Risk of Nerve Damage After Administration of Local Anesthesia

NCT ID: NCT06564987

Last Updated: 2024-08-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inferior Alveolar Nerve Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Articaine

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

Group Type EXPERIMENTAL

4% Articaine with 1:200,000 epinephrine

Intervention Type DRUG

Inferior Alveolar Nerve Block with 4% articaine

Lidocaine

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

Group Type ACTIVE_COMPARATOR

2% lidocaine with 1:100,000 epinephrine

Intervention Type DRUG

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

Intervention Type DRUG

2% lidocaine with 1:100,000 epinephrine

Inferior Alveolar Nerve Block with 2% lidocaine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cleveland Dental Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Cleveland Dental Institute

Ashtabula, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Pablo R Velazquez, Resident

Role: CONTACT

7546108595

Nelson A Rendon, Resident

Role: CONTACT

9548605748

Facility Contacts

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Waleed Elmallah, PhD

Role: primary

216-333-6695

Ahmed A Hashem, PhD

Role: backup

4405021591

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.

Reference Type RESULT
PMID: 10916328 (View on PubMed)

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.

Reference Type RESULT
PMID: 15793381 (View on PubMed)

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.

Reference Type RESULT
PMID: 20006669 (View on PubMed)

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.

Reference Type RESULT
PMID: 30734772 (View on PubMed)

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.

Reference Type RESULT
PMID: 33990740 (View on PubMed)

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.

Reference Type RESULT
PMID: 33384805 (View on PubMed)

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.

Reference Type RESULT
PMID: 35162650 (View on PubMed)

Other Identifiers

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CDIOS0005

Identifier Type: -

Identifier Source: org_study_id

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