Comparative evaluation of anesthetic efficacy of 1.8 mL articaine, 1.8 mL and 3.6 mL of lidocaine for mental nerve block in mandibular premolar with irreversible pulpitis
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 1.8 lidocaine 2% mental nerve block in mandibular premolar with irreversible pulpitis by age and gender
Determine success rate of 3.6 lidocaine 2% mental nerve block in mandibular premolar with irreversible pulpitis by age and gender
Comparison of success rate in all 3 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, 3.6 ml of 2% lidocaine solution (two anesthetic cartridges three minutes apart), in the second group, 1.8 ml of 4% articaine solution (one anesthetic cartridge and three minutes later followed by a moking injection), the third group 1.8 ml of 2% lidocaine solution (an 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:IRCT20210515051306N1
Registration date:2021-07-07, 1400/04/16
Registration timing:registered_while_recruiting
Last update:2021-07-07, 1400/04/16
Update count:0
Registration date
2021-07-07, 1400/04/16
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
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of anesthetic efficacy of 1.8 mL articaine, 1.8 mL and 3.6 mL of lidocaine for mental nerve block in mandibular premolar with irreversible pulpitis
Public title
anesthetic efficacy of 1.8 mL articaine, 1.8 mL and 3.6 mL of lidocaine for mental nerve block in irreversible pulpitis of the mandibular premolar
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
Care provider
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomizzation individually
3 categories (1.8 lidocaine, 1.8 articaine and 3.6 lidocaine) were written on 165 pieces 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
2021-06-22, 1400/04/01
Ethics committee reference number
IR.RUMS.REC.1400.053
Health conditions studied
1
Description of health condition studied
irreversible pulpitis of the mandibular premolar
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 the endodontic treatment
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
1st Intervention group: The mental nerve block involved adeposition of 1.8 mL 2% lidocaine with1:80,000 epinephrine (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
2
Description
2nd 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
3
Description
3rd Intervention group: The mental nerve block involved adeposition of 1.8 mL 2% lidocaine with1:80,000 epinephrine (Xilonibsa, 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
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
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
Fax
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
Fax
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