Local Anesthesia Injection Pain
Conditions
Keywords
Local Anesthesia
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.
Interventions
Injection of lidocaine as local anesthesia
DRUGIontophoresis of Tetracaine and oxymetazoline
Injecting Tetracaine Hydrochloride 4% with 0.5% Oxymetazoline to the oral tissue using iontophoresis technique
Sponsors
Henley Ion
Louisiana State University Health Sciences Center in New Orleans
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain response in the gingiva | 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 | Up to 1 hour | The pulpal response will be assessed using a cold pulp test as yes/ no response. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Outcome results
None listed