Investigating the success rate of infiltrating anesthetic injection of 1.8 ml of Articaine, injection of 1.8 ml of Articaine as mental block and injection of 1.8 ml of Lidocaine as mental block in mandibular incisor teeth with irreversible pulpitis: A randomized clinical trial
Determine success rate of infiltrating anesthetic injection of 1.8 ml of Articaine, injection of 1.8 ml of Articaine as mental block and injection of 1.8 ml of Lidocaine as mental block in mandibular incisor teeth with irreversible pulpitis
Design
Randomized, 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-blind). patients are instructed to report any pain at any stage of treatment in Visual Analogue Scale (VAS) form.
Participants/Inclusion and exclusion criteria
Inclusion citeria: Healthy adult patients 18 to 60 years old having mandibular canine with symptomatic irreversible pulpitis and normal periapical radiograph appearance Exclusion criteria: Increasing the width of the periodontal ligament or radiolucency in radiography; canine teeth sensitive to pressure; sensitivity to articaine 4% or lidocaine 2% or epinephrine; American Society of Anesthesiologists (ASA) III, IV patients; pregnancy or breastfeeding; Addicted patients
Intervention groups
In the first group, infiltrating of 1.8 ml of 4% Articaine solution, the second group of 1.8 ml of 4% Articaine solution as mental block and the third group of 1.8 ml of 2% Lidocaine solution as mental block . 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and 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
MINB,IP,PDL
IRCT registration information
IRCT registration number:IRCT20210515051306N3
Registration date:2023-07-16, 1402/04/25
Registration timing:prospective
Last update:2023-07-16, 1402/04/25
Update count:0
Registration date
2023-07-16, 1402/04/25
Registrant information
Name
Ramin Abazarpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3424 2322
Email address
abazarpoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the success rate of infiltrating anesthetic injection of 1.8 ml of Articaine, injection of 1.8 ml of Articaine as mental block and injection of 1.8 ml of Lidocaine as mental block in mandibular incisor teeth with irreversible pulpitis: A randomized clinical trial
Public title
The success rate of infiltrating anesthetic injection of 1.8 ml of Articaine, injection of 1.8 ml of Articaine as mental block and injection of 1.8 ml of Lidocaine as mental block in mandibular incisor teeth with irreversible pulpitis: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy adult patients 18_60 years old
Having a mandibular incisor tooth with symptomatic irreversible pulpitis
Normal periapical radiographic appearance
Exclusion criteria:
Patients under age of 18 and over the age of 60 years
American Society of Anesthesiologists (ASA) III,IV patients
Pregnancy or breasfeeding
Any type of medication that could potentially interact with the anesthetic solution
Spontaneous pain
Periodontal disease or unable to get restoration
Having pain killer late 12 hours
History of sensititivity to 4% articaine, 2% lidocaine or epinephrine
Widening PDL
Radiolucency in radiography
Incisor teeth sensitive to percussion
Addicted
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization individually
3 categories (Infiltrating anesthetic injection of 1.8 ml of Articaine, injection of 1.8 ml of Articaine as mental block and injection of 1.8 ml of Lidocaine as mental block ) were written on 165 pieces of paper and kept in sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The papers are placed in the envelope and before each injection, another dentist colleague takes them out by chance, and written injection is done by him so that the operator and patient are not aware of the type of anesthesia technique.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd , Centeral Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-06-24, 1402/04/03
Ethics committee reference number
IR.RUMS.REC.1402.041
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis of the mandibular incisor
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain score during treatment on Visual Analogue Scale (VAS)
Timepoint
Before administration of the anesthetic solution and during root canal treatment
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group: The first group of infiltrating anesthetic injection of 1.8 ml of 4% articaine solution with 1.100000 epinephrine, using the methods mentioned in Malamed. 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and if the answer is positive, the tooth is isolated by a rubber band, and the caries is removed. The access hole is prepared and root canal preparation is done. Patients are taught to report any pain during each stage of the preparation of the access hole and the entry of the instrument into the canal and cleaning to be recorded in the VAS form.
Category
Treatment - Drugs
2
Description
Intervention group: Second intervention group: The second group of mental nerve block is injected with 1.8 ml of 4% articaine solution with 1.100000 epinephrine, using the methods mentioned in Malamed. 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and if the answer is positive, the tooth is isolated by a rubber band, and the caries is removed. The access hole is prepared and root canal preparation is done. Patients are taught to report any pain during each stage of the preparation of the access hole and the entry of the instrument into the canal and cleaning to be recorded in the VAS form.
Category
Treatment - Drugs
3
Description
Intervention group: The third intervention group: The third group of mental nerve block is injected with 1.8 ml of 2% lidocaine solution with 1.100000 epinephrine, using the methods mentioned in Malamed. 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and if the answer is positive, the tooth is isolated by a rubber band, and the caries is removed. The access hole is prepared and root canal preparation is done. Patients are taught to report any pain during each stage of the preparation of the access hole and the entry of the instrument into the canal and cleaning to be recorded in the VAS form.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private Clinic
Full name of responsible person
Ramin Abazarpoor
Street address
Imam Khomeini Blvd., 37 Alley
City
Rafsanjan
Province
Kerman
Postal code
7713816120
Phone
+98 34 3425 2366
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 Vazirinejad
Street address
Khalij-e fars Blvd., Medical School
City
Rafsanjan
Province
Kerman
Postal code
37718175911
Phone
+98 34 3131 5512
Email
rvazirinejad@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Ramin Abazarpoor
Full name of responsible person
Rafsanjan University of Medical Sciences
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Khalij-e fars Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
Email
ram_aba@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ramin Abazarpoor
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khalij-e fars Blvd. Dentistry Faculty
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3424 2322
Email
abazarpoor@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ramin Abazarpoor
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khalij-e fars Blvd., Dentistry Faculty
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3424 2322
Email
abazarpoor@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