Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Pain Assessment, Quality of Life (QOL), Analgesic Use

In brief

The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.

Key facts

Study ID

NCT06655454

Run by

New York University

People needed

150

Starts

2024-11-01

Expected to finish

2026-12-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medical ASA Class I or II
• Patients above 18 years old
• Patients with a blood pressure below 160/100
• Patients who are treatment planned and have agreed to have emergency endodontic therapy or non-surgical root canal therapy with a pulpal diagnosis of symptomatic irreversible pulpitis according to the AAE Glossary of Endodontic Terms.
• Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English.

You may not qualify if…

• Medical ASA III or above
• Patients who reported the use of tobacco or nicotine-containing products such as vapes, e-cigarettes, gums, or pouches and will not in the 48 hours following treatment
• Patients who reported the use of any marijuana products or illicit drugs in the 48 hours prior to treatment and will not in the next 48 hours.
• Patients who have taken opioids to control pain.
• Pregnant patients
• Patients with a blood pressure of 160/100 or greater
• Patients with a known hypersensitivity or allergy to any local anesthetic agent of the amide group, or any other components of the two anesthetic solutions such as epinephrine, sodium metabisulfite used in the study.
• Patients who have more than one tooth with odontogenic pain at the time of the screening.
• Patients who are unable to consent and do not understand or are unable to read the questionnaires.
• Patients who have had 4 1.7 ml carpules or more of anesthetic (Lidocaine and/ or Septocaine, 1:100,000) during standard care of treatment.

Where it is running

• New York University College of Dentistry — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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