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Effect of Lidocaine With Magnesium Sulfate on the Success of the Inferior Alveolar Nerve Block

Primary Purpose

Local Anesthesia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
use of magnesium sulfate with lidocaine in inferior alveolar nerve block
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Local Anesthesia focused on measuring magnesium sulfate, pulpitis, anesthesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • absence of periodontal disease
  • absence of susceptibility to local anesthetics or sulfite
  • non-pregnant women and non-lactating women

Exclusion Criteria:

  • Clinical observation of necrotic pulp
  • the patient's inability to give informed consent and patient's continuation of the research in each stage of the trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    time of start of anesthesia

    intensity of anesthesia

    Arm Description

    Outcomes

    Primary Outcome Measures

    Effect of Magnesium with lidocaine
    measuring the time of starting of anesthesia with questionnaire
    intensity of pain
    measuring pain after access cavity preparation with questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2017
    Last Updated
    August 8, 2019
    Sponsor
    Isfahan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03262857
    Brief Title
    Effect of Lidocaine With Magnesium Sulfate on the Success of the Inferior Alveolar Nerve Block
    Official Title
    Comparison of the Success Rate of Anesthesia Between Lidocaine 2% and Lidocaine 2% Mixed With 10% Magnesium Sulfate in the Inferior Alveolar Nerve Block in Posterior Teeth With Irreversible Pulpitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 21, 2016 (Actual)
    Primary Completion Date
    September 21, 2018 (Actual)
    Study Completion Date
    September 21, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Isfahan University of Medical Sciences

    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
    68 healthy patients pulpitis and requiring root canal therapy are selected. . Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan, and then the samples were randomly assigned to one of the two experimental groups (A, B) using simple random numbers. Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design, and each letter A or B is written. This statement is not decoded after the statistical examination. Therefore, the study is blind and blind. In this way, 60 patients are examined in 2 groups of 34 First, patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given. Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent. After completing the patient information form by the practitioner and complying with all entry and exit criteria, the study begins on each patient. The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale (VAS). This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain. In order to design a standard injection of the maxillary nerve block in all patients, using Aspirating Dental Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject, Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the syringe body in the perimmel area of the opposite side), and after the aspiration of the contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of numbness of the lips, the patient begins to study and the access cavity begins on the desired tooth. In each of the stages of acquiring the access cavity or entering the initial file to the canal, in the event of pain, the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over. In the absence of anesthetized lips, the patient is excluded from the study and after completing the injection, the root canal is given.
    Detailed Description
    68 healthy patients (ASA I, II, and over the age of 18 and under the age of 60 years with posterior mandibular maxillary jaw and with symptomatic pulpitis (severe and long response to cold test) and requiring root canal therapy are selected. . The criteria for entering the study include: absence of periodontal disease and any periapical radiolucency except for PDL dilation, absence of susceptibility to local anesthetic or sulfite drugs, non-pregnant women and non-lactating women, lack of drugs that interact with local anesthetic Or change the perception of pain (such as beta-blocker drugs, opiates, etc.). Exclusion criteria included: Clinical observation of necrotic pulp after opening the access cavity in the desired tooth, the patient's inability to give informed consent and patient's continuation of the research in each stage of the trial. Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan, and then the samples were randomly assigned to one of the two experimental groups (A, B) using simple random numbers. Preparation of infiltration solution will be such that using a syringe with a high accuracy (hamilton) of 0.2 ml of magnesium 10% sulfate vial or distilled water sterilized and then into a 1.8ml cartridge of lidocaine 2% With an epinephrine 80000/1, the solution is shaken 5 times for mixing, so that no sediment should be seen. Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design, and each letter A or B is written. This statement is not decoded after the statistical examination. Therefore, the study is blind and blind. In this way, 68 patients are examined in 2 groups of 34 people. It should be noted that all anesthesia is injected by one person. First, patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given. Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent. After completing the patient information form by the practitioner and complying with all entry and exit criteria, the study begins on each patient. The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale (VAS). This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain. In order to design a standard injection of the maxillary nerve block in all patients, using Aspirating Dental Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject, Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the syringe body in the perimmel area of the opposite side), and after the aspiration of the contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of numbness of the lips, the patient begins to study and the access cavity begins on the desired tooth. In each of the stages of acquiring the access cavity or entering the initial file to the canal, in the event of pain, the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over. In the absence of anesthetized lips, the patient is excluded from the study and after completing the injection, the root canal is given.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Local Anesthesia
    Keywords
    magnesium sulfate, pulpitis, anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    time of start of anesthesia
    Arm Type
    Experimental
    Arm Title
    intensity of anesthesia
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    use of magnesium sulfate with lidocaine in inferior alveolar nerve block
    Primary Outcome Measure Information:
    Title
    Effect of Magnesium with lidocaine
    Description
    measuring the time of starting of anesthesia with questionnaire
    Time Frame
    10 to 20 minute
    Title
    intensity of pain
    Description
    measuring pain after access cavity preparation with questionnaire
    Time Frame
    10-20 minute

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: absence of periodontal disease absence of susceptibility to local anesthetics or sulfite non-pregnant women and non-lactating women Exclusion Criteria: Clinical observation of necrotic pulp the patient's inability to give informed consent and patient's continuation of the research in each stage of the trial.

    12. IPD Sharing Statement

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    Effect of Lidocaine With Magnesium Sulfate on the Success of the Inferior Alveolar Nerve Block

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