Efficacy of Two Local Anesthetics on Quality of Life After Endodontic Treatment (B-OHIP14)

November 7, 2023 updated by: Asgeir Sigurdsson, DDS, MS, NYU College of Dentistry

Efficacy of Two Dental Local Anesthetics on the Oral Health-Related Quality of Life After Endodontic Treatment in the Symptomatic Mandibular Molars: A Double Blind Randomized Controlled Trial

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 power analysis described in data analysis section as well as general feasibility for recruitment, and the ability to complete the study in within one year.

After screening for eligibility based on the inclusion and exclusion criteria listed below, and after preoperative data collection, in the experimental arm, inferior alveolar nerve block (IANB) will be administered 0.5% bupivacaine with 1:200,000 epinephrine whereas in the control arm, IANB will be administered 2% lidocaine with 1:100,000 epinephrine for a standardized pulpectomy/endodontic debridement treatment as the 1st visit endodontic treatment for subjects with preoperative pain. Postoperative oral health related quality of life questionnaire (OHIP-14) responses at day 1 and 5 as well as 5-day postoperative pain intensity questionnaire will be collected remotely. In this way, we will be able to compare OHQoL change as well as postoperative pain resolution, pain medication use and postoperative soft tissue anesthesia reported by the patient in two study arms.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • NYU College of Dentistry

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
Lidocaine HCI (1.7mL) 2% concentration with epinephrine (1:100,000) is the control agent. It exists in liquid form in cartridges. Lidocaine is a FDA approved marketed anesthetic drug.
Drug: Bupivacaine Local Anesthetic
Long lasting local anesthetic administered to be compared to Lidocaine for quality of life outcomes in dental patients undergoing endodontic treatment
Other Names:
  • Lidocaine Local Anesthetic
Active Comparator: Bupivacaine
Bupivacaine HCI (1.8mL) 5% concentration, with epinephrine (1:200,000) is the investigational product. It exists in liquid form in cartridges. Bupivacaine is a FDA approved marketed anesthetic drug and meets IND Exemption.
Drug: Bupivacaine Local Anesthetic
Long lasting local anesthetic administered to be compared to Lidocaine for quality of life outcomes in dental patients undergoing endodontic treatment
Other Names:
  • Lidocaine Local Anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Bupivacaine/Lidocaine will be assessed on post-operative pain intensity, medication use and length of numbness compared between the two study groups using Oral Health Related Quality-of-Life (OHQoL) questionnaire and Visual Analog Scale (VAS).
Time Frame: 4 weeks +-10 days
The OHQoL questionnaire contains 14 questions and scores can range from 0 to 56. Pain intensity is measured by VAS scale and scores can range from 0-10. Higher scores represent worse outcomes for both assessments.
4 weeks +-10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU College of Dentistry

Investigators

  • Principal Investigator: Asgeir Sigurdsson, NYU Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

July 29, 2019

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s19-00069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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