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Risk of Nerve Damage After Administration of Local Anesthesia

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06564987
Enrollment
80
Registered
2024-08-21
Start date
2024-01-01
Completion date
2025-03-31
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inferior Alveolar Nerve Injuries

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.

Interventions

DRUG4% Articaine with 1:200,000 epinephrine

Inferior Alveolar Nerve Block with 4% articaine

Inferior Alveolar Nerve Block with 2% lidocaine

Sponsors

Cleveland Dental Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Electromyograph3 monthsSigns 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).

Countries

United States

Contacts

Primary ContactPablo R Velazquez, Resident
p.velazquez@cdiohio.org7546108595
Backup ContactNelson A Rendon, Resident
n.rendon@cdiohio.org9548605748

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026