NCT07409896

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

December 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 7, 2025

Last Update Submit

February 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Duration of anesthesia

    1 hour 30 mins

Study Arms (2)

ARM 1 : 2%Lignocaine 1:80,000 epinephrine

ACTIVE COMPARATOR

: 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

ARM 2 : 4% Articaine with 1:100,000 epinephrine

ACTIVE COMPARATOR

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

Interventions

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.

ARM 2 : 4% Articaine with 1:100,000 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 .

ARM 1 : 2%Lignocaine 1:80,000 epinephrine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute of Dentistry AFID CMH Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Links

MeSH Terms

Interventions

LidocaineEpinephrine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Dr. Sadia Shehzadi Dr. Sadia Shehzadi, BDS,FCPS(PG3)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the type of local anesthetic technique administered. They will not be informed whether they received an IANB with 2% Lignocaine or Buccal Infilteration with 4% Articaine. The operator and investigator can not be blindeddue to the nature of the procedure.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sadia Shehzadi

Study Record Dates

First Submitted

December 7, 2025

First Posted

February 13, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations