The purpose of this study was to compare the success rate of IAN block injection carried out with two cartridges of 2% lidocaine with 1:100000 epinephrine each combined with 0.2ml dexamethasone versus two cartridges of 2% lidocaine with 1:100000 epinephrine each combined with 0.2 ml sterile distilled water for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.
Design
Randomised, double-blinded clinical trial with a parallel group design of 100 patients randomly divided into two groups of 50 subjects each, using random number generator software.
Settings and conduct
Department of Endodontics, Dental School, Isfahan
Each random number will be kept in a separate sealed opaque envelope. This procedure is done by a third person who has no clue and has not involved in the rest of the study and only the random number is used on the data collection sheets to further blind the experiment.
Participants/Inclusion and exclusion criteria
One hundred adult patients participated in this clinical trial. All of the subjects were in good health as determined by a health history and oral questioning. Exclusion criteria were as follows: Under 18 years of age, allergy to local anesthetics or sulfites, pregnancy, lactating and the inability to give written informed consent or understand the use of pain scales. Also patients with a periapical lesion (except for a widened periodontal ligament) were not included in this study. Therefore, to qualify for the study, each patient had a vital mandibular molar tooth with a clinical diagnosis of symptomatic irreversible pulpitis.
Intervention groups
Intervention group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.2 ml dexamethasone being injected.
Control group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.2 ml sterile distilled water being injected.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091004002541N7
Registration date:2018-05-17, 1397/02/27
Registration timing:retrospective
Last update:2018-05-17, 1397/02/27
Update count:0
Registration date
2018-05-17, 1397/02/27
Registrant information
Name
Masoud Saatchi
Name of organization / entity
School of Dentistry, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2822
Email address
saatchi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-01, 1395/05/11
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
2016-08-01, 1395/05/11
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
empty
Scientific title
Anesthetic efficacy of Dexamethasone added to Lidocaine for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis
Public title
Anesthetic efficacy of Dexamethasone added to Lidocaine for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Eighteen years of age and over
Being in good health condition
Having a mandibular molar tooth with symptomatic irreversible pulpitis
Normal periapical radiographic appearance (except for a widened periodontal ligament)
Not having severe periodontal problem
No history of allergy to local anesthesia or sulfite
Exclusion criteria:
Pregnancy or lactation
Taking any medications that might cause altered pain sensation
ِAny swelling or sinus tract near the target tooth
Active sites of pathosis in the area of injection
Inability of the patient to give an informed consent
Lack of lip numbness within 15 minutes after injection
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients choose the envelope with simple random sampling protocol to determine which anesthetic solution will be administered.
Blinding (investigator's opinion)
Double blinded
Blinding description
Five-digit random numbers are being generated by using computer random numbers and they are written on a label on the anesthetic solutions. Each random number will be kept in a separate sealed opaque envelope. All these procedures is done by a third person who has no clue and has not involved in the rest of the study and only the random number is used on the data collection sheets to further blind the experiment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81744-73461
Approval date
2016-07-01, 1395/04/11
Ethics committee reference number
396731
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
Pain
Timepoint
Before treatment and after initiating root canal therapy
Method of measurement
Heft-Parker visual analog scale (VAS)
Secondary outcomes
1
Description
Post pain
Timepoint
During procedure
Method of measurement
Heft-Parker visual analog scale (VAS)
Intervention groups
1
Description
Intervention group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.2 ml dexamethasone applied by using conventional inferior alveolar nerve block injection technique.
Category
Treatment - Drugs
2
Description
Control group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.2 ml sterile distilled water applied by using conventional inferior alveolar nerve block injection technique.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Endodontics, Dental School, Isfahan
Full name of responsible person
Masoud Saatchi
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2822
Email
saatchi@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Masoud Saatchi
Street address
Vice chancellor for research, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2822
Email
saatchi@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Saatchi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2822
Fax
Email
saatchi@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Saatchi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2822
Fax
Email
saatchi@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Saatchi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2822
Fax
Email
saatchi@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available