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Risk of Nerve Damage After Administration of Local Anesthesia

C

Cleveland Dental Institute

Status and phase

Enrolling
Phase 1

Conditions

Inferior Alveolar Nerve Injuries

Treatments

Drug: 4% Articaine with 1:200,000 epinephrine
Drug: 2% lidocaine with 1:100,000 epinephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT06564987
CDIOS0005

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups

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

Trial contacts and locations

2

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Central trial contact

Pablo R Velazquez, Resident; Nelson A Rendon, Resident

Data sourced from clinicaltrials.gov

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