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| Name | Class |
|---|---|
| Jacobi Medical Center | OTHER |
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This work will assess the reliability of a simple painless test for the effectiveness of the commonly used local anesthetic lidocaine
In prior tests with a convenience sample, subjects who reported that they had no trouble getting numb at the dentist, also got numb with lidocaine gel on the surface of the tongue. That numbness prevented them from being able to taste any flavor until the numbness had worn off. Subjects who reported having trouble getting numb at the dentist, could still taste flavors after the application of lidocaine.
This work will assess the reliability of a taste-based approach for creating a non-invasive way to test lidocaine effectiveness. The controlled trial will assess the ability of lidocaine oral gel to block taste (e.g., sweet) in 20 adults (ages 18-49) half with history of trouble getting numb at the dentist (Arm 2) and half with no trouble (Arm 1). To determine reproducibility, the taste-based test will be done 4 times on different days, twice with lidocaine and twice with a placebo, with randomization and double-blinding. These repeated results will be compared to a fifth assessment, against the "gold standard" of injection of lidocaine, assessed using a dental probe.
On each of four separate visits, in randomized order, the subject will be tested with tastants to the tongue twice after application of a lidocaine gel to the tongue and twice with a placebo gel. After a wait of two-minutes, the three tastants will be tested. The subject is blinded to the taste and the identity of the gel, which have been compounded to look the same.
On the fifth (last) visit, the subject will get an oral injection of lidocaine and the numbness assessed.
The results across the five tests will then be analyzed.
We are testing in separate studies NCT 03563573 and NCT 03676725 the prevalence of lidocaine ineffectiveness in those with Attention Deficit Hyperactivity Disorder (ADHD) and in the general population without ADHD. We believe the prevalence will be higher in ADHD. As a result, in this evaluation we have one Arm "gets numb at the dentist" where exclusion criteria includes ADHD and a second Arm "has trouble getting numb at the dentist" that does not have that exclusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reports getting numb at dentist | Active Comparator | Subjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day. |
|
| Reports trouble getting numb at dentist | Active Comparator | Subjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine gel | Drug | Lidocaine gel 5%, PEG with FD&C Blue No.1 (Brilliant Blue FCF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Taste sensation after lidocaine or placebo | The subject is blinded to the tastant and gel identities. The 3 tastants are tested in randomized order. After application of lidocaine gel or placebo to the tongue, and a wait of 2 minutes, the subject's tongue is rubbed with a swab that has been wet with the tastant on the subject's tongue. The subject is asked to identify the taste (e.g., sweet). Then, on a 5-point scale (0-4, ranging from none to very intense) they are asked to rate the intensity of the taste. The process is repeated for each of the three tastants. The consistency of the subject responses over the 4 sessions will be analyzed. | 4 visits each of 30 minutes within weeks of one another, average ~1 month total |
| Ability to feel pressure and discomfort after injection of lidocaine into the cheek | Inject lidocaine as would be done in a dental visit, assess numbness to pressure and discomfort using the Baker Wong FACES scale (0-10) scale of discomfort, ranging from none to intense pain. The effectiveness of lidocaine will be assessed, and then the results compared to Outcome 1. | 1 visit of 30 minutes after other 4 visits, average ~1 month total |
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Arm 1 Eligibility
Inclusion Criteria:
- Report "get numb at dentist"
Exclusion Criteria:
Angiotensin Converting Enzyme Inhibitors
Angiotensin receptor blockers
Aldosterone antagonists
Renin inhibitors - Aliskiren (Tekturna, Rasilez)
Other potassium elevating agents
Arm 2 Eligibility
Inclusion Criteria:
- Report "trouble getting numb at dentist"
Exclusion Criteria:
Angiotensin Converting Enzyme Inhibitors
Angiotensin receptor blockers
Aldosterone antagonists
Renin inhibitors
- Aliskiren (Tekturna, Rasilez)
Other potassium elevating agents
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| Name | Affiliation | Role |
|---|---|---|
| Michael Segal, MD PhD | PhenoSolve, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25447751 | Result | Infante MA, Moore EM, Nguyen TT, Fourligas N, Mattson SN, Riley EP. Objective assessment of ADHD core symptoms in children with heavy prenatal alcohol exposure. Physiol Behav. 2015 Sep 1;148:45-50. doi: 10.1016/j.physbeh.2014.10.014. Epub 2014 Oct 23. | |
| 18426576 | Result | Levitt JO. Practical aspects in the management of hypokalemic periodic paralysis. J Transl Med. 2008 Apr 21;6:18. doi: 10.1186/1479-5876-6-18. |
| Label | URL |
|---|---|
| Saul R (2014) "ADHD Does Not Exist". HarperCollins | View source |
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We plan to share with the FDA the validation of the taste approach to testing lidocaine effectiveness, as part of an IDE application.
9-12 months
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 29, 2020 | |
| Reset | Nov 20, 2020 | |
| Release | Jun 10, 2021 | |
| Unrelease | Jun 10, 2021 | |
| Release | Jun 11, 2021 | |
| Reset | Jul 1, 2021 | |
| Release | Jul 7, 2021 | |
| Reset | Jul 30, 2021 | |
| Release | Sep 18, 2023 | |
| Reset | Sep 19, 2023 | |
| Release | Aug 11, 2025 | |
| Reset | Aug 13, 2025 | |
| Release | Sep 25, 2025 | |
| Reset | Oct 14, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 29, 2020 | Nov 20, 2020 | |||
| Jun 10, 2021 | Jun 10, 2021 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Half the subjects will have a self-reported history of lidocaine working for them (effective) and half will have a history of difficulty getting numb (ineffective).
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The scoring of the lidocaine test is masked, using the coded identity of the tastes. The tastes will be assessed in random order. Each subject will have 2 tests with lidocaine gel and 2 with a placebo gel, in random order, each on different days. The subjects and other study personnel will be told not to discuss what the subject could or couldn't taste. Scoring will be done only after all testing on the subject is complete. A person not involved in the testing will keep track of which gels the subject has had.
|
| Placebo | Drug | PEG with FD&C Blue No.1 (Brilliant Blue FCF) |
|
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| Injected lidocaine | Drug | Standard FDA-approved dental injectable lidocaine |
|
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| 11143733 | Result | Nakai Y, Milgrom P, Mancl L, Coldwell SE, Domoto PK, Ramsay DS. Effectiveness of local anesthesia in pediatric dental practice. J Am Dent Assoc. 2000 Dec;131(12):1699-705. doi: 10.14219/jada.archive.2000.0115. |
| 24938135 | Result | Segal MM. We cannot say whether attention deficit hyperactivity disorder exists, but we can find its molecular mechanisms. Pediatr Neurol. 2014 Jul;51(1):15-6. doi: 10.1016/j.pediatrneurol.2014.04.014. Epub 2014 Apr 18. No abstract available. |
| 18174562 | Result | Segal MM, Rogers GF, Needleman HL, Chapman CA. Hypokalemic sensory overstimulation. J Child Neurol. 2007 Dec;22(12):1408-10. doi: 10.1177/0883073807307095. |
| 9212254 | Result | Segal MM, Douglas AF. Late sodium channel openings underlying epileptiform activity are preferentially diminished by the anticonvulsant phenytoin. J Neurophysiol. 1997 Jun;77(6):3021-34. doi: 10.1152/jn.1997.77.6.3021. |
| 23134619 | Result | Teicher MH, Polcari A, Fourligas N, Vitaliano G, Navalta CP. Hyperactivity persists in male and female adults with ADHD and remains a highly discriminative feature of the disorder: a case-control study. BMC Psychiatry. 2012 Nov 7;12:190. doi: 10.1186/1471-244X-12-190. |
| Rozanski RJ, Primosch RE, Courts FJ (1988). Clinical efficacy of 1 and 2% solutions of lidocaine. Pediatr Dent.10:287-90 | View source |
| Segal MM, Jurkat-Rott K, Levitt J, Lehmann-Horn F (2014) Hypokalemic periodic paralysis - an owner's manual | View source |
| Segal MM (2015) Devices, Kits, and Methods for Determining Sensitivity to Anesthetics. US Patent Filing 62/210,747, Filed 09/14/2015 | View source |
| Jun 11, 2021 | Jul 1, 2021 |
| Jul 7, 2021 | Jul 30, 2021 |
| Sep 18, 2023 | Sep 19, 2023 |
| Aug 11, 2025 | Aug 13, 2025 |
| Sep 25, 2025 | Oct 14, 2025 |