Comparation of infiltration anesthetic efficacy of 1.8 ml and 3.6 ml of articaine for mandibular incisor in irreversible pulpitis: A randomized clinical trial
Determining the success rate of infiltration anesthesia injection of one articaine cartridge in mandibular incisor teeth with irreversible pulpitis according to gender and age and determining the success rate of infiltration anesthesia injection of two articaine cartridges in mandibular incisor teeth with irreversible pulpitis According to gender and age and comparing the success rate of anesthetic solution in 2 studied groups.
Design
Randomised, parallel group trial with blinded outcome assessment. Randomisation will be written on pieces of paper and kept in sealed envelopes
Settings and conduct
The study will be performed by 2 dentists in a private clinic in Rafsanjan. After the anesthesia injection, patients and the operator are unaware (double-blinded). Patients are instructed to report any pain at any stage of treatment in Heft-Parker Visual Analog Scale form.
Participants/Inclusion and exclusion criteria
Healthy adult patients 18–60 years old having mandibular incisor tooth with symptomatic irreversible pulpitis and a normal periapical radiographic appearance
Intervention groups
In the 1st group, 3.6 ml of articaine solution (two anesthetic cartridges three minutes apart), in the second group, 1.8 ml of articaine solution (one anesthetic cartridge and three minutes later followed by a moking injection), 2-3 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:IRCT20091213002847N4
Registration date:2023-07-22, 1402/04/31
Registration timing:retrospective
Last update:2023-07-22, 1402/04/31
Update count:0
Registration date
2023-07-22, 1402/04/31
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
2023-06-16, 1402/03/26
Scientific title
Comparation of infiltration anesthetic efficacy of 1.8 ml and 3.6 ml of articaine for mandibular incisor in irreversible pulpitis: A randomized clinical trial
Public title
infiltration anesthetic efficacy of 1.8 ml and 3.6 ml of articaine for mandibular incisor in irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients
With Mandibular Incisor teeth with irreversible pulpitis and normal Periapical Radiography
Without Spontaneous pain that required Emergency treatment
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:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomizzation
The even and odd numbers from 1 to 88 (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
The numbers 1 to 88 are written on cards and placed inside an envelope, where even and odd numbers each represent one of the two volumes of anesthetic drug, which is chosen by another colleague by chance, and the corresponding injection is made by him until the patient and the operator. Do not know the amount of anesthetic.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan university of medical science
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.RUMS.REC.1401.251
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 the preparation of the access hole, entering the dentin, entering the pulp chamber or placing the file in the canal
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
1st Intervention group: The infiltration involved adeposition of 1.8 mL articaine (Xilonibsa, Inibsa, Barcelona, Spain) each patient received 1 cartridges of the anesthetic solution. The treatment including access cavity preparation and root canal instrumentation were performed 2-3 minutes after the injection. The patients were asked to rate their pain using a Heft-Parkervisual analog pain scale (VAS) before administration of the anesthetic solution and during the endodontic treatment.
Category
Treatment - Drugs
2
Description
2st Intervention group: The infiltration involved adeposition of 3.6 mL articaine (Xilonibsa, Inibsa, Barcelona, Spain) each patient received 2 cartridges of the anesthetic solution. The treatment including access cavity preparation and root canal instrumentation were performed 2-3 minutes after the injection. The patients were asked to rate their pain using a Heft-Parkervisual analog pain scale (VAS) before administration of the anesthetic solution and during the endodontic treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Ramin Abazarpoor
Street address
Imam Khomeini
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3424 2322
Email
ram-aba@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinezhad (Vice President of Research and Technology of RUMS)
Street address
Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0040
Email
vcrt@rums.ac.ir
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 Yaaghooti Khorasani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Endodontics
Street address
Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0040
Email
m.yaghooti@yahoo.com
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
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
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)
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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers in the fields of medical sciences
Under which criteria data/document could be used
There is no limit
From where data/document is obtainable
Email to Mohammad Mahdi Yaaghooti Khorasani
m.yaghooti@yahoo.com
What processes are involved for a request to access data/document
By emailing the scientific officer and requesting to receive information, the information will be sent to the sender's email within 15 days