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NCT Number: NCT06862570

Assessment of Local Anaesthesia Effectiveness in Symptomatic Irreversible Pulpitis

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

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Key information

Conditions

Symptomatic Irreversible Pulpitis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zahra Zubir

Lahore, Punjab Province, 042, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)

Drug

2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)

Other names: HD caine Plus

4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

Drug

4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

Other names: Orabloc

Primary outcomes

  1. Assessment of Local anaesthsia effectiveness in symptomatic irreversible pulpitis after afailed inferior alveolar nerve block using supplemental buccal infiltration

    Time frame: 5-10 minutes after administrating supplemental buccal infiltration

    Numeric Rating scale to assess absence or presence of pain after supplemental buccal infiltration

Sponsors and collaborators

Lead sponsor

28 Military Dental Centre Lahore

Other Gov

Registry information

Official study title

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

Acronym: LA AGENTS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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