CompletedNot Applicable

Effect of Alcohol Consumption on the Success Rates

India236 participantsStarted 2024-01-02

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anesthetic success

Timeframe: 15 minutes following the injection

Trial details

NCT IDNCT06201871

SponsorJamia Millia Islamia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-14

View on ClinicalTrials.gov More Pulpitis - Irreversible trials