NCT06655454 Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment
| NCT ID | NCT06655454 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | New York University |
| Condition | Pain Assessment |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2024-11-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06655454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain Assessment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06655454 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06655454 currently recruiting?
Yes, NCT06655454 is actively recruiting participants. Contact the research team at leb409@nyu.edu for enrollment information.
Where is the NCT06655454 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06655454 clinical trial?
NCT06655454 is sponsored by New York University. The trial plans to enroll 150 participants.