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Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.

Primary Purpose

Success of Inferior Alveolar Nerve Block

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnesium sulfate
Mepivacaine-Levonordefrin Hydrochloride
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Success of Inferior Alveolar Nerve Block

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age between 18-55 years old.
  2. Systemically healthy patient (ASA I or II).

  3. Mandibular molar teeth with:

    • Preoperative sharp pain.
    • No widening in the periodontal ligament (PDL).
    • Vital response of pulp tissue to cold pulp tester (ethyl chloride spray)1.
    • Fully formed roots.
  4. Positive patient's acceptance for participation in the study.

Exclusion Criteria:

  1. Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment.
  2. Pregnant or nursing females.
  3. Patients having significant systemic disorder (ASA III or IV).
  4. Drug abusers and subjects who were on antidepressant medication.
  5. Re-treatment cases.
  6. Patients with a contraindication for the use of magnesium sulphate or those known to be allergic to any of the study medications.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    megnesium sulphate

    mepivacaine HCl

    Arm Description

    Injection of 1.8 mL of an anaesthetic solution containing 1% magnesium sulphate , and 1.8% mepivacaine HCL with .06mg Levonordefrin HCl during inferior alveolar nerve block.

    Injection of 1.8 mL of a local anaesthetic solution containing 1.8% mepivacaine HCL with .06mg Levonordefrin HCL during inferior alveolar nerve block

    Outcomes

    Primary Outcome Measures

    success of inferior alveolar nerve block measured using a numerical rating scale (NRS)
    Intensity of pain 15 minutes after injection during access cavity and initial file placement is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain )

    Secondary Outcome Measures

    Full Information

    First Posted
    September 20, 2020
    Last Updated
    September 26, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04561921
    Brief Title
    Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.
    Official Title
    Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 22, 2020 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    November 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    the study is conducted to assess the effect of adding magnesium sulphate to mepivacaine HCl compared to mepivacaine HCl alone on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Success of Inferior Alveolar Nerve Block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    megnesium sulphate
    Arm Type
    Experimental
    Arm Description
    Injection of 1.8 mL of an anaesthetic solution containing 1% magnesium sulphate , and 1.8% mepivacaine HCL with .06mg Levonordefrin HCl during inferior alveolar nerve block.
    Arm Title
    mepivacaine HCl
    Arm Type
    Active Comparator
    Arm Description
    Injection of 1.8 mL of a local anaesthetic solution containing 1.8% mepivacaine HCL with .06mg Levonordefrin HCL during inferior alveolar nerve block
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium sulfate
    Other Intervention Name(s)
    magnisol
    Intervention Description
    patients will be given an IANB injection by adding 0.18 mL of 10% magnesium sulphate to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe
    Intervention Type
    Drug
    Intervention Name(s)
    Mepivacaine-Levonordefrin Hydrochloride
    Other Intervention Name(s)
    Mepecaine - L
    Intervention Description
    patients will be given an IANB injection by adding 0.18 mL of sterile distilled water to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe
    Primary Outcome Measure Information:
    Title
    success of inferior alveolar nerve block measured using a numerical rating scale (NRS)
    Description
    Intensity of pain 15 minutes after injection during access cavity and initial file placement is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain )
    Time Frame
    15 minutes after injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age between 18-55 years old. Systemically healthy patient (ASA I or II). Mandibular molar teeth with: Preoperative sharp pain. No widening in the periodontal ligament (PDL). Vital response of pulp tissue to cold pulp tester (ethyl chloride spray)1. Fully formed roots. Positive patient's acceptance for participation in the study. Exclusion Criteria: Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment. Pregnant or nursing females. Patients having significant systemic disorder (ASA III or IV). Drug abusers and subjects who were on antidepressant medication. Re-treatment cases. Patients with a contraindication for the use of magnesium sulphate or those known to be allergic to any of the study medications.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    alaa Ib mekhimar, B.D.S
    Phone
    01096404006
    Ext
    002
    Email
    alaa.ibrahim.ghazy@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.

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