Assessment of Local Anaesthesia Effectiveness in Symptomatic Irreversible Pulpitis

Phase 2

Completed

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Drug: 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)

• Registration Number: NCT06862570
• Lead Sponsor: 28 Military Dental Centre Lahore

Brief 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.

Study Timeline

• Study Start: 2022-12-19
• Primary Completion: 2023-05-19
• Study Completion: 2023-05-19
• Study First Submitted: 2025-02-25
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

1. Patients with ages ranging from 18-to 55 years
2. Male/ Female
3. Mandibular posterior teeth with symptomatic irreversible pulpitis
4. Ability to understand the use of the pain scale
5. Patients with adequate oral hygiene and willing to participate in the study

Exclusion Criteria

1. Any type of medication consumed before treatment
2. Patients who do not show profound lip numbness after giving inferior alveolar block
3. Periapical pathologies ( periapical abscess, sinus tract, periapical cyst, pulpal necrosis)
4. External resorption
5. Unfavorable location of the tooth, internal ankylosis, trismus, severe tooth malposition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2% LIGNOCAINE WITH EPINEPHRINE	2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)	1.8 ml of 2% Lignocaine with 1:100,000 epinephrine (36 mg/ml Lignocaine HCL, epinephrine bitartrate 0.0324 mg/ml)
4% ARTICAINE WITH EPINEPHRINE	4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)	1.7 ml of 4% Articaine with 1:100,000 epinephrine (40mg/ml Articaine HCL, epinephrine bitartrate 0.018mg/ml)

Primary Outcome Measures

Name	Time	Method
Assessment of Local anaesthsia effectiveness in symptomatic irreversible pulpitis after afailed inferior alveolar nerve block using supplemental buccal infiltration	5-10 minutes after administrating supplemental buccal infiltration	Numeric Rating scale to assess absence or presence of pain after supplemental buccal infiltration

Trial Locations

Locations (1)

Zahra Zubir; 🇵🇰 Lahore, Punjab, Pakistan