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

Primary Purpose

Pain, Postoperative, Quality of Life

Status

Suspended

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine Local Anesthetic

About this trial

This is an interventional health services research trial for Pain, Postoperative

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

NYU College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Lidocaine

Bupivacaine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04787731

First Posted

March 4, 2021

Last Updated

October 5, 2022

Sponsor

NYU College of Dentistry

1. Study Identification

Unique Protocol Identification Number

NCT04787731

Brief Title

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

Acronym

B-OHIP14

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Suspended

Why Stopped

COVID-19 and Personnel changes

Study Start Date

July 29, 2019 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

NYU College of Dentistry

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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/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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Quality of Life

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Double blind randomized clinical trial

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Bupivacaine

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Local Anesthetic

Other Intervention Name(s)

Lidocaine Local Anesthetic

Intervention Description

Long lasting local anesthetic administered to be compared to Lidocaine for quality of life outcomes in dental patients undergoing endodontic treatment

Primary Outcome Measure Information:

Title

Description

Time Frame

4 weeks +-10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asgeir Sigurdsson

Organizational Affiliation

NYU Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU College of Dentistry

City

New York

State/Province

New York

ZIP/Postal Code

10010

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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