Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery

Louisiana State University

Status and phase: Completed; Early Phase 1

Conditions: Local Anesthesia Injection Pain

Treatments: Drug: Iontophoresis of Tetracaine and oxymetazoline; Drug: Local Anesthesia (lidocaine hydrochloride)

Study type: Interventional

Funder types: Other

Identifiers

NCT06874244

4944

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is at least 18 years of age at the time of consent

Subject is able to provide their own informed consent

Subject has a minimum 24 teeth/subject and 6 teeth per quadrant

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

Subject must be able to speak and understand English

Subject is able and willing to return for all scheduled study visits

Subject to able to make dental appointments

Subject should not be a pregnant female

Subject meets the Level-I or Level-II classification criteria of the American

Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care

Exclusion criteria

• Subject has any of the following:

  • rampant caries
  • chronic periodontitis
  • salivary gland dysfunction

Subject is unable, for any reason, to tolerate the procedure time required to place the restorations

Subject has unacceptable oral hygiene (e.g., chronic moderate to heavy plaque accumulation along the gumline)

Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study

Subject is using a whitening agent at any time during this study.

Subject has history of allergic reaction to anesthetic medications

Subject with uncontrolled systemic disease or conditions

Subject is having acute or chronic myofascial pain or neuropathic conditions

Subject taking long-term analgesics for their systemic conditions

Subject presenting with acute dental pain

Subject requiring IV sedation or nitrous oxide sedation or oral sedation for anxiety

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Iontophoresis of Tetracaine and oxymetazoline

Experimental group

Treatment:

Drug: Iontophoresis of Tetracaine and oxymetazoline

Local Anesthesia (lidocaine hydrochloride)

Active Comparator group

Treatment:

Drug: Local Anesthesia (lidocaine hydrochloride)