Risk of Nerve Damage After Administration of Local Anesthesia

Part of paid clinical trials in Akron, Ohio.

Sponsor
Cleveland Dental Institute
Study ID
NCT06564987
Phase
PHASE1
Status
Recruiting

Conditions

  • Inferior Alveolar Nerve Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 4% Articaine with 1:200,000 epinephrine — DRUG
    Inferior Alveolar Nerve Block with 4% articaine
  • 2% lidocaine with 1:100,000 epinephrine — DRUG
    Inferior Alveolar Nerve Block with 2% lidocaine

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Articaine
    Inferior Alveolar Nerve block using Articaine 4% with 1:200,000 epinephrine local anesthetic
  • Active Comparator: Lidocaine
    Inferior Alveolar Nerve block using 2% lidocaine with 1:100,000 epinephrine local anesthetic

Primary Outcome Measure

Electromyograph [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cleveland Dental InstituteAkronOhio44703
Waleed Elmallah, PhD
216-333-6695
Ahmed A Hashem, PhD
4405021591
Pablo Velazquez, resident (SUB_INVESTIGATOR)
Nelson Rendon, resident (SUB_INVESTIGATOR)
Cleveland Dental InstituteAshtabulaOhio44004-

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