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.

NCT04561921 | Unknown

• 1 other identifier: ENDO 3-7-1(18/9/20)
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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

Conditions

Success of Inferior Alveolar Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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 )

  15 minutes after injection

Study Arms (2)

megnesium sulphate

EXPERIMENTAL

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.

Drug: Magnesium sulfate

mepivacaine HCl

ACTIVE COMPARATOR

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

Drug: Mepivacaine-Levonordefrin Hydrochloride

Interventions

Magnesium sulfate DRUG

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

Also known as: magnisol

megnesium sulphate

Mepivacaine-Levonordefrin Hydrochloride DRUG

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

Also known as: Mepecaine - L

mepivacaine HCl

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

alaa Ib mekhimar, B.D.S

CONTACT

01096404006; alaa.ibrahim.ghazy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at faculty of dentistry, Cairo University

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 24, 2020
• Study Start: October 22, 2020
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 29, 2020

Record last verified: 2020-09