To compare the anesthetic efficacy of articaine with lidocaine as an inferior nerve blocking agent in subjects with symptomatic irreversible pulpitis.
Design
Two arm, parallel group, double blind randomised control trial
Settings and conduct
Eligible subjects reporting to department of Operative Dentistry, Islamic International Dental Hospital (IIDH), Islamabad, during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through randomization software. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the anesthetic solution used.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Subjects of both genders, in good health, with no systemic disease that will interfere with the action of any of the anesthetic solutions being used, aged between 26 – 35 years. Mandibular posterior teeth requiring endodontic treatment due to symptomatic irreversible pulpitis, with no previous attempts of endodontic therapy on that tooth, positive to pulp sensibility testing (cold testing).
Exclusion Criteria: Patients who have known allergy to amides or are taking any medication that will alter their perception of pain, patients suffering from any heart disease, diabetes mellitus, female patients who are pregnant.
Intervention groups
Intervention group: subjects receiving articaine (1.7 ml of Septanest SP 4% articaine with 1:100,000 epinephrine each) as inferior nerve blocking agent
Control group: subjects receiving lidocaine (1.7 ml of Lignospan standard 2% lidocaine with 1:100,000 epinephrine each) as inferior nerve blocking agent
Main outcome variables
Pain relief after anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211230053569N1
Registration date:2023-04-11, 1402/01/22
Registration timing:retrospective
Last update:2023-04-11, 1402/01/22
Update count:0
Registration date
2023-04-11, 1402/01/22
Registrant information
Name
Sobia Hassan
Name of organization / entity
Riphah International University, Islamabad
Country
Pakistan
Phone
+92 51 2890690
Email address
sobiabostan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-01, 1401/05/10
Expected recruitment end date
2022-08-30, 1401/06/08
Actual recruitment start date
2022-08-01, 1401/05/10
Actual recruitment end date
2022-08-30, 1401/06/08
Trial completion date
2022-08-30, 1401/06/08
Scientific title
Comparison of anesthetic efficacy of articaine with lidocaine as an inferior nerve blocking agent in subjects with symptomatic irreversible pulpitis
Public title
Anesthetic efficacy of articaine with lidocaine in symptomatic irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects of both genders (males and females), in good health, with no systemic disease that will interfere with the action of any of the anesthetic solutions being used, aged between 26 – 35 years
Mandibular posterior teeth requiring endodontic treatment due to symptomatic irreversible pulpitis
There should have been no previous attempts of endodontic therapy on that tooth
Positive pulp sensibility testing (cold testing)
Exclusion criteria:
Patients who have known allergy to amides
Patients taking any medication that will alter their perception of pain
Patients who are suffering from any heart disease, diabetes mellitus
Female patients who are pregnant
Age
From 26 years old to 35 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
152
Actual sample size reached:
152
Randomization (investigator's opinion)
Randomized
Randomization description
Before the experiment, each of the two anesthetic solutions will be labeled as A and B. Simple, individual randomization will be done and subjects will be randomly allocated either solution A or B, using online randomization software (OpenEpi)
Blinding (investigator's opinion)
Double blinded
Blinding description
Before the experiment, each of the two anesthetic solutions will be covered to conceal the name of the product and labeled as A and B respectively. Both the chief researcher and the patient will be unaware of which alphabet represents which solution.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic International Dental College
Street address
Street 41, off 7th Avenue, G-7/4
City
Islamabad
Postal code
44000
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IIDC/IRC/2020/001/012
Health conditions studied
1
Description of health condition studied
Symptomatic irreversible pulpitis in posterior mandibular teeth
ICD-10 code
K04.02
ICD-10 code description
Irreversible pulpitis
Primary outcomes
1
Description
Pain relief after anesthesia
Timepoint
Immediately after intervention
Method of measurement
Visual Analogue Scale for pain assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: subjects diagnosed with symptomatic irreversible pulpitis (after taking history, carrying out cold testing and filling the Visual Analogue Scale to score pain levels) receiving 1.7 ml of 4% articaine with 1:100,000 epinephrine (Septanest SP) as inferior nerve blocking agent.
Category
Treatment - Drugs
2
Description
Control group: subjects diagnosed with symptomatic irreversible pulpitis (after taking history, carrying out cold testing and filling the Visual Analogue Scale to score pain levels) receiving 1.7 ml of 2% lidocaine with 1:100,000 epinephrine (Lignospan standard), as inferior nerve blocking agent.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic International Dental College
Full name of responsible person
Dr Sobia Bostan
Street address
Street 41, off 7th Avenue, G-7/4
City
Islamabad
Postal code
44000
Phone
+92 333 5526084
Email
sobia.hassan@riphah.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Dr Sobia Hassan
Street address
Street 41 A, 7th Avenue, G-7/4
City
Islamabad
Postal code
44000
Phone
+92 51 2891835
Email
sobia.hassan@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
100
Public or private sector
Private
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
Riphah International University
Full name of responsible person
Dr Sobia Hassan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Street 41A, 7th Avenue, G-7/4
City
Islamabad
Province
ICT
Postal code
44000
Phone
+92 51 2891835
Email
sobia.hassan@riphah.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Dr Sobia Hassan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Street 41A, 7th Avenue, G-7/4
City
Islamabad
Province
ICT
Postal code
44000
Phone
+92 51 2891835
Email
sobia.hassan@riphah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Dr Sobia Hassan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Street 41A, 7th Avenue, G-7/4
City
Islamabad
Province
ICT
Postal code
44000
Phone
+92 51 2891835
Email
sobia.hassan@riphah.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available