<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262857</url>
  </required_header>
  <id_info>
    <org_study_id>IUMS 396169</org_study_id>
    <nct_id>NCT03262857</nct_id>
  </id_info>
  <brief_title>Effect of Lidocaine With Magnesium Sulfate on the Success of the Inferior Alveolar Nerve Block</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      68 healthy patients pulpitis and requiring root canal therapy are selected. . Sampling was&#xD;
      done in a simple and non-experimental way from a dental clinic in Isfahan, and then the&#xD;
      samples were randomly assigned to one of the two experimental groups (A, B) using simple&#xD;
      random numbers.&#xD;
&#xD;
      Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware&#xD;
      of the nature of the design and is not involved in the design, and each letter A or B is&#xD;
      written. This statement is not decoded after the statistical examination. Therefore, the&#xD;
      study is blind and blind. In this way, 60 patients are examined in 2 groups of 34 First,&#xD;
      patients with recognized pulpitis in mandibular posterior teeth have been identified and&#xD;
      information about them is given. Patients will be introduced to the executive phase after the&#xD;
      required explanation and clarification of the ambiguity and written consent. After completing&#xD;
      the patient information form by the practitioner and complying with all entry and exit&#xD;
      criteria, the study begins on each patient.&#xD;
&#xD;
      The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale&#xD;
      (VAS). This pain measurement method involves a 180 mm line with descriptive words that&#xD;
      differentiates patients on a line where the best describes their pain. In order to design a&#xD;
      standard injection of the maxillary nerve block in all patients, using Aspirating Dental&#xD;
      Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject,&#xD;
      Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed&#xD;
      with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above&#xD;
      the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the&#xD;
      tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of&#xD;
      the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the&#xD;
      syringe body in the perimmel area of the opposite side), and after the aspiration of the&#xD;
      contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of&#xD;
      numbness of the lips, the patient begins to study and the access cavity begins on the desired&#xD;
      tooth. In each of the stages of acquiring the access cavity or entering the initial file to&#xD;
      the canal, in the event of pain, the treatment is suspended and the patient signs his pain on&#xD;
      the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over.&#xD;
      In the absence of anesthetized lips, the patient is excluded from the study and after&#xD;
      completing the injection, the root canal is given.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      68 healthy patients (ASA I, II, and over the age of 18 and under the age of 60 years with&#xD;
      posterior mandibular maxillary jaw and with symptomatic pulpitis (severe and long response to&#xD;
      cold test) and requiring root canal therapy are selected. .&#xD;
&#xD;
      The criteria for entering the study include: absence of periodontal disease and any&#xD;
      periapical radiolucency except for PDL dilation, absence of susceptibility to local&#xD;
      anesthetic or sulfite drugs, non-pregnant women and non-lactating women, lack of drugs that&#xD;
      interact with local anesthetic Or change the perception of pain (such as beta-blocker drugs,&#xD;
      opiates, etc.).&#xD;
&#xD;
      Exclusion criteria included: Clinical observation of necrotic pulp after opening the access&#xD;
      cavity in the desired tooth, the patient's inability to give informed consent and patient's&#xD;
      continuation of the research in each stage of the trial.&#xD;
&#xD;
      Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan, and&#xD;
      then the samples were randomly assigned to one of the two experimental groups (A, B) using&#xD;
      simple random numbers.&#xD;
&#xD;
      Preparation of infiltration solution will be such that using a syringe with a high accuracy&#xD;
      (hamilton) of 0.2 ml of magnesium 10% sulfate vial or distilled water sterilized and then&#xD;
      into a 1.8ml cartridge of lidocaine 2% With an epinephrine 80000/1, the solution is shaken 5&#xD;
      times for mixing, so that no sediment should be seen.&#xD;
&#xD;
      Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware&#xD;
      of the nature of the design and is not involved in the design, and each letter A or B is&#xD;
      written. This statement is not decoded after the statistical examination. Therefore, the&#xD;
      study is blind and blind. In this way, 68 patients are examined in 2 groups of 34 people. It&#xD;
      should be noted that all anesthesia is injected by one person.&#xD;
&#xD;
      First, patients with recognized pulpitis in mandibular posterior teeth have been identified&#xD;
      and information about them is given. Patients will be introduced to the executive phase after&#xD;
      the required explanation and clarification of the ambiguity and written consent. After&#xD;
      completing the patient information form by the practitioner and complying with all entry and&#xD;
      exit criteria, the study begins on each patient.&#xD;
&#xD;
      The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale&#xD;
      (VAS). This pain measurement method involves a 180 mm line with descriptive words that&#xD;
      differentiates patients on a line where the best describes their pain. In order to design a&#xD;
      standard injection of the maxillary nerve block in all patients, using Aspirating Dental&#xD;
      Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject,&#xD;
      Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed&#xD;
      with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above&#xD;
      the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the&#xD;
      tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of&#xD;
      the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the&#xD;
      syringe body in the perimmel area of the opposite side), and after the aspiration of the&#xD;
      contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of&#xD;
      numbness of the lips, the patient begins to study and the access cavity begins on the desired&#xD;
      tooth. In each of the stages of acquiring the access cavity or entering the initial file to&#xD;
      the canal, in the event of pain, the treatment is suspended and the patient signs his pain on&#xD;
      the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over.&#xD;
      In the absence of anesthetized lips, the patient is excluded from the study and after&#xD;
      completing the injection, the root canal is given.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2016</start_date>
  <completion_date type="Actual">September 21, 2018</completion_date>
  <primary_completion_date type="Actual">September 21, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Magnesium with lidocaine</measure>
    <time_frame>10 to 20 minute</time_frame>
    <description>measuring the time of starting of anesthesia with questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>intensity of pain</measure>
    <time_frame>10-20 minute</time_frame>
    <description>measuring pain after access cavity preparation with questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Local Anesthesia</condition>
  <arm_group>
    <arm_group_label>time of start of anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>intensity of anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>use of magnesium sulfate with lidocaine in inferior alveolar nerve block</intervention_name>
    <arm_group_label>intensity of anesthesia</arm_group_label>
    <arm_group_label>time of start of anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  absence of periodontal disease&#xD;
&#xD;
          -  absence of susceptibility to local anesthetics or sulfite&#xD;
&#xD;
          -  non-pregnant women and non-lactating women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical observation of necrotic pulp&#xD;
&#xD;
          -  the patient's inability to give informed consent and patient's continuation of the&#xD;
             research in each stage of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Seyed Amir Mousavi</investigator_full_name>
    <investigator_title>Assistant Professor of Endodontics</investigator_title>
  </responsible_party>
  <keyword>magnesium sulfate</keyword>
  <keyword>pulpitis</keyword>
  <keyword>anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulpitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262857
org study id: IUMS 396169
nct id: NCT03262857
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Effect of Magnesium with lidocaine
time frame: 10 to 20 minute
description: measuring the time of starting of anesthesia with questionnaire
measure: intensity of pain
time frame: 10-20 minute
description: measuring pain after access cavity preparation with questionnaire
arm group label: time of start of anesthesia
arm group type: Experimental
arm group label: intensity of anesthesia
arm group type: Experimental
intervention type: Drug
intervention name: use of magnesium sulfate with lidocaine in inferior alveolar nerve block
arm group label: intensity of anesthesia
arm group label: time of start of anesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Seyed Amir Mousavi
investigator title: Assistant Professor of Endodontics
mesh term: Pulpitis
mesh term: Lidocaine
mesh term: Magnesium Sulfate