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

NCT06874244 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 4944
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Local Anesthesia

Outcome Measures

Primary Outcomes (2)

• Pain response in the gingiva

  Pain response in the gingiva will be recorded as a yes/no after a painful stimulus is applied using a probe on the buccal and palatal soft tissues.

  Up to 1 hour

• Cold pulp test

  The pulpal response will be assessed using a cold pulp test as yes/ no response.

  Up to 1 hour

Secondary Outcomes (2)

• Pain scale: Visual analog scale

  Baseline and 2 minutes after delivery of anesthesia.

• Beck's anxiety scale

  Baseline and 2 minutes after delivery of anesthesia.

Study Arms (2)

Iontophoresis of Tetracaine and oxymetazoline

EXPERIMENTAL

Drug: Iontophoresis of Tetracaine and oxymetazoline

Local Anesthesia (lidocaine hydrochloride)

ACTIVE COMPARATOR

Drug: Local Anesthesia (lidocaine hydrochloride)

Interventions

Local Anesthesia (lidocaine hydrochloride) DRUG

Injection of lidocaine as local anesthesia

Local Anesthesia (lidocaine hydrochloride)

Iontophoresis of Tetracaine and oxymetazoline DRUG

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

Iontophoresis of Tetracaine and oxymetazoline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Henley Ion: collaborator

Study Sites (1)

LSUHSC School of Dentistry

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Interventions

Anesthesia, Local; Lidocaine; Oxymetazoline

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 13, 2025
• Study Start: August 1, 2024
• Primary Completion: June 12, 2025
• Study Completion: July 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)