Assessment of Local Anaesthesia Effectiveness in Symptomatic Irreversible Pulpitis (LA AGENTS)

March 4, 2025 updated by: Zahra Zubair, 28 Military Dental Centre Lahore

Assessment of Local Anaesthesia Effectiveness Using Electric Pulp Tester in Symptomatic Irreversible Pulpitis Using 2% Lignocaine and 4% Articaine As Supplemental Anaesthetic Agents: an in Vivo Comparison

This study aims to evaluate the comparative efficacy of two different local anaesthetic agents for supplemental buccal infiltration after a failed inferior alveolar nerve block in achieving profound pulpal anaesthesia for symptomatic irreversible pulpitis using 2% lignocaine and 4% articaine with vasoconstrictor epinephrine.

Alternate hypothesis:

There is a mean difference in local anaesthesia effectiveness of 2% lignocaine and 4% articaine containing epinephrine when used for buccal infiltration in pulpectomy of symptomatic irreversible pulpitis of mandibular posterior teeth after a failed inferior alveolar nerve block

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with symptomatic irreversible pulpitis are included in this study. Teeth will be divided into two groups after a failed inferior alveolar nerve block using 2% lignocaine containing 1:100,000 epinephrine. A sample size of 123, with the first group consisting of 62 patients, 2 cartridges of 32mg of 2% lignocaine with 1:100,000 epinephrine will be used for supplemental buccal infiltration. In group 2 of 61 patients, 40mg of 4% articaine with 1:100,000 epinephrine will be used. During the root canal treatment, a subjective assessment of lip anesthesia is recorded. An electric pulp tester is used for the evaluation of the presence or absence of pulpal anesthesia. A verbal analogue scale is also used to evaluate the presence or absence of pain.

After taking a brief history, informed consent will be taken. A rubber dam will be used. Electric pulp tester will be used on the control contralateral tooth, the experimental tooth preoperatively; after giving nerve block and achieving Lip numbness, the experimental tooth will again be evaluated with Electric pulp tester. An access cavity will be made. If there is still no pulpal anesthesia, supplemental anesthesia will be administered and Electric pulp tester will be used again.

A questionnaire containing a numerical rating scale will be given to each patient to record the intensity of pain felt after giving supplemental anesthesia.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 042
        • Zahra Zubir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients with ages ranging from 18-to 55 years
  2. Male/ Female
  3. Mandibular posterior teeth with symptomatic irreversible pulpitis
  4. Ability to understand the use of the pain scale
  5. Patients with adequate oral hygiene and willing to participate in the study

Exclusion Criteria:

  1. Any type of medication consumed before treatment
  2. Patients who do not show profound lip numbness after giving inferior alveolar block
  3. Periapical pathologies ( periapical abscess, sinus tract, periapical cyst, pulpal necrosis)
  4. External resorption
  5. Unfavorable location of the tooth, internal ankylosis, trismus, severe tooth malposition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2% LIGNOCAINE WITH EPINEPHRINE
1.8 ml of 2% Lignocaine with 1:100,000 epinephrine (36 mg/ml Lignocaine HCL, epinephrine bitartrate 0.0324 mg/ml)
Drug: 2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)
2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)
Other Names:
  • HD caine Plus
Experimental: 4% ARTICAINE WITH EPINEPHRINE
1.7 ml of 4% Articaine with 1:100,000 epinephrine (40mg/ml Articaine HCL, epinephrine bitartrate 0.018mg/ml)
Drug: 4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)
4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)
Other Names:
  • Orabloc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Local anaesthsia effectiveness in symptomatic irreversible pulpitis after afailed inferior alveolar nerve block using supplemental buccal infiltration
Time Frame: 5-10 minutes after administrating supplemental buccal infiltration
Numeric Rating scale to assess absence or presence of pain after supplemental buccal infiltration
5-10 minutes after administrating supplemental buccal infiltration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

28 Military Dental Centre Lahore

Investigators

  • Principal Investigator: Zahra Zubair, BDS, 28 Military Dental Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Actual)

May 19, 2023

Study Completion (Actual)

May 19, 2023

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL ANAESTHESIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Gender, tooth no.

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

zahra_zubair@hotmail.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe