An interventional study of INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine and INTERVENTION 2 : 4%Articaine 1:100,000 epinephrine in Anesthetic Efficacy, sponsored by Armed Forces Institute of Dentistry, Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Armed Forces Institute of Dentistry, Pakistan · Not applicable, Interventional, and Health services research
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.
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:
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:
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.
Armed Forces Institute of Dentistry, Pakistan is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Pregnant or lactating mothers.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
: 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
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
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 .
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.
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 .
Time frame: 1 hour after administration of anesthetic agent
Duration of anesthesia
Description: Duration up to which Lignocaine IANB/Articaine Primary Buccal Infilteration remains successful after administration . Time Frame: 1 hour 30 mins
Time frame: 1 hour 30 mins
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Armed Forces Institute of Dentistry, Pakistan