Clinical Evaluation of No Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
- Conditions
- Local Anesthesia Injection Pain
- Interventions
- Drug: Iontophoresis of Tetracaine and oxymetazolineDrug: Local Anesthesia (lidocaine hydrochloride)
- Registration Number
- NCT06874244
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Iontophoresis of Tetracaine and oxymetazoline Iontophoresis of Tetracaine and oxymetazoline - Local Anesthesia (lidocaine hydrochloride) Local Anesthesia (lidocaine hydrochloride) -
- Primary Outcome Measures
Name Time Method 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.
Cold pulp test Up to 1 hour The pulpal response will be assessed using a cold pulp test as yes/ no response.
Electric pulp test Up to 1 hour The pulpal response will be assessed using an electric pulp test as yes/ no and if yes, from a scale of 0 to 72 with a higher number suggesting more anesthesia.
- Secondary Outcome Measures
Name Time Method 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.
Related Research Topics
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Trial Locations
- Locations (1)
LSUHSC School of Dentistry
🇺🇸New Orleans, Louisiana, United States