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.

Success of Inferior Alveolar Nerve Block Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04561921
• Other study ID #: ENDO 3-7-1(18/9/20)
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: alaa Ib mekhimar, B.D.S
• Phone: 01096404006
• Email: alaa.ibrahim.ghazy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: November 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Success of Inferior Alveolar Nerve Block

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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