A Novel Technique to Anaesthetize the Lower Jaw (NTALJ)

Inferior Alveolar Nerve Block: a Novel Intraoral Technique Depends on Extraoral Landmarks

This study introduces and evaluates a new technique for inferior alveolar nerve blocking.

Study Overview

• Status: Unknown
• Conditions: Inferior Alveolar Nerve Block
• Intervention / Treatment: Procedure: A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrin

Detailed Description

The study addresses a novel technique to anaesthetize the inferior alveolar nerve depending on extraoral landmarks. Volunteers will receive bilateral blocks and evaluation of the success rate and positive aspiration rate will be performed.

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al-Behera
    • Hosh Isa, Al-Behera, Egypt, 22728
      • Hosh Isa Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• fitness for nerve block local anaesthesia physically and psychologically

Exclusion Criteria:

• any disease or condition obstacles nerve block local anaesthesia administration such as hemophilia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: participants; participants are subjected to a novel technique to block the inferior alveolar nerve depending on extraoral landmarks	Procedure: A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrin; blocking the inferior alveolar nerve using extroral landmarks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of numbness (by questionnaire)	evaluation of the presence of numbness in the anatomical area supplied by the inferior alveolar nerve	3-10 minutes
absence of pain (by probing)	evaluation of absence of pain in the anatomical area supplied by the inferior alveolar nerve	3-10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive aspiration rate	evaluation of the presence of blood on drawing in two perpendicular planes	1 second

Collaborators and Investigators

• Sponsor: Mosaad Khalifah
• Investigators: Principal Investigator: Mosaad A Khalifah, DDSc, Kafrelsheikh University

Publications and helpful links

General Publications

• Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine buccal infiltration enhances the effectiveness of lidocaine inferior alveolar nerve block. Int Endod J. 2009 Mar;42(3):238-46. doi: 10.1111/j.1365-2591.2008.01507.x.
• Donkor P, Wong J, Punnia-Moorthy A. An evaluation of the closed mouth mandibular block technique. Int J Oral Maxillofac Surg. 1990 Aug;19(4):216-9. doi: 10.1016/s0901-5027(05)80395-9.
• Montagnese TA, Reader A, Melfi R. A comparative study of the Gow-Gates technique and a standard technique for mandibular anesthesia. J Endod. 1984 Apr;10(4):158-63. doi: 10.1016/S0099-2399(84)80120-X. No abstract available.
• McLean C, Reader A, Beck M, Meryers WJ. An evaluation of 4% prilocaine and 3% mepivacaine compared with 2% lidocaine (1:100,000 epinephrine) for inferior alveolar nerve block. J Endod. 1993 Mar;19(3):146-50. doi: 10.1016/s0099-2399(06)80510-8.
• Akinosi JO. A new approach to the mandibular nerve block. Br J Oral Surg. 1977 Jul;15(1):83-7. doi: 10.1016/0007-117x(77)90011-7.
• Boonsiriseth K, Sirintawat N, Arunakul K, Wongsirichat N. Comparative study of the novel and conventional injection approach for inferior alveolar nerve block. Int J Oral Maxillofac Surg. 2013 Jul;42(7):852-6. doi: 10.1016/j.ijom.2012.11.017. Epub 2012 Dec 21.
• Suazo Galdames IC, Cantin Lopez MG, Zavando Matamala DA. Inferior alveolar nerve block anesthesia via the retromolar triangle, an alternative for patients with blood dyscrasias. Med Oral Patol Oral Cir Bucal. 2008 Jan 1;13(1):E43-7.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 14, 2019
• Primary Completion (Anticipated): September 16, 2019
• Study Completion (Anticipated): September 16, 2019

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Anaesthesia; Technique; extraoral; Landmarks
• Additional Relevant MeSH Terms: Vasoconstrictor Agents; Nordefrin
• Other Study ID Numbers: Surg192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No other researchers are involved in the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No