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

NCT03262857 | Completed Phase 2

• 1 other identifier: IUMS 396169
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Local Anesthesia

Keywords

magnesium sulfate; pulpitis; anesthesia

Outcome Measures

Primary Outcomes (2)

• Effect of Magnesium with lidocaine

  measuring the time of starting of anesthesia with questionnaire

  10 to 20 minute

• intensity of pain

  measuring pain after access cavity preparation with questionnaire

  10-20 minute

Study Arms (2)

time of start of anesthesia

EXPERIMENTAL

Drug: use of magnesium sulfate with lidocaine in inferior alveolar nerve block

intensity of anesthesia

EXPERIMENTAL

Drug: use of magnesium sulfate with lidocaine in inferior alveolar nerve block

Interventions

use of magnesium sulfate with lidocaine in inferior alveolar nerve block DRUG

intensity of anesthesia; time of start of anesthesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

MeSH Terms

Conditions

Pulpitis

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Endodontics

Study Record Dates

• First Submitted: August 19, 2017
• First Posted: August 25, 2017
• Study Start: September 21, 2016
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: August 12, 2019

Record last verified: 2019-08