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Manufacture of drug discontinued before any participants could be enrolled.
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The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.
In June 2016, an intranasal delivery system of local anesthesia called Kovanaze, gained FDA approval. Kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face.
With the ability to avoid the traditional painful injection Kovanaze offers promise in the field of maxillary anesthesia and this study intends to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kovanaze Nasal Spray (General Practice) | Experimental | Adults who require restorations in the maxillary teeth that would need local anesthesia |
|
| Articaine Injections (General Practice | Active Comparator | Adults who require restorations in the maxillary teeth that would need local anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kovanaze Nasal Spray | Drug | Intra-nasal local anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of pupal anesthesia | % dental procedures completed without the need for rescue anesthesia | immediately after dental procedure, an average of 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Spread of anesthesia | Number of teeth anesthetized in maxillary arch | immediately after dental procedure, an average of 3 hours |
| Change in Anxiety level | Modified Dental Anxiety Scale - 5 item questionnaire assessing dental visit related anxiety on a 5 point scale ranging from 1 (not anxious) to 5 (extremely anxious). Scores range from 5 to 25. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parthasarathy Madurantakam, DDS, PhD | Virginia Commonwealth University | Principal Investigator |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010483 | Periapical Diseases |
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| ID | Term |
|---|---|
| D013748 | Tetracaine |
| D010109 | Oxymetazoline |
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Articaine Injection | Drug | Local anesthetic |
|
|
| from baseline to immediately after dental procedure |
| Change in Blood pressure | systolic and diastolic blood pressure will be assessed before and after the dental procedure | from baseline to immediately after dental procedure |
| Change in heart rate | from baseline to immediately after dental procedure |
| Change in pain | Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm) | from baseline to immediately after dental procedure |
| Satisfaction with Kovanaze | 8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze | immediately after dental procedure, an average of 3 hours |
| Number of post treatment anesthesia side effects | Phone survey asking about any side effects experienced from the anesthesia | 24 hours |
| D007571 |
| Jaw Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |