No Needle Dental Anesthesia for Injection Pain

Overseen By Amir Hossein Nejat, DDS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Louisiana State University Health Sciences Center in New Orleans

Must not be taking: Whitening agents, Long-term analgesics

Disqualifiers: Rampant caries, Chronic periodontitis, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 hour

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for numbing teeth during dental procedures: the traditional needle-based method and a needle-free option called iontophoresis of tetracaine and oxymetazoline, which uses a small electric current. Both methods aim to make dental procedures more comfortable by effectively numbing the teeth. The study seeks participants with at least 24 teeth, good oral hygiene, and the ability to attend scheduled dental visits. This trial may suit those who avoid dental care due to a fear of needles. As an Early Phase 1 trial, the research focuses on understanding how the needle-free method works in people, offering participants a chance to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking long-term pain relievers for other health conditions, you may not be eligible to participate.

What prior data suggests that iontophoresis for dental anesthesia is safe?

Research has shown that using iontophoresis with tetracaine and oxymetazoline is generally safe for dental anesthesia. Past studies reported no serious side effects or widespread issues with this treatment. It effectively and safely numbs the area for dental work.

Iontophoresis applies tetracaine and oxymetazoline without a needle, which many patients find less painful and stressful. This method has successfully provided sufficient numbness for dental procedures, with a success rate between 83% and 90%.

In contrast, lidocaine hydrochloride, used in another part of the study, is a common local anesthetic often used in dental work. It is usually well-tolerated and safe, with side effects being rare and mild.

Both treatments have been well-received in studies, making them promising options for reducing needle-related pain during dental procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about iontophoresis of tetracaine and oxymetazoline as a potential needle-free dental anesthesia option. Unlike standard local anesthesia, which typically involves injections with lidocaine to numb the area, this method uses a small electric current to deliver anesthetic drugs through the skin. This approach could significantly reduce the fear and discomfort associated with needles, making dental visits less daunting for patients. The use of tetracaine and oxymetazoline in combination also aims to enhance numbing efficiency while potentially minimizing side effects.

What evidence suggests that this trial's treatments could be effective for dental anesthesia?

Research has shown that iontophoresis with tetracaine and oxymetazoline, one of the treatments in this trial, can effectively numb teeth for dental work. This method acts faster than some other anesthetics, providing quicker numbness. Studies have found that more people experienced numbness with this combination than with others. Iontophoresis uses a machine with a gentle electrical current to deliver the anesthetic, helping to avoid the pain of needles. This approach is also associated with less pain and anxiety during dental procedures. Participants in this trial may receive this treatment or local anesthesia with lidocaine hydrochloride, which serves as the active comparator. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who need local anesthesia for dental procedures and are willing to try two different numbing methods. One method uses a needle and syringe, while the other uses a machine called iontophoresis that delivers the anesthetic through electrodes without penetrating the gums.

Inclusion Criteria

Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents

Subject should not be a pregnant female

Subject is able to provide their own informed consent

Exclusion Criteria

I do not have any uncontrolled illnesses.

I cannot tolerate the time needed for a medical procedure.

I have severe tooth decay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive dental anesthesia using either a conventional needle and syringe or iontophoresis

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for pain response and pulpal response after anesthesia administration

1 hour

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Iontophoresis of Tetracaine and oxymetazoline
• Local Anesthesia (lidocaine hydrochloride)

Trial Overview The study compares traditional needle-and-syringe delivery of lidocaine (a common numbing medication) with a no-needle technique using iontophoresis to administer tetracaine and oxymetazoline. The goal is to see which method provides effective dental anesthesia with less pain during administration.

How Is the Trial Designed?

Group I: Iontophoresis of Tetracaine and oxymetazoline Experimental Treatment 1 Intervention

Group II: Local Anesthesia (lidocaine hydrochloride) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials

123

Recruited

42,400+

Henley Ion

Collaborator

Trials

1

Recruited

20+

Citations

1. withpower.com withpower.com/trial/early-phase-1-local-anesthesia-injection-pain-7-2024-df77f

No Needle Dental Anesthesia for Injection Pain The goal is to see which method provides effective dental anesthesia with less pain during administration.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11618247/

The Anaesthetic Efficacy of Tetracaine and Oxymetazoline ... Tetracaine 2% with oxymetazoline 0.05% had a significantly more rapid onset than Co‐phenylcaine (4 min vs. 6 min, p < 0.05) and a longer ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03502135

Efficacy of Tetracaine/Oxymetazoline Nasal Spray for ... Purpose: To evaluate anesthetic efficacy and overall patient experience with use of Kovanaze tetracaine/oxymetazoline nasal spray for root canal treatment ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39286961/

The Anaesthetic Efficacy of Tetracaine and Oxymetazoline ... Eight participants reported dental numbness after administration of tetracaine 2% with oxymetazoline 0.05%, but only one participant after Co- ...

5. cureus.com cureus.com/articles/175358-iontophoresis-infused-deep-topical-anesthesia-and-injectable-local-anesthesia-for-dental-procedures-among-pediatric-patients-performances-and-consequences

Iontophoresis-Infused Deep Topical Anesthesia and ... Deep topical anesthesia achieved with the topical anesthetic spray infused by ionophoresis showed a significant reduction in pain and anxiety ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23690356/

Safety and efficacy of a novel nasal spray for maxillary ... No serious adverse events or systemic effects were observed. Tetracaine hydrochloride-oxymetazoline nasal spray appears to provide adequate and safe anesthesia ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27646144/

Intranasal Tetracaine and Oxymetazoline Three per cent tetracaine plus 0.05% oxymetazoline produced a success rate of between 83% and 90% in providing sufficient local anesthesia to perform dental ...