Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Study

Pulpal and periapical inflammation and infection can cause tissue pH in the affected region to be lowered which results in less penetration of anesthetic solution in the nerve membrane and hence delays the onset of anesthesia. So, the purpose of this study was to compare the pulpal anesthetic efficacy of lidocaine, articaine, mepivacaine for inferior alveolar nerve block (IANB) in patients with irreversible pulpitis (IP). One hundred and twenty adult patients with IP concerning mandibular molars randomly received IANB with either of the three solutions: 2% lidocaine with epinephrine; 4% articaine with epinephrine; 3% plain mepivacaine. Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Endodontic treatment was initiated. Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation. The anesthetic success rates were analyzed with the chi-square test.

Study Overview

• Status: Completed
• Conditions: Pulpitis
• Intervention / Treatment: Drug: local anaesthetic injection

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• active pain in a mandibular molar
• prolonged response to cold testing with an ice stick and an electric pulp tester
• absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
• vital coronal pulp on access opening and ability to understand the use of pain scales

Exclusion Criteria:

• known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
• history of active peptic ulcer within the preceding 12 months
• history of bleeding problems or anticoagulant use within the last month
• patients who were pregnant or breast-feeding
• a history of known or suspected drug abuse
• patients who had taken NSAIDs within 12 h before administration of the study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inferior Alveolar nerve block with 2% lidocaine with epinephrine; An inferior alveolar nerve block was given with 2% lidocaine with epinephrine	Drug: local anaesthetic injection; Inferior alveolar nerve block
Experimental: Inferior Alveolar nerve block with 4% articaine with epinephrine; An inferior alveolar nerve block was given with 4% articaine with epinephrine	Drug: local anaesthetic injection; Inferior alveolar nerve block
Experimental: Inferior Alveolar nerve block with 3% plain mepivacaine; An inferior alveolar nerve block was given with 3% plain mepivacaine	Drug: local anaesthetic injection; Inferior alveolar nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthetic Success	Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation.	15 minutes after the inferior alveolar nerve block

Collaborators and Investigators

• Sponsor: Dr. Vivek Aggarwal
• Collaborators: SGT DENTAL COLLEGE

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 3, 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 3, 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
• Other Study ID Numbers: SGTTHESIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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