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Combination of Buffered Anesthetic to Treat Mandibular Molars

NCT06047366 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-13

Study results available
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Summary

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.

Conditions

  • Symptomatic Irreversible Pulpitis

Interventions

DRUG

Sodium bicarbonate

Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic

DRUG

Lidocaine w/ epi

Septodont's standard formulation of 2% lidocaine with epinephrine

DRUG

Articaine w/ epi

Septodont's standard formulation of 4% articaine with epinephrine

DRUG

Mepivacaine plain

Septodont's standard formulation of 3% mepivacaine

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Kenneth Spolnik, DDS · Program Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2024-05-15
Completion
2024-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06047366 on ClinicalTrials.gov