Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
Completed · Early Phase 1
Conditions studied: Local Anesthesia Injection Pain
In brief
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.
Key facts
- Study ID
- NCT06874244
- Run by
- Louisiana State University Health Sciences Center in New Orleans
- People needed
- 20
- Starts
- 2024-08-01
- Expected to finish
- 2025-07-01
- Last updated by the study team
- 2025-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- LSUHSC School of Dentistry — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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