The purpose of this study is to compare the success rate of inferior alveolar nerve block (IANB) injection carried out with two cartridges of 2% lidocaine with 1:100000 epinephrine each combined with 0.25 ml fentanyl versus two cartridges of 2% lidocaine with 1:100000 epinephrine each combined with 0.25 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 will participate in this clinical trial. All of the subjects must be 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 and the inability to give written informed consent or understand the use of pain scales. Also patients with a periapical lesion will not include in this study. Therefore, to qualify for the study, each patient must have 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 0.25 ml Fentanyl being injected. Control group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.25 ml sterile distilled water being injected.
Main outcome variables
Pain
General information
Reason for update
Acronym
مطالعه بی حسی دندان و فنتانیل اصفهان
IRCT registration information
IRCT registration number:IRCT20191114045442N1
Registration date:2020-02-27, 1398/12/08
Registration timing:registered_while_recruiting
Last update:2020-02-27, 1398/12/08
Update count:0
Registration date
2020-02-27, 1398/12/08
Registrant information
Name
Neda Shekarchizade esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 5052
Email address
neda_shekarchizade@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fentanyl on the success of inferior alveolar nerve block for teeth with symptomatic irreversible pulpitis
Public title
Effect of fentanyl on the success of anesthesia for painful teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years of age up to 60
in good health(ASA I (classification of the American Society of Anesthesiologists))
having at least one mandibular molar tooth with 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:
Taking any medications that might cause altered pain sensation
Any swelling or sinus tract near the target tooth
pregnant or nursing mothers
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
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is based on block randomization using four blocks.
25 blocks of four quadrants will be selected randomly adopting random number table method. Patients under study will be assigned to one of two groups of intervention and control groups based on the order of blocks selection.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs used in similar cartridges are prepared. The mentioned drugs will be differentiated from each other based on a four-digit code that is pasted on them with the usage of a random number table method. There is no difference in terms of shape, size and other physical characteristics.Therefore, the patient and the individual assessing the impact of the intervention will not be able to detect the drug in the intervention and control groups.
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
2019-10-08, 1398/07/16
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.430
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
empty
Intervention groups
1
Description
Intervention group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.25 ml fentanyl 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 0.25 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
Neda Shekarchizade
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5047
Email
neda_shekarchizade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Shekarchizade
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
Neda_shekarchizade@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Neda Shekarchizade
Position
Assistant 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
Email
Neda_shekarchizade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Shekarchizade
Position
Assistant 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
Email
Neda_shekarchizade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Shekarchizade
Position
Assistant 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
Email
Neda_shekarchizade@yahoo.com
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