Extra pain relief after root canal treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of an additional injection of long-acting bupivacaine on pain levels, quality of life, and analgesic use following nonsurgical endodontic treatment for symptomatic irreversible pulpitis. Participants will be divided into three groups: one receiving bupivacaine, one receiving a placebo injection, and one receiving no additional anesthetic. The study aims to determine if the supplemental anesthetic significantly reduces pain and improves recovery outcomes compared to the other groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• New York University College of Dentistry
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Lorel E Burns, DDS
• Email: leb409@nyu.edu
• Phone: 212-998-9332

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.