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Local Anesthetic
Post-Operative Anesthetics for Root Canal Pain
Phase 4
Recruiting
Led By Jordan Johnson
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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 18 years old.
Select...
I have severe tooth pain in the back of my lower jaw that can't be fixed.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Over the counter analgesic use
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.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,739 Previous Clinical Trials
1,847,888 Total Patients Enrolled
1 Trials studying Postoperative Pain
800 Patients Enrolled for Postoperative Pain
Jordan JohnsonPrincipal InvestigatorUniversity of Washington
Courtney Lang, BS, DDSPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.You have a low or moderate risk of surgical complications.I cannot take ibuprofen due to health reasons.I have been diagnosed with a dead or inflamed tooth nerve.My dentist says my tooth cannot be fixed.My health is severely impacted by my disease.I have severe tooth pain in the back of my lower jaw that can't be fixed.I have an issue with a front tooth in my upper or lower jaw.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: 2% Lidocaine 1:100,000 epinephrine
- Group 2: 0.5% bupivicaine 1:200,000 epinephrine
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential harms could arise from the use of 2% Lidocaine 1:100,000 epinephrine?
"After a thorough assessment, we have determined that 2% Lidocaine 1:100,000 epinephrine is safe to use and has been approved by authorities; thus receiving the highest score of 3."
Answered by AI
Are recruitments currently taking place for this clinical trial?
"The registration on clinicaltrials.gov states that this medical experiment is no longer recruiting participants, as it was last edited on August 27th 2023 after being initially posted nearly two years ago. Fortunately, there are currently 552 other active clinical trials seeking volunteers."
Answered by AI
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