Effect of Alcohol Consumption on the Success Rates

NCT ID: NCT06201871

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2024-03-02

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.

Conditions

Pulpitis - Irreversible

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidocaine Hydrochloride

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine Hydrochloride

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jamia Millia Islamia

OTHER

Sponsor Role: lead

Responsible Party

Dr. Vivek Aggarwal

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, , India

Site Status: RECRUITING

Countries

India

Central Contacts

Vivek Aggarwal

Role: CONTACT

drvivekaggarwal@gmail.com

9818188358

Facility Contacts

Vivek Aggarwal, MDS

Role: primary

drvivekaggarwal@gmail.com

01126981818

Other Identifiers

IANB

Identifier Type: -

Identifier Source: org_study_id