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

NCT05227300 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-14

Study results available
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Summary

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.

Conditions

  • Symptomatic Irreversible Pulpitis

Interventions

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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

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
2022-02-14
Primary Completion
2022-05-23
Completion
2022-06-30
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 NCT05227300 on ClinicalTrials.gov