HealthyNCT01530074
Quantitative Sensory Testing of the Lower Lip After Inferior Alveolar Nerve Block, and Evaluation of the Role of the Contra-lateral Inferior Alveolar Nerve
A study testing Temporary blocking of mandibular nerve in people with Healthy, run by K Blal.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Temporary blocking of mandibular nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects with no systemic diseases, chronic medication, past nerve injury, or sensory complaint.
Who cannot join
- 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
About this study
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).
- Conditions
- Healthy
- Being tested
- Temporary blocking of mandibular nerve
- Keywords
- Mandibular nerve, Mental nerve, Mandibular incisive nerve, Local anesthesia, None, only healthy subjects will be enrolled in this study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary blocking of mandibular nerveProcedure or surgery
IM. Lidocaine 2% 7.2ML
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Procedure: Temporary blocking of mandibular nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative sensory test
Measurement of sensory conduction of A-beta, A-delta, C-fibers of mandibular nerve, using electronic neurometer.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2013
- Study completionDec 2013
Why it stopped: we have not succeeded in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- K Blal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, K Blal, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530074
- Sponsor's protocol ID
- QSensory-HMO-CTIL
- Status last verified
- Aug 2021
- First submitted
- 7 Feb 2012
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Testing of the Lower Lip After Inferior Alveolar Nerve Block, and Evaluation of the Role of the Contra-lateral Inferior Alveolar Nerve
- ClinicalTrials.gov ID
- NCT01530074
- Acronym / sponsor ID
- QSensory-HMO-CTIL
- Conditions
- Healthy
- Keywords
- Mandibular nerve, Mental nerve, Mandibular incisive nerve, Local anesthesia, None, only healthy subjects will be enrolled in this study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: we have not succeeded in recruiting patients
- Enrolment
- 60 participants (actual)
- Lead sponsor
- K BlalUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: Temporary blocking of mandibular nerve |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects with no systemic diseases, chronic medication, past nerve injury, or sensory complaint.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary blocking of mandibular nerveIM. Lidocaine 2% 7.2ML | Procedure or surgery | Study Group |
Primary outcome
Quantitative sensory test
Time frame: 15 minutes
Measurement of sensory conduction of A-beta, A-delta, C-fibers of mandibular nerve, using electronic neurometer.
Results and safety
The study was stopped early (reason given: we have not succeeded in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary blocking of mandibular nerve in people with Healthy, run by K Blal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: we have not succeeded in recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative sensory test (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.