NCT06862570

Assessment of Local Anaesthesia Effectiveness in Symptomatic Irreversible Pulpitis

Assessment of Local Anaesthesia Effectiveness Using Electric Pulp Tester in Symptomatic Irreversible Pulpitis Using 2% Lignocaine and 4% Articaine As Supplemental Anaesthetic Agents: an in Vivo Comparison

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: 28 Military Dental Centre Lahore · Other Government
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the comparative efficacy of two different local anaesthetic agents for supplemental buccal infiltration after a failed inferior alveolar nerve block in achieving profound pulpal anaesthesia for symptomatic irreversible pulpitis using 2% lignocaine and 4% articaine with vasoconstrictor epinephrine. Alternate hypothesis: There is a mean difference in local anaesthesia effectiveness of 2% lignocaine and 4% articaine containing epinephrine when used for buccal infiltration in pulpectomy of symptomatic irreversible pulpitis of mandibular posterior teeth after a failed inferior alveolar nerve block

Detailed description

Patients diagnosed with symptomatic irreversible pulpitis are included in this study. Teeth will be divided into two groups after a failed inferior alveolar nerve block using 2% lignocaine containing 1:100,000 epinephrine. A sample size of 123, with the first group consisting of 62 patients, 2 cartridges of 32mg of 2% lignocaine with 1:100,000 epinephrine will be used for supplemental buccal infiltration. In group 2 of 61 patients, 40mg of 4% articaine with 1:100,000 epinephrine will be used. During the root canal treatment, a subjective assessment of lip anesthesia is recorded. An electric pulp tester is used for the evaluation of the presence or absence of pulpal anesthesia. A verbal analogue scale is also used to evaluate the presence or absence of pain. After taking a brief history, informed consent will be taken. A rubber dam will be used. Electric pulp tester will be used on the control contralateral tooth, the experimental tooth preoperatively; after giving nerve block and achieving Lip numbness, the experimental tooth will again be evaluated with Electric pulp tester. An access cavity will be made. If there is still no pulpal anesthesia, supplemental anesthesia will be administered and Electric pulp tester will be used again. A questionnaire containing a numerical rating scale will be given to each patient to record the intensity of pain felt after giving supplemental anesthesia.

Conditions

• Symptomatic Irreversible Pulpitis

Interventions

Type	Name	Description
DRUG	2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)	2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)
DRUG	4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)	4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

Timeline

• Start date: 2022-12-19
• Primary completion: 2023-05-19
• Completion: 2023-05-19
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study