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Quantitative Sensory Testing of the Lower Lip After Inferior Alveolar Nerve Block, and Evaluation of the Role of the Contra-lateral Inferior Alveolar Nerve

This study is not yet open for participant recruitment.
Verified February 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
K Blal, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01530074
First received: February 7, 2012
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

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).


Condition Intervention
Healthy
 Procedure: Temporary blocking of mandibular nerve

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Quantitative sensory test [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Measurement of sensory conduction of A-beta, A-delta, C-fibers of mandibular nerve, using electronic neurometer.


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group Procedure: Temporary blocking of mandibular nerve
IM. Lidocaine 2% 7.2ML

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: K Blal, Dr. Blal Kifah, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01530074     History of Changes
Other Study ID Numbers: QSensory-HMO-CTIL
Study First Received: February 7, 2012
Last Updated: February 8, 2012
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Mandibular nerve
Mental nerve
Mandibular incisive nerve
Local anesthesia
None, only healthy subjects will be enrolled in this study

ClinicalTrials.gov processed this record on May 19, 2013