will be initiate within 9 minutes. Pain is the main outcome of interest. Success of IAN block is defined as no or mild pain rated on the visual analogue scale during access cavity preparation and initial instrumentation. Patients will be asked to report any pain and in the case of pain incidence, treatment will be stopped and pain rate will be assessed using VAS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110723620N3
Registration date:2017-02-11, 1395/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-11, 1395/11/23
Registrant information
Name
Mohammadreza Moshari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
rmoshari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-02-08, 1395/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Adding Magnesium Sulfate to Lidocaine/Epinephrine on the Success Rate of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis
Public title
Effect of Magnesium Sulfate on the Success rate of Inferior Alveolar Nerve Block
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with symptomatic irreversible pulpitis referred to endodontics Islamic Azad University in Tehran; willingness to participate in the study. Exclusion criteria: any systemic diseases, pregnancy and lactation, narcotic using; cigarette smoking, analgesic drug usage during 24 hours before treatment, allergy to anesthetic drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Ethics committee of Dentistry branch, Tehran Islamic Azad University
Street address
No4, 10th Neyestan, Pasdaran Ave
City
Tehran
Postal code
19585/175
Approval date
2016-12-20, 1395/09/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,16
Health conditions studied
1
Description of health condition studied
Irreversible Pulpitis
ICD-10 code
k04.0
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
Pain
Timepoint
During Access Cavity creation, During Exposure,Initial initial instrumentation
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Unset of anesthesia
Timepoint
3-6-9 minute after Intervention
Method of measurement
Electric pulp tester
Intervention groups
1
Description
Intervention group: 1.2 ml lidocain2% in combination with epinephrine 1/100000 (produced by DarouPakhsh Company) in addition to 0.6 ml Magnesium Sulphate 50%( produced by Pasteur Institute) will be prescribed in single dosage.
Category
Treatment - Drugs
2
Description
Control group: 1.2 ml Lidocaine2% in combination with Epinephrine1/100000 (produced by DarouPakhsh Company) in addition to 0.6 ml Normal Salin will be prescribed in single dosage.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
endodontics department, Dentistry branch, Tehran Islamic Azad University
Full name of responsible person
Dr Amirabbas Moshari
Street address
No4, 10th Neyestan, Pasdaran Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of research of Dental branch, Tehran Islamic Azad University
Full name of responsible person
DR. Arash Azizi
Street address
No4, 10th neyestan , pasdaran Ave
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of research of Dental branch, Tehran Islamic Azad University
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
Department of Endodontics, School of Dentistry, Islamic Azad University
Full name of responsible person
Dr Amirabbas Moshari
Position
Assistance profesor
Other areas of specialty/work
Street address
No.4, Neyestan 10th, Pasdaran Ave
City
TEHRAN
Postal code
19585/175
Phone
+98 21 2281 8161
Fax
Email
amirabbas.moshari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesia department, Shahid beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Moshari
Position
Assisstant professor
Other areas of specialty/work
Street address
Taleghani Educational Hospital, Shahid Aarabi Ave, Yaman St, Chamran High Way
City
Teharn
Postal code
1985711151
Phone
+98 21 2243 2595
Fax
Email
Rmoshari@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Dentistry
Full name of responsible person
Sepideh darabi
Position
Dental Student
Other areas of specialty/work
Street address
No4, 10th Neyestan, Pasdaran Ave
City
Tehran
Postal code
19585/175
Phone
+98 22564571
Fax
Email
sepideh_darabi92@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)