Efficacy of Two Local Anesthetics on Quality of Life After Endodontic Treatment

Paused · Phase 4

Conditions studied: Pain, Postoperative, Quality of Life

In brief

In this randomized controlled double-blinded study, subjects will be assigned to one of two study groups to either be anesthetized with Bupivacaine or Lidocaine prior to needed treatment of pulpectomy/endodontic debridement on a symptomatic tooth. Subjects' oral health related quality of life and postoperative pain resolution, pain medication use and numbness will be compared in two study groups.

Key facts

Study ID

NCT04787731

Run by

NYU College of Dentistry

People needed

100

Starts

2019-07-29

Expected to finish

2024-10-01

Last updated by the study team

2023-11-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients between the ages of 18-85 years
• Patients with pulpal diagnosis of either symptomatic irreversible pulpitis or pulp necrosis and periapical diagnosis of normal apical tissues, symptomatic apical periodontitis or asymptomatic apical periodontitis.
• Patients who only have one tooth with odontogenic pain at the time point of the screening.
• Patients who are treatment planned, and have agreed to have, pulpectomy/endodontic debridement.
• Patients with acute dental pain of at least 3/10 on NRS
• Patients must be able to comprehend and complete all study questionnaires
• Patients must be able to comprehend the description of the study protocol and written consent Patients must be able to be contacted by text messages, phone calls or email during 5 days after pulpectomy/endodontic debridement

You may not qualify if…

• Medically complex patients with severe systemic diseases (ASA III or above). These may include uncontrolled diabetes, uncontrolled blood pressure and/or chronic renal failure, for example, and potential participants will be asked about these conditions during the screening process.
• Pregnant Patients
• Patients who have already been enrolled in the study. Patients can only be enrolled for treatment on one tooth.
• Patients with 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 use ergot-type oxytocic drugs for uterine contraction, monoamine oxidase inhibitors, antidepressant of triptyline or imipramine types or patients who are planned to receive sedatives for the treatment.
• Patients with additional elective dental treatments like extraction, implant placement, root canal therapy planned in the 5 days following the date of enrollment in this study
• Patients with pain whose examined tooth is planned for vital pulp therapies e.g. pulpotomy, retreatment, apical surgery or extraction
• Patients with a pulpal diagnosis or reversible pulpitis, previously treated, previously initiated therapy and periapical diagnosis of acute apical abscess or chronic apical abscess.
• Patients who have multiple teeth with odontogenic pain at the time of the screening
• Patients who do not understand or are able to read the questionnaires
• Non-English speaking patients

Where it is running

• NYU College of Dentistry — New York, New York, United States

Full record on ClinicalTrials.gov

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