Protocol summary

Study aim
Determining the success rate of infiltration anesthesia injection of 1.8 milliliter Articaine and 3.6 milliliter Articaine in mandibular canins teeth with irreversible pulpitis
Design
A clinical trial Consists of two intervention groups, with parallel groups, double-blind, randomized, on 84 patients, sealed envelopes will be used for randomization.
Settings and conduct
The study will be performed by 2 dentists in a private clinic in Rafsanjan. Before each injection, another dentist will randomly take out a piece of paper from the sealed envelope and according to the number, he will inject one of the two anesthetic volumes, so that in the first group, 1.8 milliliter of 4% Articaine solution (one anesthetic cartridge and three minutes later, the needle will be inserted into the anesthetic area without injection) and the second group, 3.6 milliliter of 4% Articaine solution (two anesthetic cartridges three minutes apart) so that the operator and the patient are not aware of the anesthesia volume. Patients are instructed to report any pain at any stage of Root canal treatment in Heft-Parker Visual Analog Scale form.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Healthy adult patients 18–60 years old having mandibular canins tooth with symptomatic irreversible pulpitis. exclusion criteria:Spontaneous pain and patients who need emergency treatment.
Intervention groups
In the 1st group, 1.8 milliliter of Articaine solution and in the second group, 3.6 milliliter of Articaine solution. 6 minutes after the anesthesia injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded the study, If the answer is positive, the tooth will be isolate by a rubberdam, the caries will be removed, the access cavity is prepared and instrumentation will be performed.
Main outcome variables
Pain rate by Visual Analogue Scale form

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091213002847N5
Registration date: 2023-08-04, 1402/05/13
Registration timing: retrospective

Last update: 2023-08-04, 1402/05/13
Update count: 0
Registration date
2023-08-04, 1402/05/13
Registrant information
Name
Mohammad Mahdi Yaghooti Khorasani
Name of organization / entity
Dental School, Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3262 7327
Email address
dr.yaghooti@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-05, 1402/01/16
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
2023-04-05, 1402/01/16
Actual recruitment end date
2023-06-15, 1402/03/25
Trial completion date
2023-06-15, 1402/03/25
Scientific title
Comparative evaluation of anesthetic efficacy of 1.8 milliliter Articaine and 3.6 milliliter of Articaine for infilteration anesthesia in mandibular canins with irreversible pulpitis: A randomized clinical
Public title
infiltration anesthetic efficacy of Articaine for mandibular canins
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients who have no systemic disease limiting dental treatment in their history Age range from 18 to 60 years has a mandibular canine with irreversible pulpitis and a normal periapical radiograph that not require emergency treatment. The patient has informed consent to participate in the study
Exclusion criteria:
History of sensitivity to 4%articaine or epinephrine Systemic diseases Pregnancy or breastfeeding Any type of medication that could potentially interact with the anesthetic solution Spontaneous pain Periodontal disease or unable to get restoration Having analgesic late 12 hours
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 90
Actual sample size reached: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomizzation individually with using a sealed envelope The even and odd numbers from 1 to 84 (even numbers for injection of 2 cartridge articaine 4% and odd numbers for injection of 1 cartridge articaine 4%) are write on separate papers and placed in the one sealed envelope, and another dentist colleague randomly takes out a number from the envelope for each patient and performs an injection based on that.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before each injection, another dentist will randomly take out a piece of paper and according to the number, he will inject one of the two anesthetic volumes, so that in the first group, 1.8 milliliter of 4% Articaine solution (one anesthetic cartridge and three minutes later, the needle will be inserted into the anesthetic area without injection) and the second group, 3.6 milliliter of 4% Articaine solution (two anesthetic cartridges three minutes apart) so that the operator and the patient are not aware of the anesthesia volume.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.RUMS.REC.1401.250

Health conditions studied

1

Description of health condition studied
Pain during root canal treatment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain during root canal treatment
Timepoint
During access hole preparation, dentin entry, pulp chamber entry or file placement
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
1st Intervention group: In the first group, infiltration injection of 1.8 milliliter of Articaine solution (Inibsa, Barcelona, Spain) is used. The treatment including access cavity preparation and root canal instrumentation were performed 6 minutes after the injection. Patients are taught to report any pain during each stage of preparation of the access hole and the entry of the instrument into the canal and cleaning and shaping to be recorded in the Heft-Parker visual analog pain scale (VAS) form.
Category
Treatment - Drugs

2

Description
Intervention group: : 2st Intervention group: In the second group, infiltration injection of 3.6 milliliter of Articaine solution (Inibsa, Barcelona, Spain) is used. The treatment including access cavity preparation and root canal instrumentation were performed 6 minutes after the injection. Patients are taught to report any pain during each stage of preparation of the access hole and the entry of the instrument into the canal and cleaning and shaping to be recorded in the Heft-Parker visual analog pain scale (VAS) form.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Ramin Abazarpoor
Street address
Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0040
Email
ram-aba@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Reza Vazirinezhad
Street address
Rafsanjan University of Medical Sciences, Imam Ali BLV
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0040
Email
rvazirinejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Yaghooti Khorasani
Position
Associated Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Shahid Mofateh Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0031
Fax
+98 34 3428 0008
Email
m_yaghooti@rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Yaghooti Khorasani
Position
Associated Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Shahid Mofateh Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0031
Fax
+98 34 3428 0008
Email
m_yaghooti@rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Yaghooti Khorasani
Position
Associated Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Shahid Mofateh Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0031
Fax
+98 34 3428 0008
Email
m_yaghooti@rums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
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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