NCT04093713

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 14, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

2 days

First QC Date

September 13, 2019

Last Update Submit

September 16, 2019

Conditions

Keywords

AnaesthesiaTechniqueextraoralLandmarks

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • positive aspiration rate

    1 second

Study Arms (1)

participants

OTHER

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

Interventions

blocking the inferior alveolar nerve using extroral landmarks

participants

Eligibility Criteria

Age5 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • fitness for nerve block local anaesthesia physically and psychologically

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hosh Isa Medical Center

Ḩawsh ‘Īsá, Al-Behera, 22728, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 19228214BACKGROUND
  • 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.

    PMID: 2120362BACKGROUND
  • 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.

    PMID: 6586971BACKGROUND
  • 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.

    PMID: 8509754BACKGROUND
  • 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.

    PMID: 268212BACKGROUND
  • 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.

    PMID: 23265758BACKGROUND
  • 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.

    PMID: 18167480BACKGROUND

MeSH Terms

Interventions

Nordefrin

Intervention Hierarchy (Ancestors)

NorepinephrineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Mosaad A Khalifah, DDSc

    Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mosaad A Khalifah, DDSc

CONTACT

Ahmed A Khalil, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer and researcher

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 18, 2019

Study Start

September 14, 2019

Primary Completion

September 16, 2019

Study Completion

September 16, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

No other researchers are involved in the study

Locations