Status:
COMPLETED
Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Collaborating Sponsors:
Henley Ion
Conditions:
Local Anesthesia Injection Pain
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06874244
Start Date
August 1 2024
End Date
July 1 2025
Last Update
November 19 2025
Active Locations (1)
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1
LSUHSC School of Dentistry
New Orleans, Louisiana, United States, 70119