Recruiting

NCT Number: NCT06564987

Risk of Nerve Damage After Administration of Local Anesthesia

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.

Recruiting

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Key information

Conditions

Inferior Alveolar Nerve Injuries Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Facial Nerve Diseases Facial Neuralgia Mandibular Nerve Injuries Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trauma, Nervous System Trigeminal Nerve Diseases Trigeminal Nerve Injuries Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cleveland Dental Institute, Akron, Ohio, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

Electromyograph

Time frame: 3 months

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Nelson A Rendon, Resident

CONTACT

[email protected]

9548605748

Pablo R Velazquez, Resident

CONTACT

[email protected]

7546108595

Sponsors and collaborators

Lead sponsor

Cleveland Dental Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Aug 21, 2024
Registry last updated: Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed