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

Trial Summary

What is the purpose of this trial?

This research aims to evaluate of the risk of nerve damage following the administration of articaine 4% and lidocaine 2% for Inferior Alveolar nerve Block (IANB). A Randomized Controlled Clinical Trial will be conducted where the patient will be randomly assigned to one the two groups; articaine 4% and Lidocaine 2%. The type of LA will be concealed to the operator, investigators and assessors. The patients will be monitored for any aigns of nerve parathesia for 3 months after the procedure.

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.

What evidence supports the effectiveness of the drug Articaine for nerve damage?

Articaine is effective for local and regional anesthesia, commonly used in dental procedures, and is similar in effectiveness to other local anesthetics like lidocaine. It is suitable for procedures needing a quick onset and short duration of anesthesia. ^{1 2 3 4 5}

Is local anesthesia with articaine or lidocaine safe for humans?

Articaine and lidocaine are generally considered safe for use as local anesthetics in humans, especially in dental procedures. While there is a rare risk of paraesthesia (a tingling or numb sensation) with articaine, studies have not shown it to be more risky than other local anesthetics. Both are well-tolerated, but practitioners should be cautious with higher concentrations due to a potential, though unproven, link to nerve damage. ^{1 3 6 7 8}

How is the drug Articaine different from other treatments for nerve damage?

Articaine is unique because it is a short-acting local anesthetic with a fast onset, making it suitable for procedures requiring quick pain relief. It is metabolized quickly due to an ester group in its structure, which is different from other anesthetics like lidocaine. ^{1 2 3 8 9}

Research Team

Waleed Elmallah, PhD

Principal Investigator

Cleveland Dental Institute

Ahmed A Hashem, PhD

Principal Investigator

Cleveland Dental Institute

Eligibility Criteria

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

I need a nerve block injection.

Healthy patient

Exclusion Criteria

Allergies

I am currently taking medication.

Pregnancy and breastfeeding

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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 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 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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of articaine and bupivacaine/lidocaine for peribulbar anaesthesia by inferotemporal injection. [2019]

2. Belgium pubmed.ncbi.nlm.nih.gov

[New anesthetics]. [2013]

3. New Zealand pubmed.ncbi.nlm.nih.gov

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

4. Slovakia pubmed.ncbi.nlm.nih.gov

[The effect of articaine on isolated peripheral nerves]. [2017]

5. Italy pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of articaine and prilocaine local anaesthesia for pulpotomy of maxillary and mandibular primary molars. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Articaine hydrochloride: is it the solution? [2022]

7. England pubmed.ncbi.nlm.nih.gov

Articaine hydrochloride: a safe alternative to lignocaine? [2018]

8. England pubmed.ncbi.nlm.nih.gov

Effect of articaine on mental nerve anterior portion: histological analysis in rats. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

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