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Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain

Primary Purpose

Irreversible Pulpitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bupivacaine plus mannitol
bupivacaine alone
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring inferior alveolar nerve block, long-acting local anesthesia, bupivacaine, mannitol, symptomatic irreversible pulpitits

Eligibility Criteria

17 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients; age between 17-35 years old.
  2. Males or Females.
  3. Medically-free patients
  4. Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth.
  5. Positive patients' acceptance for participation in the study.

Exclusion Criteria:

  • Patients who had any analgesic during proceeding 12 hours before the treatment.
  • Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis (apical abscess).
  • Pregnant females.
  • Patients with history of significant medical conditions (contraindication of mannitol use).
  • Addiction
  • Psycological disturbance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    bupivacaine plus mannitol

    bupivacaine alone

    Arm Description

    0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol

    0.5% bupivacaine with 1:200,000epinephrine alone

    Outcomes

    Primary Outcome Measures

    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain

    Secondary Outcome Measures

    Anesthetic success
    yes or no
    lip numbness duration
    recorded in hours
    Medication intake
    yes or no

    Full Information

    First Posted
    November 15, 2018
    Last Updated
    November 20, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03749408
    Brief Title
    Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain
    Official Title
    Effect of Addition of 0.5 Mol/L Mannitol to 0.5% Bupivacaine on IANB Success and Post-endodontic Pain in Mandibular Molars With Irreversible Pulpitis: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2012 (Actual)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol in patients with irreversible pulpitis in mandibular molars.
    Detailed Description
    Patients with irreversible pulpitis in mandibular molars will be selected according to the eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irreversible Pulpitis
    Keywords
    inferior alveolar nerve block, long-acting local anesthesia, bupivacaine, mannitol, symptomatic irreversible pulpitits

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    bupivacaine plus mannitol
    Arm Type
    Active Comparator
    Arm Description
    0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol
    Arm Title
    bupivacaine alone
    Arm Type
    Experimental
    Arm Description
    0.5% bupivacaine with 1:200,000epinephrine alone
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine plus mannitol
    Other Intervention Name(s)
    vivacaine plus mannitol
    Intervention Description
    local anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine alone
    Other Intervention Name(s)
    vivacaine
    Intervention Description
    local anesthesia
    Primary Outcome Measure Information:
    Title
    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    Description
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
    Time Frame
    6 hours
    Title
    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    Description
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
    Time Frame
    12 hours
    Title
    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    Description
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
    Time Frame
    24 hours
    Title
    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    Description
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
    Time Frame
    48 hours
    Title
    Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
    Description
    using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
    Time Frame
    72 hours
    Secondary Outcome Measure Information:
    Title
    Anesthetic success
    Description
    yes or no
    Time Frame
    1 hour
    Title
    lip numbness duration
    Description
    recorded in hours
    Time Frame
    24 hours
    Title
    Medication intake
    Description
    yes or no
    Time Frame
    72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients; age between 17-35 years old. Males or Females. Medically-free patients Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth. Positive patients' acceptance for participation in the study. Exclusion Criteria: Patients who had any analgesic during proceeding 12 hours before the treatment. Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis (apical abscess). Pregnant females. Patients with history of significant medical conditions (contraindication of mannitol use). Addiction Psycological disturbance.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain

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