Effect of Alcohol Consumption on the Success Rates

Not Applicable

Recruiting

• Conditions: Pulpitis - Irreversible
• Interventions: Drug: Lidocaine Hydrochloride

• Registration Number: NCT06201871
• Lead Sponsor: Jamia Millia Islamia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-02
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-03-02
• Study Completion: 2024-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcoholic patients	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.
Control patients	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.

Primary Outcome Measures

Name	Time	Method
Anesthetic success	15 minutes following the injection	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Jamia MIliia Islamia; 🇮🇳 New Delhi, India