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.

NCT ID: NCT04561921

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2021-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

megnesium sulphate

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.

Group Type: EXPERIMENTAL

Magnesium sulfate

Intervention Type: 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

mepivacaine HCl

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

Group Type: ACTIVE_COMPARATOR

Mepivacaine-Levonordefrin Hydrochloride

Intervention Type: 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

Interventions

Magnesium sulfate

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

Intervention Type: DRUG

Mepivacaine-Levonordefrin Hydrochloride

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

Intervention Type: DRUG

Other Intervention Names

magnisol; Mepecaine - L

Eligibility Criteria

Inclusion Criteria

1. Age between 18-55 years old.

2. Systemically healthy patient (ASA I or II).

3. 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.

4. Positive patient's acceptance for participation in the study.

Exclusion Criteria

1. Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment.

2. Pregnant or nursing females.

3. Patients having significant systemic disorder (ASA III or IV).

4. Drug abusers and subjects who were on antidepressant medication.

5. Re-treatment cases.

6. Patients with a contraindication for the use of magnesium sulphate or those known to be allergic to any of the study medications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Ibrahim Ibrahim Ghazy Mekhimar

Resident at faculty of dentistry, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

alaa Ib mekhimar, B.D.S

Role: CONTACT

alaa.ibrahim.ghazy@gmail.com

01096404006 ext. 002

Other Identifiers

ENDO 3-7-1(18/9/20)

Identifier Type: -

Identifier Source: org_study_id