Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

NCT06655454 | Recruiting Phase 2 FDA Drug

• 1 other identifier: i24-01018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Assessment; Quality of Life (QOL); Analgesic Use

Keywords

bupivacaine; nonsurgical endodontic treatment; root canal therapy; irreversible pulpitis; pain management; anesthetic use

Outcome Measures

Primary Outcomes (1)

• Quality of life (scored based on the OHIP-14 questionnaire)

  Quality of life will be measured with a modified version of the OHIP-14 questionnaire. For each question, the answers correspond with a scale that runs from 0-4. A higher score corresponds with a lower quality of life, with 0 being great quality of life and 4 being very poor quality of life.

  Day of operation and daily for four days immediately following endodontic treatment

Secondary Outcomes (2)

• Postoperative pain level

  Day of operation and daily for four days immediately following endodontic treatment

• Analgesic use

  Day of operation and daily for four days immediately following endodontic treatment

Study Arms (3)

Supplemental Postoperative Bupivacaine

EXPERIMENTAL

An additional injection, 1 carpule (1.8 mL) of 0.5% bupivacaine with 1:200,000 epinephrine, will be given to patients in this treatment arm, after their standard endodontic procedure is complete.

Drug: Supplemental Postoperative Bupivacaine

Mock/Placebo Injection

PLACEBO COMPARATOR

If assigned to this arm, the patient will be shown the removal of a needle cap for an anesthetic syringe. The tip will be bent and placed in the patient's mouth, but no tissue penetration will occur. No solution of anesthetic will be delivered.

Drug: Placebo Injection

No Additional Injection

NO INTERVENTION

After standard endodontic procedure, no additional injection will be given.

Interventions

Supplemental Postoperative Bupivacaine DRUG

This is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention.

Supplemental Postoperative Bupivacaine

Placebo Injection DRUG

This intervention will appear to give patients an additional injection, but no additional drug will be given.

Mock/Placebo Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

New York University College of Dentistry

New York, New York, 10010, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lorel E Burns, DDS

CONTACT

212-998-9332; leb409@nyu.edu

NYUSOM IRB

CONTACT

212-263-4110; irb-info@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three types of additional treatment after standard nonsurgical endodontic procedures may be given. These include an additional injection of bupivacaine, an additional mock or placebo injection, and no additional injection.

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)