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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate two different ways to administer the numbing solution. One is with a conventional needle and syringe the other method iontophoresis is a machine that supplies a weak current through electrodes that touch your teeth. Both methods use an anesthesia solution to make your teeth numb but the iontophoresis system contains no needle and the delivery device does not penetrate the gum.

Eligibility Criteria

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 have severe tooth decay.

I have long-term gum disease.

Timeline

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)

Treatment Details

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.

Participant Groups

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+