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Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

Primary Purpose

Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
local anaesthetic injection
Sponsored by
Dr. Vivek Aggarwal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • active pain in a mandibular molar
  • prolonged response to cold testing with an ice stick and an electric pulp tester
  • absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
  • vital coronal pulp on access opening and ability to understand the use of pain scales

Exclusion Criteria:

  • known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
  • history of active peptic ulcer within the preceding 12 months
  • history of bleeding problems or anticoagulant use within the last month
  • patients who were pregnant or breast-feeding
  • a history of known or suspected drug abuse
  • patients who had taken NSAIDs within 12 h before administration of the study drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Inferior Alveolar nerve block with 2% lidocaine with epinephrine

    Inferior Alveolar nerve block with 4% articaine with epinephrine

    Inferior Alveolar nerve block with 3% plain mepivacaine

    Arm Description

    An inferior alveolar nerve block was given with 2% lidocaine with epinephrine

    An inferior alveolar nerve block was given with 4% articaine with epinephrine

    An inferior alveolar nerve block was given with 3% plain mepivacaine

    Outcomes

    Primary Outcome Measures

    Anesthetic Success
    Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 24, 2022
    Last Updated
    February 3, 2022
    Sponsor
    Dr. Vivek Aggarwal
    Collaborators
    SGT DENTAL COLLEGE
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05239078
    Brief Title
    Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis
    Official Title
    Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    February 28, 2017 (Actual)
    Study Completion Date
    February 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr. Vivek Aggarwal
    Collaborators
    SGT DENTAL COLLEGE

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Pulpal and periapical inflammation and infection can cause tissue pH in the affected region to be lowered which results in less penetration of anesthetic solution in the nerve membrane and hence delays the onset of anesthesia. So, the purpose of this study was to compare the pulpal anesthetic efficacy of lidocaine, articaine, mepivacaine for inferior alveolar nerve block (IANB) in patients with irreversible pulpitis (IP). One hundred and twenty adult patients with IP concerning mandibular molars randomly received IANB with either of the three solutions: 2% lidocaine with epinephrine; 4% articaine with epinephrine; 3% plain mepivacaine. Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Endodontic treatment was initiated. Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation. The anesthetic success rates were analyzed with the chi-square test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inferior Alveolar nerve block with 2% lidocaine with epinephrine
    Arm Type
    Active Comparator
    Arm Description
    An inferior alveolar nerve block was given with 2% lidocaine with epinephrine
    Arm Title
    Inferior Alveolar nerve block with 4% articaine with epinephrine
    Arm Type
    Experimental
    Arm Description
    An inferior alveolar nerve block was given with 4% articaine with epinephrine
    Arm Title
    Inferior Alveolar nerve block with 3% plain mepivacaine
    Arm Type
    Experimental
    Arm Description
    An inferior alveolar nerve block was given with 3% plain mepivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    local anaesthetic injection
    Intervention Description
    Inferior alveolar nerve block
    Primary Outcome Measure Information:
    Title
    Anesthetic Success
    Description
    Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation.
    Time Frame
    15 minutes after the inferior alveolar nerve block

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: active pain in a mandibular molar prolonged response to cold testing with an ice stick and an electric pulp tester absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament vital coronal pulp on access opening and ability to understand the use of pain scales Exclusion Criteria: known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs history of active peptic ulcer within the preceding 12 months history of bleeding problems or anticoagulant use within the last month patients who were pregnant or breast-feeding a history of known or suspected drug abuse patients who had taken NSAIDs within 12 h before administration of the study drugs

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

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