Comparative evaluation of anesthetic efficacy of 1.8 mL articaine and 3.6 mL of articaine for mental nerve block in mandibular premolars with irreversible pulpitis: A randomized clinical trial study
Determine success rate of 1.8 articaine 4% mental nerve block in mandibular premolar with irreversible pulpitis by age and gender
Determine success rate of 3.6 articaine 4% mental nerve block in mandibular premolar with irreversible pulpitis by age and gender
Comparison of success rate in all 2 groups under investigation
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 VAS form.
Participants/Inclusion and exclusion criteria
Healthy adult patients 18–60 years old having mandibular premolar tooth with symptomatic irreversible pulpitis and a normal periapical radiographic appearance
Intervention groups
In the 1st group, 1.8 ml of 4% articaine solution (one anesthetic cartridge three minutes apart), in the second group, 3.6 ml of 4% 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
MINB
IRCT registration information
IRCT registration number:IRCT20210515051306N2
Registration date:2023-04-24, 1402/02/04
Registration timing:retrospective
Last update:2023-04-24, 1402/02/04
Update count:0
Registration date
2023-04-24, 1402/02/04
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
2022-12-01, 1401/09/10
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
2022-12-27, 1401/10/06
Actual recruitment end date
2023-04-04, 1402/01/15
Trial completion date
2023-04-04, 1402/01/15
Scientific title
Comparative evaluation of anesthetic efficacy of 1.8 mL articaine and 3.6 mL of articaine for mental nerve block in mandibular premolars with irreversible pulpitis: A randomized clinical trial study
Public title
Anesthetic efficacy of two different volumes of articaine for mental nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy adult patients 18–60 years old
Having a mandibular premolar tooth with symptomatic irreversible pulpitis
Normal periapical radiographic appearance
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 pain killer late 12 hours
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomizzation individually
3 categories (1.8 articaine, 3.6 articaine ) were written on 64pieces of paper and kept in sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The first practitioner who perform the local anesthetic injection will open the envelope, and based on the category each patient will receive either 2 cartridges of the anesthetic solution or a cartridge of the anesthetic solution followed by a mock injection. Another practitioner will perform the rest of the treatment including access cavity preparation and root canal instrumentation. Hence, the second practitioner and the patients won't be aware of the volume of anesthetic solution used.
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 Blv.
City
rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.RUMS.REC.1401.185
Health conditions studied
1
Description of health condition studied
irreversible pulpitis of the mandibular premolar
ICD-10 code
pulpitis
ICD-10 code description
k04.0
Primary outcomes
1
Description
Pain score during treatment on Visual Analogue Scale (VAS)
Timepoint
before administration of the anesthetic solution and during the endodontic treatment
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The mental nerve block involved a deposition of 1.8 mL 4% articaine with1:100,000 epinephrine (Artinibsa, Inibsa, Barcelona, Spain) each patient received a cartridge of the anesthetic solution followed by a mock injection. 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
Intervention group: The mental nerve block involved adeposition of 3.6mL 4% articaine with1:100,000 epinephrine (Artinibsa, 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
Private Clinic
Full name of responsible person
Ramin Abazarpoor
Street address
Dental Clinic, Sarallah St., Imam Khomeini Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7719757047
Phone
+98 34 3223 0488
Email
ram_aba@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Dentistry school, Khalij-e fars Blvd.
City
rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
Email
ram_aba@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
Ramin Abazarpoor
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