Local Anesthesia Injection PainEarly Phase 1NCT06874244
Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
A Early Phase 1 study testing Local Anesthesia (lidocaine hydrochloride) and Iontophoresis of Tetracaine and oxymetazoline in people with Local Anesthesia Injection Pain, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia Injection Pain
- What is being tested?
- Local Anesthesia (lidocaine hydrochloride) and Iontophoresis of Tetracaine and oxymetazoline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 Jul 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
United States1 site
LSUHSC School of Dentistry
New Orleans, Louisiana, 70119
About this study
Official title: Randomized Prospective Split Mouth Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
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
- Being tested
- Local Anesthesia (lidocaine hydrochloride), Iontophoresis of Tetracaine and oxymetazoline
- Keywords
- Local Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthesia (lidocaine hydrochloride)Drug
Injection of lidocaine as local anesthesia
Iontophoresis of Tetracaine and oxymetazolineDrug
Injecting Tetracaine Hydrochloride 4% with 0.5% Oxymetazoline to the oral tissue using iontophoresis technique
| Study group | Role | What they receive |
|---|---|---|
| Iontophoresis of Tetracaine and oxymetazoline | Experimental | Not described Receives: Drug: Iontophoresis of Tetracaine and oxymetazoline |
| Local Anesthesia (lidocaine hydrochloride) | Active comparator | Not described Receives: Drug: Local Anesthesia (lidocaine hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 hour
Cold pulp test
The pulpal response will be assessed using a cold pulp test as yes/ no response.
Measured: Up to 1 hour
Secondary outcomes (2)
Pain scale: Visual analog scale
Measured: Baseline and 2 minutes after delivery of anesthesia.
Beck's anxiety scale
Measured: Baseline and 2 minutes after delivery of anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Aug 2024
- Primary completion12 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Anesthesia Injection PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Henley Ion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874244
- Sponsor's protocol ID
- 4944
- Status last verified
- Jun 2025
- First submitted
- 3 Mar 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Split Mouth Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
- ClinicalTrials.gov ID
- NCT06874244
- Acronym / sponsor ID
- 4944
- Conditions
- Local Anesthesia Injection Pain
- Keywords
- Local Anesthesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Henley Ion
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iontophoresis of Tetracaine and oxymetazoline | Experimental | Drug: Iontophoresis of Tetracaine and oxymetazoline |
| Local Anesthesia (lidocaine hydrochloride) | Active comparator | Drug: Local Anesthesia (lidocaine hydrochloride) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- Subject has any of the following:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Anesthesia (lidocaine hydrochloride)Injection of lidocaine as local anesthesia | Drug | Local Anesthesia (lidocaine hydrochloride) |
| Iontophoresis of Tetracaine and oxymetazolineInjecting Tetracaine Hydrochloride 4% with 0.5% Oxymetazoline to the oral tissue using iontophoresis technique | Drug | Iontophoresis of Tetracaine and oxymetazoline |
Primary outcome
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.
2 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Local Anesthesia (lidocaine hydrochloride) and Iontophoresis of Tetracaine and oxymetazoline in people with Local Anesthesia Injection Pain, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain response in the gingiva (time frame: Up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.