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OpenTrials
Completed

NCT Number: NCT06201871

Effect of Alcohol Consumption on the Success Rates

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.

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Key information

Conditions

Pulpitis - Irreversible

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, 110025, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine Hydrochloride

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.

Primary outcomes

  1. Anesthetic success

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jamia Millia Islamia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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