Comparison of Anesthetic Efficacy OF 2% Lidocaine Inferior Alveolar Nerve (IANB) Block Versus Primary Buccal Infilteration With 4% Articaine in Symptomatic Irreversible Pulpitis(SIP) IN Mandibular First Molars (IANB SIP EPT)

This randomized controlled trial aims to compare the anesthetic efficacy of 2% lignocaine administered through an inferior alveolar nerve block (IANB) in one group of participants with 4% articaine delivered via primary buccal infiltration in other group in patients with symptomatic irreversible pulpitis in mandibular first molars.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthetic Efficacy
• Intervention / Treatment: Other: INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine; Other: INTERVENTION 2 : 4%Articaine 1:100,000 epinephrine

Detailed Description

This single-blinded randomized controlled trial evaluates the comparative anesthetic efficacy of two routinely used local anesthetic techniques for mandibular first molars diagnosed with symptomatic irreversible pulpitis. Inferior alveolar nerve block (IANB) using 2% lidocaine is a standard but technique-sensitive approach with reported failure rates of 20-25%, often influenced by anatomical variations and pulpal inflammation. Primary buccal infiltration with 4% articaine has emerged as a promising alternative due to superior bone penetration and favorable clinical outcomes in several studies, though evidence in adult South Asian populations remains limited.

A total of 330 systemically healthy adults (ASA I, aged 18-55 years) meeting strict diagnostic criteria for symptomatic irreversible pulpitis will be enrolled. Participants will be randomized into two groups:

• Group 1: 2% lidocaine (1:80,000 epinephrine) via IANB
• Group 2: 4% articaine (1:100,000 epinephrine) via primary buccal infiltration

All injections will be standardized to 1.8 mL delivered over 60 seconds using 27-gauge needles by a single experienced clinician. Topical anesthesia with benzocaine 20% will be used prior to injection. Dental anxiety will be screened using Corah's DAS, and patients with high or phobic anxiety scores will be excluded.

Fifteen minutes after administration, soft-tissue anesthesia will be confirmed (lip numbness for IANB and buccal probe response for infiltration). Pulpal anesthesia will be objectively assessed using an electric pulp tester (EPT) and subjectively using the Heft-Parker Visual Analogue Scale (VAS) at multiple treatment stages: baseline, post-injection, access preparation, pulp chamber entry, and root canal instrumentation.

Anesthetic success will be defined as:

• Two consecutive non-responsive EPT readings (max output 80)
• Mild or no pain during the procedure (VAS <55 mm)

Failure will be recorded if moderate/severe pain (VAS ≥55 mm) occurs at any stage or supplemental anesthesia is required.

The study aims to determine whether 4% articaine buccal infiltration can provide anesthetic efficacy equal to or superior to 2% lidocaine IANB for endodontic treatment of symptomatic mandibular first molars. The findings may help refine local anesthetic protocols and reduce the need for supplemental injections in challenging pulpal conditions.

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Sadia Shehzadi Dr. Sadia Shehzadi, BDS,FCPS(PG3); Phone Number: 03342073051; Email: sadiashehzadi321@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 46000
      • Armed Forces Institute of Dentistry AFID CMH Rawalpindi
      • Contact: Sadia Shehzadi; Email: sadiashehzadi321@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Systemically healthy patients classified as ASA I, aged 18-55 years.
• Permanent mandibular first molar tooth requiring endodontic therapy.
• Diagnosed with symptomatic irreversible pulpitis without swelling or sinus.
• Normal periapical radiographic appearance (no evidence of periapical pathology).
• Moderate pain as assessed by the Heft-Parker VAS (>54 mm and <114 mm).
• Lingering pain or prolonged response to cold testing (lasting more than 10 seconds).
• Positive response to electric pulp testing.
• Outcome assessed must be pulpal anesthesia

Exclusion Criteria:

• • Pregnant or lactating mothers.

  • Teeth with reversible pulpitis, previously treated, or with calcified canals.
  • Teeth with severe periodontal disease or periapical radiolucency.
  • Patients who have taken analgesics or anti-inflammatory drugs within 6 hours before the treatment visit.
  • Patients on medications that could potentially interact with the anesthetic solution (e.g., antihypertensives, anticoagulants).
  • History of allergy to 4% articaine, lidocaine, or epinephrine.
  • Systemic diseases, immunocompromised states, or significant anxiety/mental health disorders.
  • History of vasovagal syncope on local anesthetic administration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM 1 : 2%Lignocaine 1:80,000 epinephrine; : 2% Lignocaine Inferior Alveolar Nerve Block (IANB) Participants in this group will receive an inferior alveolar nerve block using 2% Lignocaine with 1:80,000 epinephrine.	Other: INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine; 2% Lignocaine Inferior Alveolar Nerve Block (IANB) : Participants in this group will receive an inferior alveolar nerve block using 2% Lignocaine with 1:80,000 epinephrine. The injection will be administered following standard IANB technique for mandibular first molars. The anesthetic efficacy will be assessed with 2 consecutive non responsive readings on EPT objectivelt and via Heft-Parker VAS not more than ≥55 .
Active Comparator: ARM 2 : 4% Articaine with 1:100,000 epinephrine; Participants in this group will receive 4% Articaine with 1:100,000 epinephrine at the site of the mandibular first molar.	Other: INTERVENTION 2 : 4%Articaine 1:100,000 epinephrine; Participants in this group will receive a buccal infiltration of 4% Articaine with 1:100,000 epinephrine at the site of the mandibular first molar. The injection will follow standard buccal infiltration technique. Anesthetic efficacy will be evaluated during endodontic treatment using the same pain assessment method as Arm 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthetic efficacy	Description: Patients will be assigned to one of the two groups . Group 1: 2%Lignocaine 1;80,000 epinephrine 1.8 ml IANB Group 2: 4%Articaine 1:100,000 epinephrine 1.8 ml Primary buccal infilteration Efficacy will be considered if there are 2 consecutive non-responsive readings during 60 mins duration , usually measured on EPT 15 mins after administration of anesthesia . Any pain felt during the procedure will be measured according to Heft-Parker VAS and moderate-severe pain reported (VAS ≥ 55) will be regarded unsuccessful . Time Frame: 1 hour after administration of local anesthetic agent .	1 hour after administration of anesthetic agent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of anesthesia	Description: Duration up to which Lignocaine IANB/Articaine Primary Buccal Infilteration remains successful after administration . Time Frame: 1 hour 30 mins	1 hour 30 mins

Collaborators and Investigators

• Sponsor: Armed Forces Institute of Dentistry, Pakistan

Publications and helpful links

Helpful Links

• Comparison Of Anaesthetic Efficacy Of Articaine And Lidocaine In Nonsurgical Endodontic Treatment Of Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis. A Randomized Clinical Trial

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Lidocaine; Epinephrine
• Other Study ID Numbers: SS-ENDO-IANBART-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared because the study does not include plans or infrastructure for secure long term data storage, de-identification, and controlled access needed to protect participants privacy .Additionally, the data sheet is small and disclosure may include the risk of re-identification, summary results will be made available as required.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No