Status:
SUSPENDED
Efficacy of Two Local Anesthetics on Quality of Life After Endodontic Treatment
Lead Sponsor:
NYU College of Dentistry
Conditions:
Pain, Postoperative
Quality of Life
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
This is a double-blind randomized controlled single-site trial. We aim to recruit 100 subject, with an anticipated dropout rate of 20%; our goal is to enroll 40 subjects in each study arm based on the...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04787731
Start Date
July 29 2019
End Date
October 1 2024
Last Update
November 8 2023
Active Locations (1)
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1
NYU College of Dentistry
New York, New York, United States, 10010