Risk of Nerve Damage After Administration of Local Anesthesia

NCT06564987 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CDIOS0005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Outcome Measures

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).

  3 months

Study Arms (2)

Articaine

EXPERIMENTAL

Inferior Alveolar Nerve block using Articaine 4% with 1:200,000 epinephrine local anesthetic

Drug: 4% Articaine with 1:200,000 epinephrine

Lidocaine

ACTIVE COMPARATOR

Inferior Alveolar Nerve block using 2% lidocaine with 1:100,000 epinephrine local anesthetic

Drug: 2% lidocaine with 1:100,000 epinephrine

Interventions

4% Articaine with 1:200,000 epinephrine DRUG

Inferior Alveolar Nerve Block with 4% articaine

Articaine

2% lidocaine with 1:100,000 epinephrine DRUG

Inferior Alveolar Nerve Block with 2% lidocaine

Lidocaine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with age between 18-55 years old
• Patients need IANB
• healthy patient

You may not qualify if:

• medical conditions
• allergies
• medications
• pregnancy and breastfeeding
• inability to provide informed consent
• specific dental or medical history.

Sponsors & Collaborators

• Cleveland Dental Institute: lead

Study Sites (2)

Cleveland Dental Institute

Akron, Ohio, 44703, United States

RECRUITING

Cleveland Dental Institute

Ashtabula, Ohio, 44004, United States

ACTIVE NOT RECRUITING

Related Publications (7)

• Pogrel MA, Thamby S. Permanent nerve involvement resulting from inferior alveolar nerve blocks. J Am Dent Assoc. 2000 Jul;131(7):901-7. doi: 10.14219/jada.archive.2000.0308.

  PMID: 10916328 RESULT

• Mikesell P, Nusstein J, Reader A, Beck M, Weaver J. A comparison of articaine and lidocaine for inferior alveolar nerve blocks. J Endod. 2005 Apr;31(4):265-70. doi: 10.1097/01.don.0000140576.36513.cb.

  PMID: 15793381 RESULT

• Katyal V. The efficacy and safety of articaine versus lignocaine in dental treatments: a meta-analysis. J Dent. 2010 Apr;38(4):307-17. doi: 10.1016/j.jdent.2009.12.003. Epub 2009 Dec 16.

  PMID: 20006669 RESULT

• Stirrup P, Crean S. Does articaine, rather than lidocaine, increase the risk of nerve damage when administered for inferior alveolar nerve blocks in patients undergoing local anaesthesia for dental treatment? A mini systematic review of the literature. Br Dent J. 2019 Feb 8;226(3):213-223. doi: 10.1038/sj.bdj.2019.98.

  PMID: 30734772 RESULT

• Hook H. Inferior alveolar nerve block: is articaine better than lidocaine? Br Dent J. 2021 May;230(9):579-582. doi: 10.1038/s41415-021-2941-z. Epub 2021 May 14.

  PMID: 33990740 RESULT

• Samdrup T, Kijsamanmith K, Vongsavan K, Rirattanapong P, Vongsavan N. The effect of inferior alveolar nerve block anesthesia of 4% articaine and epinephrine 1:100,000 on blood flow and anesthesia of human mandibular teeth. J Dent Sci. 2021 Jan;16(1):249-255. doi: 10.1016/j.jds.2020.05.013. Epub 2020 Jun 4.

  PMID: 33384805 RESULT

• Aquilanti L, Mascitti M, Togni L, Contaldo M, Rappelli G, Santarelli A. A Systematic Review on Nerve-Related Adverse Effects following Mandibular Nerve Block Anesthesia. Int J Environ Res Public Health. 2022 Jan 31;19(3):1627. doi: 10.3390/ijerph19031627.

  PMID: 35162650 RESULT

MeSH Terms

Conditions

Mandibular Nerve Injuries

Interventions

Carticaine; Epinephrine; Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• Ahmed A Hashem, PhD

  Cleveland Dental Institute

  STUDY DIRECTOR

• Waleed Elmallah, PhD

  Cleveland Dental Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo R Velazquez, Resident

CONTACT

7546108595; p.velazquez@cdiohio.org

Nelson A Rendon, Resident

CONTACT

9548605748; n.rendon@cdiohio.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 21, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)