Effect of Alcohol Consumption on the Success Rates

Jamia Millia Islamia

Status: Enrolling

Conditions: Pulpitis - Irreversible

Treatments: Drug: Lidocaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06201871

IANB

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Alcoholic patients

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine Hydrochloride

Control patients

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine Hydrochloride