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| Name | Class |
|---|---|
| American Association of Endodontists | OTHER |
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The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.
This project will be a double blind study comparing the efficacy of two different topical anesthetics used to reduce the pain associated with insertion of dental needles on the palatal mucosa. The two topical anesthetics being compared are 20% Benzocaine, and Pliaglis.
In order to complete a number of different dental procedures, it is often necessary to provide local anesthesia of the palate. Intraoral injections into the palatal mucosa are often uncomfortable and even painful. In an effort to increase patient comfort, a topical anesthetic is often used prior to the injection. Test subjects undergoing routine endodontic treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of the hard palate as part of the initial step in standard local anesthetic injection. At the injection site and prior to the needle stick, the mucosa will be topically anesthetized by using one of the two different test compounds (Benzocaine or Pliaglis). After the injection, patients will be asked to score the level of discomfort associated with the needle stick.
The purpose of the project is to determine if there is a clinical difference in the level of pain felt upon needle stick, between the two different topical anesthetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benzocaine | Active Comparator | Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. |
|
| Pliaglis | Experimental | Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pliaglis | Drug | Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale | The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain). | 2.5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian l Royle, DDS | University of Michigan department of Endodontics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Dental School | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Benzocaine | benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic. Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed |
| FG001 | Pliaglis | Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic. Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Benzocaine | benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic. Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale | The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain). | Posted | Mean | Full Range | mm | 2.5 minutes |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Benzocaine | benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic. Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Gonzalez | University of Michigan School of Dentistry | 734-763-3391 | carlosgc@umich.edu |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D013748 | Tetracaine |
| D001566 | Benzocaine |
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Benzocaine | Drug | Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic. |
|
|
| Articaine | Drug | Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed |
|
|
| BG001 | Pliaglis | Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic. Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Pliaglis | Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic. Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Pliaglis | Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic. Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed | 0 | 30 | 0 | 30 |
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| Aniline Compounds |
| D000588 | Amines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |