New treatment option for Pain Assessment
Official title Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment
ClinicalTrials.gov ID: NCT06655454
What this study is testing
What is Supplemental Postoperative Bupivacaine?
Supplemental Postoperative Bupivacaine is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pain assessment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English.
You likely can't join 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...
- 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
See the full eligibility criteria
- 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...
- Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.