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Local AnesthesiaPhase 2NCT03262857

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

A Phase 2 study testing use of magnesium sulfate with lidocaine in inferior alveolar nerve block in people with Local Anesthesia, run by Isfahan University of Medical Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Local Anesthesia
What is being tested?
use of magnesium sulfate with lidocaine in inferior alveolar nerve block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
No sites listed yet
Study dates
21 Sep 2016to 21 Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

About this study

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

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.

Read the 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.

Being tested
use of magnesium sulfate with lidocaine in inferior alveolar nerve block
Keywords
magnesium sulfate, pulpitis, anesthesia
Medical subject headings
Pulpitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • use of magnesium sulfate with lidocaine in inferior alveolar nerve blockDrug

Study groups in NCT03262857
Study groupRoleWhat they receive
time of start of anesthesiaExperimentalNot described
Receives: Drug: use of magnesium sulfate with lidocaine in inferior alveolar nerve block
intensity of anesthesiaExperimentalNot described
Receives: Drug: use of magnesium sulfate with lidocaine in inferior alveolar nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of Magnesium with lidocaine

    measuring the time of starting of anesthesia with questionnaire

    Measured: 10 to 20 minute

  2. intensity of pain

    measuring pain after access cavity preparation with questionnaire

    Measured: 10-20 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start21 Sep 2016
  3. Primary completion21 Sep 2018
  4. Study completion21 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03262857
Sponsor's protocol ID
IUMS 396169
Status last verified
Aug 2019
First submitted
19 Aug 2017
Last updated
12 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing use of magnesium sulfate with lidocaine in inferior alveolar nerve block in people with Local Anesthesia, run by Isfahan University of Medical Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Magnesium with lidocaine (time frame: 10 to 20 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.

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