Clinical trial NCT06564987: Risk of Nerve Damage After Administration of Local Anesthesia
Official title: Risk of Nerve Damage After Administration of an Inferior Alveolar Nerve Block Using 4% Articaine Versus 2% Lidocaine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Inferior Alveolar Nerve Injuries
Lead sponsor: Cleveland Dental Institute
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Electromyograph
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Cleveland Dental Institute
state: Ohio
city: Ashtabula
country: United States
facility: Cleveland Dental Institute
state: Ohio
Study officials:
affiliation: Cleveland Dental Institute
name: Ahmed A Hashem, PhD
role: STUDY_DIRECTOR
affiliation: Cleveland Dental Institute
name: Waleed Elmallah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.