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The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an "active" control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benzocaine | Active Comparator | serves as "active" control |
|
| TAC | Experimental | serves as comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| benzocaine | Drug | 20% benzocaine., topical placement onto site, minimal amount, for 1 minute |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale score | pre-op, insertion, every minute post-op for 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | three times pre-op, insertion, ten times post-op | |
| oxygen saturation | three times pre-op, insertion, ten times post-op | |
| heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Femme L Ambrosio, DDS | Contact | 858 603-6345 | femme.l.ambrosio@uth.tmc.edu | |
| Arthur H Jeske, DDS, PhD | Contact | 713 500 4506 | arthur.h.jeske@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Femme L Ambrosio, DDS | UT Health Science Center Houston | Principal Investigator |
| Arthur H Jeske, DDS, PhD | UT Health Science Center Houston | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Pediatric Dentistry Clinic Houston Medical Center | Recruiting | 6655 Travis Suite 460 | Texas | 77030 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2011 | |
| Reset | Jul 14, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2011 | Jul 14, 2011 |
| ID | Term |
|---|---|
| D014098 | Toothache |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D001566 | Benzocaine |
| ID | Term |
|---|---|
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| TAC alternate gel | Drug | use 1 pump, place topically onto site, leave for 1-3 minutes |
|
|
| three times pre-op, insertion, ten times post-op |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |