Validating a New Non-invasive Approach to Testing Lidocaine Effectiveness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-03-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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ADHD Controls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Reports getting numb at dentist

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.

Group Type ACTIVE_COMPARATOR

Lidocaine gel

Intervention Type DRUG

Lidocaine gel 5%, PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

Placebo

Intervention Type DRUG

PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

Injected lidocaine

Intervention Type DRUG

Standard FDA-approved dental injectable lidocaine

Reports trouble getting numb at dentist

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.

Group Type ACTIVE_COMPARATOR

Lidocaine gel

Intervention Type DRUG

Lidocaine gel 5%, PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

Placebo

Intervention Type DRUG

PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

Injected lidocaine

Intervention Type DRUG

Standard FDA-approved dental injectable lidocaine

Interventions

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Lidocaine gel

Lidocaine gel 5%, PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

Intervention Type DRUG

Placebo

PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

Intervention Type DRUG

Injected lidocaine

Standard FDA-approved dental injectable lidocaine

Intervention Type DRUG

Other Intervention Names

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Intervention Control gel Current practice

Eligibility Criteria

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Inclusion Criteria

\- Report "get numb at dentist"

\- Report "trouble getting numb at dentist"

Exclusion Criteria

* ADHD, ADD, and other inattention disorders
* Known adverse reactions to lidocaine;
* Epilepsy
* IQ \<80
* Severe head trauma
* Birth weight \<2270 grams
* Severe autism
* Generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness)
* Mouth sores
* Ehlers Danlos syndrome
* Red hair
* Current pregnancy
* Treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers

Angiotensin Converting Enzyme Inhibitors

* Alacepril (not available in US)
* Benazepril (Lotensin)
* Captopril (trade name Capoten)
* Cilazapril (Inhibace)
* Delapril (not available in US)
* Enalapril (Vasotec/Renitec)
* Fosinopril (Fositen/Monopril)
* Imidapril (Tanatril)
* Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)
* Moexipril (Univasc)
* Perindopril (Coversyl/Aceon/Perindo)
* Quinapril (Accupril)
* Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)
* Spirapril (Renormax)
* Temocapril (not available in US)
* Teprotide (but not active by oral administration and not used in US)
* Trandolapril (Mavik/Odrik/Gopten)
* Zofenopril

Angiotensin receptor blockers

* Azilsartan (Edarbi)
* Candesartan (Atacand)
* Eprosartan (Teveten)
* Fimasartan (Kanarb)
* Irbesartan (Avapro)
* Losartan (Cozaar)
* Olmesartan (Benicar/Olmetec)
* Telmisartan (Micardis)
* Valsartan (Diovan)

Aldosterone antagonists

* Spironolactone (Aldactone)
* Eplerenone (Inspra)

Renin inhibitors - Aliskiren (Tekturna, Rasilez)

Other potassium elevating agents

* Antibiotics, including penicillin G and trimethoprim
* Azole antifungals
* Beta-blockers
* Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn berries
* Heparin
* Nonsteroidal anti-inflammatory medications (NSAIDs)
* Oral contraceptives containing drospirenone

Arm 2 Eligibility

* Known adverse reactions to lidocaine;
* Epilepsy
* IQ \<80
* Severe head trauma
* Birth weight \<2270 grams
* Severe autism
* Generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness)
* Mouth sores
* Ehlers Danlos syndrome
* Red hair
* Current pregnancy
* Treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers

Angiotensin Converting Enzyme Inhibitors

* Alacepril (not available in US)
* Benazepril (Lotensin)
* Captopril (trade name Capoten)
* Cilazapril (Inhibace)
* Delapril (not available in US)
* Enalapril (Vasotec/Renitec)
* Fosinopril (Fositen/Monopril)
* Imidapril (Tanatril)
* Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)
* Moexipril (Univasc)
* Perindopril (Coversyl/Aceon/Perindo)
* Quinapril (Accupril)
* Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)
* Spirapril (Renormax)
* Temocapril (not available in US)
* Teprotide (but not active by oral administration and not used in US)
* Trandolapril (Mavik/Odrik/Gopten)
* Zofenopril

Angiotensin receptor blockers

* Azilsartan (Edarbi)
* Candesartan (Atacand)
* Eprosartan (Teveten)
* Fimasartan (Kanarb)
* Irbesartan (Avapro)
* Losartan (Cozaar)
* Olmesartan (Benicar/Olmetec)
* Telmisartan (Micardis)
* Valsartan (Diovan)

Aldosterone antagonists

* Spironolactone (Aldactone)
* Eplerenone (Inspra)

Renin inhibitors

\- Aliskiren (Tekturna, Rasilez)

Other potassium elevating agents

* Antibiotics, including penicillin G and trimethoprim
* Azole antifungals
* Beta-blockers
* Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn berries
* Heparin
* Nonsteroidal anti-inflammatory medications (NSAIDs)
* Oral contraceptives containing drospirenone

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes