Warm Versus Conventional 2% Lignocaine for IANB Efficacy

NCT06806202 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Lignocaine Efficacy in IANB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Success of Inferior Alveolar Nerve Block; Inferior Alveolar Nerve Block

Outcome Measures

Primary Outcomes (2)

• Pain during administration of injection

  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

  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)

Study Arms (2)

conventional

ACTIVE COMPARATOR

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

Drug: conventional 2% lignocaine at room temperature

warm (42 celsius)

ACTIVE COMPARATOR

Group 2: Patients receive pre-warmed 2% lignocaine at 42°C

Drug: pre-warmed 2% lignocaine at 42°C

Interventions

conventional 2% lignocaine at room temperature DRUG

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

conventional

pre-warmed 2% lignocaine at 42°C DRUG

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

warm (42 celsius)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

Armed Forces Institute Of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Kanza Ali Zafar, BDS

  AFID

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha Ali Mirza, BDS

CONTACT

00923337808809; mahaalimirza5@gmail.com

Kanza Zafar, BDS

CONTACT

00923337808809; kanzazafar6@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kanza Zafar, Principal Investigator and Resident Operative Dentistry and Endodontics

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: February 3, 2025
• Study Start: December 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)