Volume Increase Versus Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success

Effect of Volume Increase Compared to Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success in Cases With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

To assess the anesthetic success of inferior alveolar nerve block (IANB), intraoperative pain intensity and need for supplemental anesthesia on administration of 1.8ml or 3.6ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine buccal infiltration (BI) in mandibular molars with symptomatic irreversible pulpitis.

Study Overview

• Status: Not yet recruiting
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Drug: 1.8 ml mepivacaine hydrochloride; Drug: 3.6 ml mepivacaine hydrochloride; Drug: 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI

Detailed Description

Patients with moderate-to-severe preoperative pain related to mandibular molars with symptomatic irreversible pulpitis will be included. Patients receive 1.8 ml, 3.6 ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine BI. Anesthetic success of inferior alveolar nerve block, intraoperative pain intensity and need for supplemental anesthesia will be assessed during treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reham Anwar Sleem; Phone Number: 00201014110666; Email: reham.anwar@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients in good health (ASA Class I, II).
2. Age between 18-60 years old.
3. Males or females.
4. Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
5. Patients who can understand NRS scale and sign the informed consent.

Exclusion Criteria:

1. Patients who had used any type of analgesic medication during the preceding 8 hours before the treatment.
2. Pregnant or nursing females.
3. Patients with a contraindication for the use of mepivacaine, articaine or any used drug or material.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1.8 ml mepivacaine IANB	Drug: 1.8 ml mepivacaine hydrochloride; 1.8 ml mepivacaine IANB
Experimental: 3.6 ml mepivacaine IANB	Drug: 3.6 ml mepivacaine hydrochloride; 3.6 ml mepivacaine IANB
Experimental: 1.8 ml mepivacaine IANB plus 1.8 ml articaine BI	Drug: 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI; 1.8 ml mepivacaine IANB plus 1.8 ml articaine BI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthetic success	Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.	During the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative pain	Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain".	During the treatment
Need for supplemental anesthesia	Whether the patient requires supplemental anesthesia or not	During the treatment

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Abazarpoor R, Parirokh M, Nakhaee N, Abbott PV. A Comparison of Different Volumes of Articaine for Inferior Alveolar Nerve Block for Molar Teeth with Symptomatic Irreversible Pulpitis. J Endod. 2015 Sep;41(9):1408-11. doi: 10.1016/j.joen.2015.05.015. Epub 2015 Jul 3.
• Aggarwal V, Singla M, Miglani S, Kohli S, Singh S. Comparative evaluation of 1.8 mL and 3.6 mL of 2% lidocaine with 1:200,000 epinephrine for inferior alveolar nerve block in patients with irreversible pulpitis: a prospective, randomized single-blind study. J Endod. 2012 Jun;38(6):753-6. doi: 10.1016/j.joen.2012.02.003. Epub 2012 Mar 3.
• Parirokh M, Satvati SA, Sharifi R, Rekabi AR, Gorjestani H, Nakhaee N, Abbott PV. Efficacy of combining a buccal infiltration with an inferior alveolar nerve block for mandibular molars with irreversible pulpitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):468-73. doi: 10.1016/j.tripleo.2009.11.016.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Mepivacaine; Carticaine
• Other Study ID Numbers: CU-ENDO-2-2-2022.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No