NCT01530074

Brief Summary

The purpose of this study is to determine the contribution of the innervation of the contra-lateral mandibular nerve for the innervation of the lower lip area. The investigators hypothesis is that the sensation of the lower lip is contributed by both mandibular nerves (from both sides of the jaw).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable healthy

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

February 7, 2012

Last Update Submit

August 24, 2021

Conditions

Healthy

Keywords

Mandibular nerveMental nerveMandibular incisive nerveLocal anesthesiaNone, only healthy subjects will be enrolled in this study

Outcome Measures

Primary Outcomes (1)

  • Quantitative sensory test

    Measurement of sensory conduction of A-beta, A-delta, C-fibers of mandibular nerve, using electronic neurometer.

    15 minutes

Study Arms (1)

Study Group

EXPERIMENTAL
Procedure: Temporary blocking of mandibular nerve

Interventions

Temporary blocking of mandibular nervePROCEDURE

IM. Lidocaine 2% 7.2ML

Study Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects with no systemic diseases, chronic medication, past nerve injury, or sensory complaint.

You may not qualify if:

  • Hypersensitivity/allergy to local anesthetic materials
  • Systemic diseases, Chronic medication
  • Past nerve injury
  • Congenital or acquired deformity in the lower jaw
  • Past fractures/neoplasm of the lower jaw
  • Past surgery to the lower lip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Blal Kifah

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 9, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

August 27, 2021

Record last verified: 2021-08