Protocol summary

Study aim
Comparison of the effect of lidocaine, articaine and mepivacaine on pulpal anesthesia in maxillary molars with irreversible pulpitis Determining the percentage of anesthesia in the group receiving lidocaine, articaine and mepivacaine Comparison of anesthesia in groups receiving lidocaine, articaine and mepivacaine based on gender and age Determining the mean time of onset of anesthesia in lidocaine, articaine and mepivacaine groups Comparison of mean onset time of anesthesia of lidocaine, articaine and mepivacaine groups Comparison of cold response percentage in three groups of lidocaine, articaine and mepivacaine
Design
Double-blind clinical trial with 114 samples with three parallel and randomized groups with six permutation blocks
Settings and conduct
Due to the importance of creating deep anesthesia in dental treatments, this study will be performed in Guilan Dental School. In this study, 114 maxillary first or second molars in people with irreversible pulpitis were divided into three groups of 38 and each group was injected with one of three types of anesthesia: mepivacaine, lidocaine and articaine. After injection using an electronic pulp tester And the cold test is checked every two minutes for up to 10 minutes. The teeth that were anesthetized will be treated. If the painless treatment is successful, it will be classified as a success in creating anesthesia.
Participants/Inclusion and exclusion criteria
Patients over 16 years of age and under 65 years of age who have not had any systemic disease or have taken any medication, have not smoked without a history of allergy to anesthesia, have not taken painkillers within 24 hours, are not pregnant or breastfeeding.
Intervention groups
Lidocaine group Mepivacaine group Articaine Group
Main outcome variables
anesthesia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220226054132N1
Registration date: 2022-03-06, 1400/12/15
Registration timing: prospective

Last update: 2022-03-06, 1400/12/15
Update count: 0
Registration date
2022-03-06, 1400/12/15
Registrant information
Name
Farhad Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3340 2051
Email address
farhadja.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-02, 1401/01/13
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the effect of lidocaine, articaine and mepivacaine on pulpal anesthesia in maxillary molars with irreversible pulpitis (double-blind randomized trial)
Public title
A Comparison of the effect of lidocaine, articaine and mepivacaine on pulpal anesthesia in maxillary molars with irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
people must have irreversible pulpitis in maxillary molar
Exclusion criteria:
Age
From 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the block randomization method with 4 permutation blocks will be used. For this reason, considering that the study is double-blind and only analysts are aware of the study groups, considering the blind therapies A, B and C, the order of assigning treatment to individuals based on the time of their study will be as follows: (The complete randomization file is available as an Excel file. The randomization was done with SAS software version 9): Seed: 117257145755086 Block sizes: 6 Actual list length: 114 block identifier, block size, sequence within block, treatment • 1, 6, 1, Group C • 1, 6, 2, Group B • 1, 6, 3, Group C • 1, 6, 4, Group A • 1, 6, 5, Group A • 1, 6, 6, Group B • 2, 6, 1, Group B • 2, 6, 2, Group C
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients are divided into three experimental groups by block randomized randomization. Patients are classified into four subgroups based on sex and tooth type (maxillary first or second molars). Patients in each subgroup are then randomly assigned to lidocaine, articaine, and mepivacaine groups using six blocks. Equal number of lidocaine and articaine and mepi-cocaine cartridges are prepared and given a code. To hide random allocation, a code-aware nurse randomly provides cartridges to clinicians based on groups (lidocaine, articaine, and mepivacaine). There is a code for each packed cartridge. One clinician fills out a questionnaire. And another clinician does the injections. All injections are performed by a clinician. This is a double-blind study, meaning that the clinician performing the injections, the patient, the person evaluating the outcome, and the statistician are not aware of the type of anesthetic
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
No. 31, Professor Samiei Blvd., Fooman Shimi Complex
City
Rasht
Province
Guilan
Postal code
4484154179
Approval date
2022-02-24, 1400/12/05
Ethics committee reference number
IR.GUMS.REC.1400.591

Health conditions studied

1

Description of health condition studied
Irreversible pulpitis
ICD-10 code
B95
ICD-10 code description
Streptococcus, Staphylococcus, and Enterococcus as the cause of diseases classified elsewhere

Primary outcomes

1

Description
Answer to electronic pulp tester and cold test
Timepoint
2, 4, 6, 8 and 10 minutes
Method of measurement
Using the electronic pulp tester and increasing its degree from 0 to 8, if the tooth does not feel numb, and using a cotton ball on which the cold spray is sprayed and the buccal side of the tooth is studied for up to 10 seconds.

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: lidocaine receiving group - the second intervention group: articaine receiving group - the third intervention group: mipivacaine receiving group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan Faculty of Dentistry
Full name of responsible person
Farhad Jamali Afarmejani
Street address
No. 31, Professor Samiei Blvd., Fooman Shimi Complex
City
Rasht
Province
Guilan
Postal code
4484154179
Phone
+98 933 539 9584
Email
farhadja.a@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Guilan Faculty of Dentistry
Street address
Rasht Saravan Belt to Fooman University Complex of Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6406
Email
dental@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
50
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
Rasht University of Medical Sciences
Full name of responsible person
Farhad Jamali
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No31.Fomanshimi Complex Professor samei Blvd. Rasht
City
Rasht
Province
Guilan
Postal code
4484154179
Phone
+98 13 3340 2051
Fax
Email
farhadja.a@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Farhad Jamali
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No31.Fomanshimi Complex Professor samei Blvd. Rasht
City
Rasht
Province
Guilan
Postal code
4484154179
Phone
+98 13 3340 2051
Fax
Email
farhadja.a@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Farhad Jamali
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No31.Fomanshimi Complex Professor samei Blvd. Rasht
City
Rasht
Province
Guilan
Postal code
4484154179
Phone
+98 13 3340 2051
Fax
Email
farhadja.a@gmail.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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