Randomized Prospective Split Mouth Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
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.
Inclusion Criteria:
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:
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