Recruiting
Phase 1

Local Anesthesia

Sponsor:

Cleveland Dental Institute

Code:

NCT06564987

Conditions

Inferior Alveolar Nerve Injuries

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

4% Articaine with 1:200,000 epinephrine

2% lidocaine with 1:100,000 epinephrine

Study Details

Brief summary:

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.

Conditions

Inferior Alveolar Nerve Injuries

Study ID

NCT06564987

Start date

Jan 1, 2024

Status verified date

Jul, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

4% Articaine with 1:200,000 epinephrine

Inferior Alveolar Nerve Block with 4% articaine

2% lidocaine with 1:100,000 epinephrine

Inferior Alveolar Nerve Block with 2% lidocaine

Primary outcome measure

  • Electromyograph [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Pablo R Velazquez, Resident

7546108595p.velazquez@cdiohio.org

Nelson A Rendon, Resident

9548605748n.rendon@cdiohio.org

Locations

Cleveland Dental Institute

Recruiting

Akron, Ohio, United States, 44703

Contacts

Waleed Elmallah, PhD

216-333-6695w.elmallah@cdiohio.org

Ahmed A Hashem, PhD

4405021591a.hashem@cdiohio.org

More Information

Sponsor

Cleveland Dental Institute

Last update posted

Aug 26, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cleveland Dental Institute on 2024-08-26.