Risk of Nerve Damage After Administration of Local Anesthesia

August 23, 2024 updated by: Cleveland Dental Institute

Risk of Nerve Damage After Administration of an Inferior Alveolar Nerve Block Using 4% Articaine Versus 2% Lidocaine

This research aims to evaluate of the risk of nerve damage following the administration of articaine 4% and lidocaine 2% for Inferior Alveolar nerve Block (IANB). A Randomized Controlled Clinical Trial will be conducted where the patient will be randomly assigned to one the two groups; articaine 4% and Lidocaine 2%. The type of LA will be concealed to the operator, investigators and assessors. The patients will be monitored for any aigns of nerve parathesia for 3 months after the procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44703
        • Recruiting
        • Cleveland Dental Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Pablo Velazquez, resident
        • Sub-Investigator:
          • Nelson Rendon, resident
      • Ashtabula, Ohio, United States, 44004
        • Active, not recruiting
        • Cleveland Dental Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with age between 18-55 years old
  • Patients need IANB
  • healthy patient

Exclusion Criteria:

  • medical conditions
  • allergies
  • medications
  • pregnancy and breastfeeding
  • inability to provide informed consent
  • specific dental or medical history.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Articaine
Inferior Alveolar Nerve block using Articaine 4% with 1:200,000 epinephrine local anesthetic
Drug: 4% Articaine with 1:200,000 epinephrine
Inferior Alveolar Nerve Block with 4% articaine
Active Comparator: Lidocaine
Inferior Alveolar Nerve block using 2% lidocaine with 1:100,000 epinephrine local anesthetic
Drug: 2% lidocaine with 1:100,000 epinephrine
Inferior Alveolar Nerve Block with 2% lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyograph
Time Frame: 3 months
Signs of loss of sensation in the involved side of the jaw will be recorded using a tool called Electromyograph machine to evaluate and record Nerve conduction velocity, the scale is as follow Normal (grade 0) to extremely damage of (grade 6) while a patient rate pain intensity on a Visual Analogue Scale (VAS).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland Dental Institute

Investigators

  • Principal Investigator: Waleed Elmallah, PhD, Cleveland Dental Institute
  • Study Director: Ahmed A Hashem, PhD, Cleveland Dental Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDIOS0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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