Comparision of success rate of inferior alveolar nerve block protocol in mandibular first molars with symptomatic irriversible pulpitis by Prilocain and Mepivacain local anaesthesia: A randomized control clinical trial
Comparing the efficacy of Prilocaine versus Mepivacaine in inferior alveolar nerve block among the patients with irreversible pulpitis of the first molar teeth
Design
Randomized, superiority, parallel-group, double-blinded trial with blinded outcome assessment. Randomization was carried out by Randlist software.
Settings and conduct
This study was carried out in the endodontics ward of Tabriz University of Medical Science, faculty of dentistry.
Patients were stratified into two groups after obtaining informed consent. standard alveolar nerve block then performed using 2 cartridges of Mepivacaine in one group and 2 cartridges of Prilocaine_Felypressin in the other group. fifteen minutes following the injection patients were evaluated for thermal and electrical pulp sensibility tests. In case of the accurate aesthetic state, root canal treatment was started, and the patient was asked to discuss any discomfort using VAS.
both patients and researchers (including the operator, evaluator, and analyzer) were unaware of grouping during this study.
Participants/Inclusion and exclusion criteria
Patients between 18 and 65 years with symptomatic irreversible pulpitis in the first molar were enrolled in this research regarding the inclusion and exclusion criteria of the study.
Intervention groups
1. Mepivacaine group: inferior alveolar nerve block was performed using mepivacaine in this group
2. Prilocaine group: inferior alveolar nerve block was performed using prilocaine in this group
Main outcome variables
level of anesthesia in inferior alveolar nerve block
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200607047680N1
Registration date:2020-06-18, 1399/03/29
Registration timing:retrospective
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Parisa Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 8095
Email address
pariisa.rostami9013@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
2020-01-21, 1398/11/01
Actual recruitment end date
2020-05-04, 1399/02/15
Trial completion date
2020-05-04, 1399/02/15
Scientific title
Comparision of success rate of inferior alveolar nerve block protocol in mandibular first molars with symptomatic irriversible pulpitis by Prilocain and Mepivacain local anaesthesia: A randomized control clinical trial
Public title
anesthetic effect of Perilocain versus Mepivacain in inferior alveolar nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 and 65 years
Indication of Root Canal Treatment (RCT) on firs molar tooth
Normal periapical appearance
Patient's consent to participate in the study
Evidence of symptomatic irreversible pulpitis that shows a predominant pain in response to cold pulp sensibility test compared to the control teeth
Exclusion criteria:
History of allergy to anesthetic agents (of any kind)
Use of painkillers within 6 hours prior to the procedure
Use of any kind of medication with possible interaction with anesthetic agents
Presence of any pathological lesions at the site of injection
Previous history of facial trauma
Presence of pathological pocket while probing
Patients without response to cold pulp sensibility test
Presence of periradicular pathology severe than PDL widening
Patients with partial necrosis
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study randomization performed by Datinf Randlist software using a simple random sampling method
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blinded study, both patients and researchers were unaware of group stratification. Patients were kept blind about the fact that in which group they enrolled. Also, all used anesthetic agents were unlabeled and coded by a third party before use.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Tabriz University of Medical Science
Street address
Ethics committee office,Tabriz University of Medical Science, Golgasht Ave., Azadi Blv.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.TBZMED.REC.1398.1159
Health conditions studied
1
Description of health condition studied
Inferior alveolar nerve block
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of analgesia based on Visual Analog Scale
Timepoint
15 minutes after injection
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Inferior alveolar nerve block performed by single-shot injection of 2 cartridges of 3% mepivacaine (manufactured by Inibsa Dental s.t.u co) using a standard syringe with 27G, 3.6 cm needle.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: Inferior alveolar nerve block performed by single-shot injection of 2 cartridges of 3% prilocaine_felypressin 0/03IU (manufactured by DarouPakhsh Pharmaceutical MFG co) using a standard syringe with 27G, 3.6 cm needle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry of Tabriz University of Medical Science
Full name of responsible person
Mahsa Eskandarinezhad
Street address
faculty of dentistry, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
dent.fac@tbzmed.ac.ir
Web page address
https://dentistryfac.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mozhgan Kachuii
Street address
Faculty of Dentistry, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0310
Email
dent.fac@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahsa Eskandarinezhad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Endodontics department, faculty of dentistry, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Eskandarinezhadmahsa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahsa Eskandarinezhad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Endodontics department, faculty of dentistry, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Eskandarinezhadmahsa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Rostami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of endodontics, faculty of dentistry, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
Email
pariisa.rostami9013@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual participant data that underlie the reported results after proper deidentification
When the data will become available and for how long
following publication under the policy of the publisher
To whom data/document is available
Researchers who provide a methodologically sound proposal
Under which criteria data/document could be used
to achieve aims in the approved proposal
From where data/document is obtainable
Requests should be proposed to Dr. M. Eskandarinezhad via sending an email to eskandarinezhadmahsa@yahoo.com.
What processes are involved for a request to access data/document
proposals should be directed to "eskandarinezhadmahsa@yahoo.com". To gain access data requestors will need to sign a data access agreement.