Effect of Alcohol Consumption on the Success Rates

Pulpitis - Irreversible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201871
• Other study ID #: IANB
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: March 2, 2024

Study information

• Verified date: January 2024
• Source: Jamia Millia Islamia
• Contact: Vivek Aggarwal
• Phone: 9818188358
• Email: drvivekaggarwal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Pulpitis
• Pulpitis - Irreversible

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
India	Faculty of Dentistry, Jamia MIliia Islamia	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Jamia Millia Islamia

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthetic success	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.	15 minutes following the injection