---
title: Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
nct_id: NCT06874244
overall_status: COMPLETED
phase: EARLY_PHASE1
sponsor: Louisiana State University Health Sciences Center in New Orleans
study_type: INTERVENTIONAL
primary_condition: Local Anesthesia Injection Pain
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06874244.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06874244"
ct_last_update_post_date: 2025-11-19
last_seen_at: "2026-05-12T07:22:29.014Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery

**Official Title:** Randomized Prospective Split Mouth Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery

**NCT ID:** [NCT06874244](https://clinicaltrials.gov/study/NCT06874244)

## Key Facts

- **Status:** COMPLETED
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Louisiana State University Health Sciences Center in New Orleans
- **Collaborators:** Henley Ion
- **Conditions:** Local Anesthesia Injection Pain
- **Start Date:** 2024-08-01
- **Completion Date:** 2025-07-01
- **CT.gov Last Update:** 2025-11-19

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Iontophoresis of Tetracaine and oxymetazoline** (EXPERIMENTAL)
- **Local Anesthesia (lidocaine hydrochloride)** (ACTIVE_COMPARATOR)

## Interventions

- **Local Anesthesia (lidocaine hydrochloride)** (DRUG) — Injection of lidocaine as local anesthesia
- **Iontophoresis of Tetracaine and oxymetazoline** (DRUG) — Injecting Tetracaine Hydrochloride 4% with 0.5% Oxymetazoline to the oral tissue using iontophoresis technique

## Primary Outcomes

- **Pain response in the gingiva** _(time frame: Up to 1 hour)_ — 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.
- **Cold pulp test** _(time frame: Up to 1 hour)_ — The pulpal response will be assessed using a cold pulp test as yes/ no response.

## Secondary Outcomes

- **Pain scale: Visual analog scale** _(time frame: Baseline and 2 minutes after delivery of anesthesia.)_
- **Beck's anxiety scale** _(time frame: Baseline and 2 minutes after delivery of anesthesia.)_

## Locations (1)

- LSUHSC School of Dentistry, New Orleans, Louisiana, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.lsuhsc school of dentistry|new orleans|louisiana|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06874244.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06874244*  
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