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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 20 minutes post-drug administration

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Onset of Pulpal Anesthesia

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,101 Total Patients Enrolled

Kenneth Spolnik, DDSStudy ChairProgram Director

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the use of Buffered associated with any health risks?

"Buffered has received a score of 3, signifying its high level of safety due to it having reached the approval stage in clinical trials."

Answered by AI

Are senior citizens being admitted into this research trial?

"The requirement for participation in this research is that the patient is aged between 18 and 80 years. For those outside of this age bracket, 17 clinical trials are available to minors and 12 studies addressing individuals over 65."

Answered by AI

Are participants being recruited for this clinical trial at present?

"The information available on clinicaltrials.gov reveals that this specific trial is no longer searching for participants, since its last update was posted on September 14th 2023. Despite the inactivity of this study, there are 31 other trials actively recruiting at present."

Answered by AI

Am I eligible to participate in this clinical trial?

"Eligibility criteria for this medical trial includes a diagnosis of irreversible pulpitis and an age range between 18 to 80 years old. A total of 60 individuals can partake in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination of Buffered Anesthetic to Treat Mandibular Molars

Kenneth J. Spolnik DDS 2023. "Combination of Buffered Anesthetic to Treat Mandibular Molars". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047366.

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