Warm Versus Conventional 2% Lignocaine for IANB Efficacy

January 31, 2025 updated by: Kanza Zafar, Armed Forces Institute of Dentistry, Pakistan

Comparative Evaluation of Anesthetic Efficacy of Warm and Conventional 2% Lignocaine for the Success of Inferior Alveolar Nerve Block (IANB) in Mandibular Permanent Molars: A Randomized Controlled Clinical Trial

The study compares the anesthetic efficacy of warm versus conventional 2% lignocaine for inferior alveolar nerve block in mandibular molars, evaluating success rates and onset time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted following approval from the Institutional Ethics Review Committee, AFID (ANX "A"). A total of 200 eligible patients visiting the Operative Dentistry Department at the Armed Forces Institute of Dentistry will be invited to participate. The procedure will be explained to the patients in Urdu, and written informed consent will be obtained (ANX "B").

Patients will be screened for eligibility through medical history, clinical examination, necessary tests, and peri-apical radiographs. Those meeting the inclusion criteria will be randomly assigned to one of two groups using a scientific random number table.

Group 1: Patients will receive conventional 2% lignocaine (at room temperature).

Group 2: Patients will receive pre-warmed 2% lignocaine (at 42°C). Root canal treatment will begin after the inferior alveolar nerve block (IANB) is administered. 1.8 mL of the local anesthetic will be delivered over 60 seconds using a 27-gauge needle. The first investigator will randomize participants by having them choose one of two differently colored balls to determine which anesthetic preparation (conventional or pre-warmed) they will receive. The conventional 2% lignocaine will be commercially available 2% lignocaine hydrochloride with 1:200,000 epinephrine, while the pre-warmed solution will be heated in a thermostatically controlled water bath or feeder bottle warmer (Philips AVENT) to 42°C.

The second investigator, who will be blinded to group allocation, will evaluate pain immediately after the block is administered by asking patients to rate their discomfort on a Visual Analog Scale (VAS). The onset of anesthesia will also be measured by performing gingival probing every 15 seconds. After rubber dam isolation, access cavity preparation will be performed, and pulp therapy will be initiated by the first investigator. The pulp therapy will be completed as needed, and the teeth will be restored with light-cured composite resin.

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Recruiting
        • Armed Forces Institute of Dentistry
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maha Ali Mirza, BDS

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:

  • Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
  • Patient who have carious mandibular molars.
  • Patients of either gender aged between 18-50 years old.
  • Systemically healthy patients.
  • Patients who agree to attend for recall appointments and provide a written consent

Exclusion Criteria:

  • Patients on preoperative analgesics and antibiotics.
  • Teeth with calcified canals and previously treated teeth.
  • Pregnant and lactating mothers.
  • Patients who are immunocompromised, anxious and mentally handicapped.
  • Patients who are allergic to lignocaine.
  • Non-vital or necrosed teeth.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional
Group 1: Patients receive conventional 2% lignocaine at room temperature.
Drug: conventional 2% lignocaine at room temperature
This study aims to compare the effectiveness of warm 2% lignocaine (lidocaine) versus conventional room temperature 2% lignocaine for achieving successful inferior alveolar nerve blocks (IANB) in mandibular permanent molars
Active Comparator: warm (42 celsius)
Group 2: Patients receive pre-warmed 2% lignocaine at 42°C
Drug: pre-warmed 2% lignocaine at 42°C
This study aims to compare the effectiveness of warm 2% lignocaine (lidocaine) versus conventional room temperature 2% lignocaine for achieving successful inferior alveolar nerve blocks (IANB) in mandibular permanent molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during administration of injection
Time Frame: 60 seconds
Pain during administration of injection with 2% conventional and warm lignocaine on visual analogue scale is assessed. Visual Analog Scale, which is a tool used to measure a patient's perception of pain. It typically consists of a line, often 10 cm long, where one end represents "no pain" and the other end represents "worst possible pain." The patient marks a point on the line that corresponds to their level of pain. The distance from the "no pain" end to the point marked by the patient is then measured, usually in centimeters or millimeters, to quantify the pain intensity. Visual Analog Scale is commonly used in clinical trials to assess pain during and after procedures, as it provides a simple and reliable method for evaluating pain intensity.
60 seconds
Onset of anesthesia in seconds
Time Frame: Every 15 seconds till patient reports no sensation after stimulus (assessed up to 15 minutes after anesthesia application)
It will be measured by gingival probing every 15 seconds till patient reports no sensation after stimulus (assessed up to 15 minutes after anesthesia application) It will be done by using both conventional and warm 2% lignocaine.
Every 15 seconds till patient reports no sensation after stimulus (assessed up to 15 minutes after anesthesia application)

Collaborators and Investigators

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

Sponsor

Armed Forces Institute of Dentistry, Pakistan

Investigators

  • Principal Investigator: Kanza Ali Zafar, BDS, AFID

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 15, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lignocaine Efficacy in IANB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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