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

Tracking Information
First Received Date ^ICMJE	February 7, 2012
Last Updated Date	February 8, 2012
Start Date ^ICMJE	March 2012
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 8, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01530074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Quantitative Sensory Testing of the Lower Lip After Inferior Alveolar Nerve Block, and Evaluation of the Role of the Contra-lateral Inferior Alveolar Nerve
Official Title ^ICMJE	Not Provided
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Procedure: Temporary blocking of mandibular nerve IM. Lidocaine 2% 7.2ML
Study Arm (s)	Experimental: Study Group Intervention: Procedure: Temporary blocking of mandibular nerve
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01530074
Other Study ID Numbers ^ICMJE	QSensory-HMO-CTIL
Has Data Monitoring Committee	No
Responsible Party	K Blal, Hadassah Medical Organization
Study Sponsor ^ICMJE	K Blal
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hadassah Medical Organization
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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