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Local Anesthetic

Post-Operative Anesthetics for Root Canal Pain

Phase 4

Waitlist Available

Led By Courtney Lang, BS, DDS

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

>18 years old

Diagnosis of symptomatic irreversible pulpitis on mandibular, posterior tooth

Must not have

Patients who are contraindicated to take ibuprofen

Diagnosis of pulp necrosis or reversible pulpitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will be asked to track total analgesic use 72 hours post-operatively, and to record times and amounts of use during the 72 hour window in which they are recording their pain levels.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests 2 numbing drugs to reduce pain after root canal treatment.

Who is the study for?

This trial is for adults over 18 with a specific tooth condition called symptomatic irreversible pulpitis in a back lower tooth. They should be generally healthy (ASA I or II). It's not for those allergic to the study drugs, can't take ibuprofen, have dead or less severe tooth nerve conditions, are under 18, very sick (ASA III-V), or have teeth that can't be fixed.

What is being tested?

The study is testing two local anesthetics: one with lidocaine and another with bupivacaine, both containing epinephrine. The goal is to see which one better reduces pain after root canal treatments in affected patients.

What are the potential side effects?

Local anesthetics like lidocaine and bupivacaine may cause side effects such as numbness beyond the targeted area, slight bruising where injected, rare allergic reactions, or temporary difficulty swallowing.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 years old.

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I have severe tooth pain in the back of my lower jaw that can't be fixed.

Exclusion Criteria

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

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I cannot take ibuprofen due to health reasons.

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I have been diagnosed with a dead or inflamed tooth nerve.

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My dentist says my tooth cannot be fixed.

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My health is severely impacted by my disease.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will be asked to track total analgesic use 72 hours post-operatively, and to record times and amounts of use during the 72 hour window in which they are recording their pain levels.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will be asked to track total analgesic use 72 hours post-operatively, and to record times and amounts of use during the 72 hour window in which they are recording their pain levels.

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be asked to track total analgesic use 72 hours post-operatively, and to record times and amounts of use during the 72 hour window in which they are recording their pain levels. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Post-operative pain level 12 hours on a visual analog scale

Post-operative pain level 24 hours on a visual analog scale

Post-operative pain level 48 hours on a visual analog scale

+2 more

Secondary study objectives

Over the counter analgesic use

Awards & Highlights

Drug Has Already Been Approved

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

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Active Control

Group I: 2% Lidocaine 1:100,000 epinephrineActive Control1 Intervention

Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 2% Lidocaine 1:100,000 epinephrine following endodontic treatment.

Group II: 0.5% bupivicaine 1:200,000 epinephrineActive Control1 Intervention

Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment.

0 / 7Eligibility criteria met