Risk of Nerve Damage After Administration of Local Anesthesia
NCT ID: NCT06564987
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2024-01-01
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Articaine
Inferior Alveolar Nerve block using Articaine 4% with 1:200,000 epinephrine local anesthetic
4% Articaine with 1:200,000 epinephrine
Inferior Alveolar Nerve Block with 4% articaine
Lidocaine
Inferior Alveolar Nerve block using 2% lidocaine with 1:100,000 epinephrine local anesthetic
2% lidocaine with 1:100,000 epinephrine
Inferior Alveolar Nerve Block with 2% lidocaine
Interventions
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4% Articaine with 1:200,000 epinephrine
Inferior Alveolar Nerve Block with 4% articaine
2% lidocaine with 1:100,000 epinephrine
Inferior Alveolar Nerve Block with 2% lidocaine
Eligibility Criteria
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Inclusion Criteria
* Patients need IANB
* healthy patient
Exclusion Criteria
* allergies
* medications
* pregnancy and breastfeeding
* inability to provide informed consent
* specific dental or medical history.
18 Years
55 Years
ALL
Yes
Sponsors
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Cleveland Dental Institute
OTHER
Responsible Party
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Principal Investigators
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Ahmed A Hashem, PhD
Role: STUDY_DIRECTOR
Cleveland Dental Institute
Waleed Elmallah, PhD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Dental Institute
Locations
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Cleveland Dental Institute
Akron, Ohio, United States
Cleveland Dental Institute
Ashtabula, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CDIOS0005
Identifier Type: -
Identifier Source: org_study_id
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