Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis

Overview

The study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block) will be anesthetized using 4% articaine 1:100.000 plus cryotherapy application, and the second group (experimental group) will be anaesthetised with IANB plus buccal infiltration. For the third group (control group), the mandibular molars will be anaesthetized using epinephrine using the inferior alveolar nerve block.

Full Title of Study: “Evaluation of Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Parallel Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 18, 2022

Interventions

  • Procedure: Cryotherapy
    • Ice packs application for 5 minutes after IANB injection
  • Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine
    • Buccal infiltration after IANB

Arms, Groups and Cohorts

  • Experimental: Cryotherapy
  • Experimental: IANB plus buccal infiltration local anesthesia
  • Active Comparator: IANB

Clinical Trial Outcome Measures

Primary Measures

  • Pain assessment
    • Time Frame: up to 24 hours
    • verbal rating scale (VRS) withh the following scores: Score 0: no pain, Score 1: mild pain, Score 2: moderate pain, and Score 3: severe pain.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients aged above 18 years – Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis Exclusion Criteria:

  • Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions – Presence of paresthesia – Presence of psychological problems – Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Minia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmad Elheeny, Assistant Professor – Minia University
  • Overall Contact(s)
    • Ahmad Elheeny, PhD, 00201064257135, ahmedelheeny@mu.edu.eg

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