Anesthetic Efficacy of 1.8 ml Versus 3.6 ml of 4% Articaine Buccal Infiltration

Anesthetic Efficacy of 1.8 ml Compared to 3.6 ml of Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

The aim of the study is to compare the anesthetic efficacy and need for supplemental anesthesia of 1.8 ml compared to 3.6 ml of 4% articaine buccal infiltration in mandibular molars with symptomatic irreversible pulpitis.

Study Overview

• Status: Not yet recruiting
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Drug: 1.8 ml 4% Articaine hydrochloride; Drug: 3.6 ml 4% Articaine hydrochloride

Detailed Description

Patients with moderate-to-severe pain due to symptomatic irreversible pulpitis will be included. Patients will be randomly assigned into two groups to receive either 1.8 ml 4% articaine buccal infiltration or 3.6. ml 4% articaine buccal infiltration before single visit root canal treatments. Intraoperative pain will be assessed using an 11-point numerical rating scale (NRS) so that anesthetic success will be defined as no to mild intraoperative pain. The need for supplemental anesthesia will also be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hebatullah Moheb Ibrahim; Phone Number: 00201114563058; Email: heba.eid@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists (ASA class I or II).
2. No sex predilection
3. Patients with symptomatic irreversible pulpitis
4. Patient with the ability to understand and use pain scales.
5. Patients who accept to enroll in the study.

Exclusion Criteria:

1. Patients' allergies to any of the drugs or materials used in the study.
2. Pregnant and lactating females.
3. Patients taking analgesics in the last 6-8 hours.
4. Patients having more than one symptomatic tooth in the same quadrant

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1.8 ml 4% articaine buccal infiltration.	Drug: 1.8 ml 4% Articaine hydrochloride; 1.8 ml 4% articaine buccal infiltration
Experimental: 3.6 ml 4% articaine buccal infiltration	Drug: 3.6 ml 4% Articaine hydrochloride; 3.6 ml 4% articaine buccal infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthetic success	Will be measured by 11-point numerical rating scale NRS. The success will be defined as no or mild pain (NRS 0 or less than 3) and the failure will be defined as moderate to severe pain (NRS more than 3).	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for supplemental anesthesia	Whether the patient requires supplemental anesthesia or not. It will be recorded by the questionnaire (yes or no).	During the procedure

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.
• Poorni S, Veniashok B, Senthilkumar AD, Indira R, Ramachandran S. Anesthetic efficacy of four percent articaine for pulpal anesthesia by using inferior alveolar nerve block and buccal infiltration techniques in patients with irreversible pulpitis: a prospective randomized double-blind clinical trial. J Endod. 2011 Dec;37(12):1603-7. doi: 10.1016/j.joen.2011.09.009.
• Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

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; Carticaine
• Other Study ID Numbers: CU-Endo.23.10.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No