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Local Anesthetic

Buffered Anesthetic for Toothache

Phase 4

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between the ages of 18 and 80 years old

Have the ability and willingness to independently consent to treatment and study participation

Must not have

A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 20 minutes post-drug administration

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial compares two anesthetics to see which one numbs teeth faster and better.

Who is the study for?

This trial is for adults aged 18-80 with a toothache from irreversible pulpitis in a lower back tooth, who are generally healthy and not pregnant. Participants must not have allergies to local anesthetics or be on certain painkillers that could affect the study.

What is being tested?

The study tests if combining different numbing medicines (Articaine, Mepivacaine, Lidocaine with Sodium bicarbonate) works better for dental pain than using them separately. It also looks at how quickly they numb the affected nerve.

What are the potential side effects?

Possible side effects include temporary numbness beyond the targeted area, mild discomfort at injection site, allergic reactions to components of the anesthetic solution, and rare cases of prolonged numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I can and agree to make my own decisions about treatment and study participation.

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I have lasting tooth pain in a lower back tooth when it's exposed to cold.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe tooth root infection or swelling inside my mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 20 minutes post-drug administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 20 minutes post-drug administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 minutes post-drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual analogue scale (VAS) Scores as Measures of Profoundness of Pulpal Anesthesia

Secondary study objectives

Onset of Pulpal Anesthesia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BufferedExperimental Treatment4 Interventions

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)

Group II: UnbufferedActive Control3 Interventions

Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium bicarbonate

2012

Completed Phase 4

~3680

0 / 4Eligibility criteria met