Combination of Buffered Anesthetic to Treat Mandibular Molars

May 12, 2025 updated by: Kenneth J. Spolnik DDS, Indiana University

Buffered vs Unbuffered Local Anesthesia Using Lidocaine, Carbocaine, and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis

The purpose of this study is to determine whether a combination of anesthetics (numbing medicine) will adequately anesthetize teeth over a different combination. 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

Terminated

Conditions

Intervention / Treatment

Detailed Description

60 human subjects with Symptomatic Irreversible Pulpitis (SIP) in mandibular molars will be randomly allocated into 2 groups. One group will receive a combination of: 1 cartridge of buffered 2% lidocaine w/ 1:100k epi via inferior alveolar nerve block (IANB) followed by 1 cartridge of 3% mepivacaine via IANB. This will be followed by 0.5 cartridges (0.9mL) of buffered 4% articaine with 1:100k epi via buccal infiltration and 0.5 cartridges of buffered 4% articaine with 1:100k epi via lingual infiltration. All IANB injections will include a lingual block. The second group will be provided an unbuffered version of the same combination. An electronic pulp tester (EPT) will be used to determine the vitality of the treated tooth. Endodontic treatment will be initiated after two consecutive EPT readings of 80, displaying pulpal anesthesia. Profound pulpal anesthesia is described by the patient's report on the visual analog scale after the pulpotomy.

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
        • ndiana 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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:

  • 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
Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
Drug: Sodium bicarbonate
Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
Other Names:
  • Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solutio
Drug: Lidocaine w/ epi
Septodont's standard formulation of 2% lidocaine with epinephrine
Other Names:
  • 2% lidocaine with 1:100,000 epinephrine
Drug: Articaine w/ epi
Septodont's standard formulation of 4% articaine with epinephrine
Other Names:
  • 4% articaine with 1:100,000 epinephrine
Drug: Mepivacaine plain
Septodont's standard formulation of 3% mepivacaine
Other Names:
  • 3% Mepivacaine
Active Comparator: Unbuffered
Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics
Drug: Lidocaine w/ epi
Septodont's standard formulation of 2% lidocaine with epinephrine
Other Names:
  • 2% lidocaine with 1:100,000 epinephrine
Drug: Articaine w/ epi
Septodont's standard formulation of 4% articaine with epinephrine
Other Names:
  • 4% articaine with 1:100,000 epinephrine
Drug: Mepivacaine plain
Septodont's standard formulation of 3% mepivacaine
Other Names:
  • 3% Mepivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Visual Analogue Scale (VAS) Score as a Measure of Profoundness of Pulpal Anesthesia
Time Frame: Up to 20 minutes post-drug administration
Patient will report their comfort during treatment based on a visual analogue scale (VAS) graphic. Visual analog scale (VAS) is based on a scale of 0-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment indicating there was inadequate anesthesia. A VAS score of 0 indicates no pain.
Up to 20 minutes post-drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Time to Profound Pulpal Anesthesia
Time Frame: Up to 15 minutes post-drug administration
An electronic pulp tester will be used to assess anesthesia after anesthetic is administered. The median time needed to achieve profound pulpal anesthesia for the two groups will be calculated using the Kaplan-Meier method and compared with a log-rank test, with patients who failed to achieve profound pulpal anesthesia censored at 15 minutes.
Up to 15 minutes post-drug administration

Collaborators and Investigators

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

Sponsor

Indiana University

Investigators

  • Study Chair: Kenneth Spolnik, DDS, Program Director

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)

December 5, 2023

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17799

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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