Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis

April 18, 2024 updated by: Kenneth J. Spolnik DDS, Indiana University

Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Controlled, Randomized Double-blind Study

The purpose of this study is to determine whether one type of anesthetic (numbing medicine) will work better at numbing the nerve in a tooth than using a different type of anesthetic. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

40 subjects with a mandibular molar diagnosed with symptomatic irreversible pulpitis will be randomly allocated into 2 groups. One group will receive a total of 3 cartridges of a standard, unbuffered 2% lidocaine with 1:100,000 epinephrine via inferior alveolar nerve block (IANB) followed by supplemental buccal and lingual infiltrations, while the other will receive the equivalent yet buffered formulation. An electronic pulp tester (EPT) will be used to objectively determine baseline pulpal status of the affected tooth, followed by 2-minute interval testing following the administration of all local anesthesia. The onset of pulpal anesthesia is defined by the first of 2 consecutive EPT=80 readings, and the endodontic treatment may begin. Profound pulpal anesthesia is ultimately determined if the patients report a comfortable pulpotomy as reflected on the Wong-Baker FACES Visual Analog Scale.

Study Type

Interventional

Enrollment (Actual)

40

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
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Dentistry Graduate Endodontics Dept.

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria - In order to participate, subjects must:

  • Be between the ages of 18 and 80 years old
  • Have the ability and willingness to independently consent to treatment and study participation
  • Have an uncomplicated medical history (ASA I and II)
  • Not be pregnant
  • Have no allergies local anesthetics/sulfites (confirmed or self-reported)
  • Not be taking any medications that may affect the proper assessment of the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 6 hours; no long-acting NSAIDs such as naproxen within the previous 16 hours)
  • Not require nitrous oxide during treatment, and the injection area should appear healthy with no other pre-existing conditions or infections that may compromise an accurate collection of data
  • Be experiencing signs of irreversible pulpitis (an exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the time of conducting the study

Exclusion Criteria - No subjects will have:

  • A negative response to cold in the proposed treatment tooth
  • A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buffered 2% lidocaine with 1:100,000 epinephrine
Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
Drug: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution
Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
Drug: 2% lidocaine with 1:100,000 epinephrine
Septodont's standard formulation of 2% lidocaine with epinephrine
Active Comparator: Unbuffered 2% lidocaine with 1:100,000 epinephrine
Standard local anesthetic
Drug: 2% lidocaine with 1:100,000 epinephrine
Septodont's standard formulation of 2% lidocaine with epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Scores as Measures of Profoundness of Pulpal Anesthesia
Time Frame: Up to 20 minutes post-drug administration
The mean Visual Analog Scale (VAS) score, which ranges from a min of 1 to a max of 10. In other words, inadequate anesthesia is considered to be a VAS score that is between 4 and 10 because that is not considered to be "comfortable and profound".
Up to 20 minutes post-drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of Pulpal Anesthesia
Time Frame: Up to 20 minutes post-drug administration
Duration of time in minutes required to achieve pulpal anesthesia, defined as an electrical pulp test score of 80 (which is the maximum stimulation). Any EPT score between 1-79 after 20 minutes post-anesthesia is considered a failure of pulpal anesthesia.
Up to 20 minutes post-drug administration

Collaborators and Investigators

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

Sponsor

Indiana University

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)

February 14, 2022

Primary Completion (Actual)

May 23, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11447

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.

Yes

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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