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| Name | Class |
|---|---|
| Henley Ion | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iontophoresis of Tetracaine and oxymetazoline | Experimental |
| |
| Local Anesthesia (lidocaine hydrochloride) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local Anesthesia (lidocaine hydrochloride) | Drug | Injection of lidocaine as local anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain response in the gingiva | 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. | Up to 1 hour |
| Cold pulp test | The pulpal response will be assessed using a cold pulp test as yes/ no response. | Up to 1 hour |
| Measure | Description | 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. |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSUHSC School of Dentistry | New Orleans | Louisiana | 70119 | United States |
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| Iontophoresis of Tetracaine and oxymetazoline | Drug | Injecting Tetracaine Hydrochloride 4% with 0.5% Oxymetazoline to the oral tissue using iontophoresis technique |
|
| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D008012 | Lidocaine |
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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