NCT07409896

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Armed Forces Institute of Dentistry, Pakistan · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Anesthetic Efficacy

Interventions

Type	Name	Description
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 .
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-08-01
• Completion: 2027-02-01
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: Pakistan