Risk of Nerve Damage After Administration of Local Anesthesia

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCleveland Dental Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with age between 18-55 years old

Patients need IANB

healthy patient

Disqualifiers

medical conditions

allergies

medications

pregnancy and breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ArticaineExperimental treatment 1 intervention
Group B: LidocaineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Electromyograph

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).

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.