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

NCT ID: NCT06874244

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-07-01

Brief Summary

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.

Conditions

Local Anesthesia Injection Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Iontophoresis of Tetracaine and oxymetazoline

Group Type: EXPERIMENTAL

Iontophoresis of Tetracaine and oxymetazoline

Intervention Type: DRUG

Injecting Tetracaine Hydrochloride 4% with 0.5% Oxymetazoline to the oral tissue using iontophoresis technique

Local Anesthesia (lidocaine hydrochloride)

Group Type: ACTIVE_COMPARATOR

Local Anesthesia (lidocaine hydrochloride)

Intervention Type: DRUG

Injection of lidocaine as local anesthesia

Interventions

Local Anesthesia (lidocaine hydrochloride)

Injection of lidocaine as local anesthesia

Intervention Type: DRUG

Iontophoresis of Tetracaine and oxymetazoline

Injecting Tetracaine Hydrochloride 4% with 0.5% Oxymetazoline to the oral tissue using iontophoresis technique

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henley Ion

UNKNOWN

Sponsor Role: collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LSUHSC School of Dentistry

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

4944

Identifier Type: -

Identifier Source: org_study_id