Local Anesthesia for Nerve Damage

Recruiting at 1 trial location

Overseen By Pablo R Velazquez, Resident

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Cleveland Dental Institute

Disqualifiers: Medical conditions, allergies, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether two local anesthetics, articaine 4% and lidocaine 2%, could cause nerve damage during an Inferior Alveolar Nerve Block (IANB), a common dental procedure. Participants will be randomly assigned to receive either articaine or lidocaine and monitored for signs of nerve damage, such as tingling or numbness, for three months. Individuals who require this type of dental anesthesia and are generally healthy may be suitable candidates. As a Phase 1 trial, this research aims to understand how these anesthetics work in people, offering participants the chance to contribute to important early-stage research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does list 'medications' as an exclusion criterion, which might mean certain medications could disqualify you from participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both articaine and lidocaine are generally safe for numbing an area. One study found these anesthetics linked to a small number of nerve damage cases, with articaine involved in 33% and lidocaine in 25% of these cases. This indicates that nerve damage can occur, but it is uncommon.

Another study found that articaine and lidocaine perform similarly in numbing, with success rates of 24% for articaine and 23% for lidocaine. Some patients reported a sensation like an electric shock during articaine injections, possibly indicating the needle touched a nerve, though this was rare.

Overall, both treatments are usually well-tolerated, with a small risk of nerve-related side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Articaine for nerve damage because it's a local anesthetic with a higher lipid solubility than standard Lidocaine. This means it can potentially penetrate nerve membranes more effectively, providing better and longer-lasting numbness with a lower dose. Articaine also contains 1:200,000 epinephrine, which may reduce blood flow and prolong its numbing effects compared to Lidocaine's 1:100,000 formulation. These features could make Articaine a more efficient option for managing pain associated with nerve damage.

What evidence suggests that this trial's treatments could be effective for nerve damage?

In this trial, participants will receive either articaine or lidocaine to numb the area around a specific nerve in the jaw. Research has shown that both articaine and lidocaine effectively serve this purpose. One study found that articaine had a 24% success rate in numbing, while lidocaine had a 23% success rate, indicating similar effectiveness. Another study found that articaine controlled pain better than lidocaine during dental work. Although rare, both articaine and lidocaine have been linked to cases of nerve damage. Articaine typically works faster and is less painful to administer than other local anesthetics. Overall, both are reliable for numbing during dental procedures. ^{1 4 6 7 8}

Who Is on the Research Team?

Ahmed A Hashem, PhD

Principal Investigator

Cleveland Dental Institute

Waleed Elmallah, PhD

Principal Investigator

Cleveland Dental Institute

Are You a Good Fit for This Trial?

This trial is for individuals who require an Inferior Alveolar nerve Block (IANB) and are at risk of mandibular or inferior alveolar nerve injury. Specific eligibility criteria details are not provided, but typically include adults in good health without conflicting medical conditions.

Inclusion Criteria

Healthy patient

I need a nerve block injection.

Exclusion Criteria

Allergies

Pregnancy and breastfeeding

I am currently taking medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 4% Articaine or 2% Lidocaine for Inferior Alveolar Nerve Block

1 day

1 visit (in-person)

Follow-up

Participants are monitored for signs of nerve paresthesia using Electromyograph for 3 months

3 months

Regular monitoring visits

What Are the Treatments Tested in This Trial?

Interventions

• Articaine
• Lidocaine

Trial Overview

The study compares the risk of nerve damage after using two types of local anesthesia: Articaine (4% with 1:200,000 epinephrine) versus Lidocaine (2% with 1:100,000 epinephrine). It's a blind test where neither patients nor doctors know which drug is used.

How Is the Trial Designed?

Group I: Articaine Experimental Treatment 1 Intervention

Inferior Alveolar Nerve block using Articaine 4% with 1:200,000 epinephrine local anesthetic

Group II: Lidocaine Active Control 1 Intervention

Inferior Alveolar Nerve block using 2% lidocaine with 1:100,000 epinephrine local anesthetic

Articaine is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Orabloc for:

• Local anesthesia for dental procedures

Approved in United States as Articaine for:

• Local anesthesia for dental procedures

Approved in Canada as Orabloc for:

• Local anesthesia for dental procedures

Who Is Running the Clinical Trial?

Cleveland Dental Institute

Lead Sponsor

Trials

6

Recruited

440+

Published Research Related to This Trial

In a study involving 162 children, mandibular nerve block provided significantly more effective local anaesthesia compared to maxillary infiltration during dental procedures.

While both articaine and prilocaine were similarly effective for most procedures, children receiving prilocaine experienced 1.5 times more pain during the removal of the coronal pulp compared to those receiving articaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of articaine and prilocaine local anaesthesia for pulpotomy of maxillary and mandibular primary molars. Yilmaz, Y., Eyuboglu, O., Keles, S.[2019]

In a study involving 24 rats, injections of 4% articaine and 2% lidocaine showed varying levels of inflammatory response around the mental nerve, with articaine causing moderate inflammation and lidocaine causing light inflammation, indicating a potential difference in their effects.

Despite the observed inflammation, no direct damage to the nerve structure was found, suggesting that while articaine may not be toxic to the nerve, further research is needed to understand its possible link to cases of paresthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of articaine on mental nerve anterior portion: histological analysis in rats. Baroni, DB., Franz-Montan, M., Cogo, K., et al.[2013]

Articaine, introduced in 1976 and widely used since 1986, has become the most popular local anesthetic in dentistry, surpassing lignocaine due to its effective pain control and rapid action.

Compared to older anesthetics, articaine offers enhanced safety and efficacy, making it a valuable addition to the local anesthetic options available to dental practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New anesthetics]. Malamed, SF.[2013]

Articaine is an effective and well-tolerated anesthetic for dental procedures, making it a suitable substitute for lignocaine based on a focused literature review.

There is a potential, though unproven, concern regarding a link between 4% concentrations of articaine and nerve damage, which practitioners should be aware of when using this anesthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Articaine hydrochloride: a safe alternative to lignocaine? Wells, JP., Beckett, H.[2018]

In a study of 82 patients undergoing cataract surgery, 2% articaine provided a faster onset of peribulbar anaesthesia, with an average readiness time of 4.2 minutes compared to 7.2 minutes for the bupivacaine/lidocaine mixture.

Articaine resulted in a denser block with significantly reduced eye movement scores at multiple time intervals, while showing a quicker offset of the anaesthesia, indicating its efficacy and safety as an alternative local anaesthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of articaine and bupivacaine/lidocaine for peribulbar anaesthesia by inferotemporal injection. Allman, KG., Barker, LL., Werrett, GC., et al.[2019]

Articaine is twice as effective as lidocaine but acts three times more slowly, suggesting it may be a useful option for certain local anesthesia applications.

Carbizocaine, a new long-acting anesthetic, was found to be 40 times more effective than articaine at a neutral pH, with a slower and prolonged action, indicating its potential for longer-lasting pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of articaine on isolated peripheral nerves]. Stankovicová, T., Stolc, S.[2017]

Recent studies indicate that short-acting local anesthetics like chloroprocaine, articaine, and prilocaine are effective for ambulatory spinal anesthesia, showing fast onset and quick recovery with minimal side effects such as transient neurologic symptoms.

Chloroprocaine is particularly advantageous for very short surgeries, while articaine and prilocaine are suitable for slightly longer procedures, making them appealing options in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-acting spinal anesthesia in the ambulatory setting. Förster, JG.[2014]

Articaine is a fast-acting local anesthetic that is effective for various dental and regional anesthesia procedures, showing similar clinical effects to other short-acting anesthetics like lidocaine and prilocaine.

It is considered safe for use in both normal and special populations, with no conclusive evidence of increased neurotoxicity, making it suitable for procedures requiring quick onset and short duration of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Articaine: a review of its use for local and regional anesthesia. Snoeck, M.[2022]

Articaine hydrochloride is considered a safe and effective local anaesthetic for dental procedures, with no evidence suggesting it poses a higher risk of causing paraesthesia compared to other local anaesthetics.

The article reviews the pharmacology and efficacy of articaine, highlighting its benefits while addressing safety concerns, particularly regarding the rare occurrence of nerve paraesthesia after nerve block injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Articaine hydrochloride: is it the solution? Kakroudi, SH., Mehta, S., Millar, BJ.[2022]

Citations

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mdpi.com

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A study reported that prilocaine was associated with 34% of cases of nerve damage, followed by articaine and lidocaine, with 33% and 25%, ...

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cureus.com

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... articaine has less pain, faster effect and less adverse reactions. ... Efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve ...

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accessdata.fda.gov

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Reference ID: 5618647 - accessdata.fda.gov

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002817714616184

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cdn.vivarep.com

cdn.vivarep.com/contrib/va/documents/al_lib_68.2016331352289307.pdf

Articaine and Paresthesia

Seven patients experienced an electric shock-type sensation during the injection, suggesting that the nerve was injured by the needle. Five patients reported no ...