Phase 2: testing Supplemental Postoperative Bupivacaine for Pain Assessment
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.
Official registry: https://clinicaltrials.gov/study/NCT06655454 · New York University · enrollment listed as 150
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Supplemental Postoperative Bupivacaine, or Placebo Injection. The registry lists allocation as randomized. 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.
They plan to enroll about 150 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
The Effects of Supplemental Postoperative 0.5% Bupivacaine With 1:200,000 Epinephrine Following Non-Surgical Endodontic Treatment on Patients' Quality of Life, Pain, and Analgesic Consumption
Interventions: Supplemental Postoperative Bupivacaine, Placebo Injection
Primary outcome (registry wording): Quality of life (scored based on the OHIP-14 questionnaire)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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
- 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
Public study contact (from the registry)
Lorel E Burns, DDS
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- New York University College of Dentistry — New York, New York (recruiting)
FAQ about this NCT record
Is NCT06655454 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06655454?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06655454?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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