Effect of Alcohol Consumption on the Success Rates

Effect of Alcohol Consumption on the Success Rates of Local Anesthesia in Patients With Symptomatic Irreversible Pulpitis

This prospective, randomized, double-blind clinical trial will be carried out Conservative Dentistry, Faculty of Dentistry, Jamia Millia Islamia. Seventy adult patients (35 alcoholic and 35 non-alcoholics) with symptomatic irreversible pulpits in a mandibular first or second molar will receive an IANB with 2% lidocaine. In case of pain during treatment, the procedure will be stopped, and the patients will be asked to rate the pain on the Heft-Parker scale. The injection shall be considered as successful if the patient reports pain scores less than 55 on the HP scale.

Study Overview

• Status: Completed
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Drug: Lidocaine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • New Delhi
    • New Delhi, New Delhi, India, 110025
      • Faculty of Dentistry, Jamia MIliia Islamia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Symptomatic carious exposed mandibular first or second molars.
• Alcoholic patients: Patient with low-moderate drinking levels according to the US National Institute on Alcohol Abuse and Alcoholism
• Control patients: No history of alcohol consumption
• Positive and prolonged response to thermal sensitivity tests and electric pulp test.
• Vital coronal pulp on access cavity preparation.
• American Society of Anesthesiologists class I or II medical history.
• Ability to understand the use of pain scales.

Exclusion Criteria:

• Active pain in more than 1 teeth
• Teeth with fused roots.
• Radiographic evidence of an extra root.
• Large restorations with overhanging margins.
• Full crowns or deep periodontal pockets.
• Hypertension or cardiovascular diseases, compromised immunity, active infection or inflammation
• Known allergy or contraindications to any content of the local anesthetic solution or non-steroidal anti-inflammatory drugs (NSAIDs)
• History of known or suspected drug abuse.
• Taking any drugs which could affect the pain perception, e.g, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, nsaids. 23
• Pregnant or breastfeeding patients.
• Patients with asthma, gastric ulcers, bleeding disorders.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcoholic patients; Patients will receive an inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach.	Drug: Lidocaine Hydrochloride; Patients will receive an inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach.
Active Comparator: Control patients; Patients will receive an inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach.	Drug: Lidocaine Hydrochloride; Patients will receive an inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthetic success	The injection shall be considered as successful if the patient reports pain scores less than 55 on the visual analouge scale. The scale is 170mm long, with 0 marked as no pain and 170 marked as the maximum pain.	15 minutes following the injection

Collaborators and Investigators

• Sponsor: Jamia Millia Islamia

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): August 14, 2024
• Study Completion (Actual): August 14, 2024

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Alcohol Drinking; Pulpitis; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine
• Other Study ID Numbers: IANB

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
• product manufactured in and exported from the U.S.: No