RECRUITING

Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

Conditions

Pain Assessment Quality of Life (QOL)Analgesic Use bupivacaine nonsurgical endodontic treatment root canal therapy irreversible pulpitis pain management anesthetic use

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 Title

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

Quick Facts

Study Start:2024-11-01

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06655454

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Lorel E Burns, DDS

CONTACT

212-998-9332

leb409@nyu.edu

NYUSOM IRB

CONTACT

212-263-4110

irb-info@nyulangone.org

Study Locations (Sites)

New York University College of Dentistry

New York, New York, 10010

United States

Collaborators and Investigators

Sponsor: New York University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

bupivacaine
nonsurgical endodontic treatment
root canal therapy
irreversible pulpitis
pain management
anesthetic use

Additional Relevant MeSH Terms

Pain Assessment
Quality of Life (QOL)
Analgesic Use