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Local Anesthetic

Local Anesthesia for Nerve Damage

Phase 1
Recruiting
Led By Waleed Elmallah, PhD
Research Sponsored by Cleveland Dental Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with age between 18-55 years old
Be between 18 and 65 years old
Must not have
Inability to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the risk of nerve damage after receiving two different types of numbing medications for a dental procedure. Patients will be randomly assigned to receive either articaine 4% or lidocaine

Who is the study for?
This trial is for individuals who require an Inferior Alveolar nerve Block (IANB) and are at risk of mandibular or inferior alveolar nerve injury. Specific eligibility criteria details are not provided, but typically include adults in good health without conflicting medical conditions.
What is being tested?
The study compares the risk of nerve damage after using two types of local anesthesia: Articaine (4% with 1:200,000 epinephrine) versus Lidocaine (2% with 1:100,000 epinephrine). It's a blind test where neither patients nor doctors know which drug is used.
What are the potential side effects?
Potential side effects may include temporary numbness, tingling or prickling sensations (paresthesia), pain at the injection site, or more rarely persistent nerve damage leading to chronic numbness or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ArticaineExperimental Treatment1 Intervention
Inferior Alveolar Nerve block using Articaine 4% with 1:200,000 epinephrine local anesthetic
Group II: LidocaineActive Control1 Intervention
Inferior Alveolar Nerve block using 2% lidocaine with 1:100,000 epinephrine local anesthetic

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cleveland Dental InstituteLead Sponsor
5 Previous Clinical Trials
362 Total Patients Enrolled
Ahmed A Hashem, PhDStudy DirectorCleveland Dental Institute
1 Previous Clinical Trials
84 Total Patients Enrolled
Waleed Elmallah, PhDPrincipal InvestigatorCleveland Dental Institute
1 Previous Clinical Trials
108 Total Patients Enrolled
~7 spots leftby Dec 2024
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