Recruiting
Phase 2

Long-Acting Anesthetic

Sponsor:

New York University

Code:

NCT06655454

Conditions

Pain Assessment

Quality of Life (QOL)

Analgesic Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Supplemental Postoperative Bupivacaine

Placebo Injection

Study Details

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

Study ID

NCT06655454

Start date

Nov 1, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Medical ASA Class I or II
2. Patients above 18 years old
3. Patients with a blood pressure below 160/100
4. 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.
5. Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English.

Exclusion Criteria:

1. Medical ASA III or above
2. 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
3. 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.
4. Patients who have taken opioids to control pain.
5. Pregnant patients
6. Patients with a blood pressure of 160/100 or greater
7. 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.
8. Patients who have more than one tooth with odontogenic pain at the time of the screening.
9. Patients who are unable to consent and do not understand or are unable to read the questionnaires.
10. 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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supplemental Postoperative Bupivacaine

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.

placebo comparator: Mock/Placebo Injection

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.

no intervention: No Additional Injection

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

Interventions

Supplemental Postoperative Bupivacaine

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

Placebo Injection

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

Primary outcome measure

  • Quality of life (scored based on the OHIP-14 questionnaire) [ Time Frame: Day of operation and daily for four days immediately following endodontic treatment ]

Central Contacts and Locations

Central contacts

Lorel E Burns, DDS

212-998-9332leb409@nyu.edu

NYUSOM IRB

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

Locations

New York University College of Dentistry

Recruiting

New York, New York, United States, 10010

Contacts

Lorel E Burns, DDS, MS

212-998-9332leb409@nyu.edu

Principal Investigator:

Lorel E Burns, DDS

More Information

Sponsor

New York University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2026-04-13.