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The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.
The study will investigate the impact of postoperative supplemental long-acting bupivacaine on patient's pain, quality of life, and analgesic use following treatment for symptomatic irreversible pulpitis on patients with pre-operative pain levels of 5 or above (on a 0-10 analog scale). Bupivacaine will be compared to a placebo/mock injection and no injection to determine the difference in effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemental Postoperative Bupivacaine | Experimental | An additional injection, 1 carpule (1.8 mL) of 0.5% bupivacaine with 1:200,000 epinephrine, will be given to patients in this treatment arm, after their standard endodontic procedure is complete. |
|
| Mock/Placebo Injection | Placebo Comparator | If assigned to this arm, the patient will be shown the removal of a needle cap for an anesthetic syringe. The tip will be bent and placed in the patient's mouth, but no tissue penetration will occur. No solution of anesthetic will be delivered. |
|
| No Additional Injection | No Intervention | After standard endodontic procedure, no additional injection will be given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental Postoperative Bupivacaine | Drug | This is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (scored based on the OHIP-14 questionnaire) | Quality of life will be measured with a modified version of the OHIP-14 questionnaire. For each question, the answers correspond with a scale that runs from 0-4. A higher score corresponds with a lower quality of life, with 0 being great quality of life and 4 being very poor quality of life. | Day of operation and daily for four days immediately following endodontic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain level | Pain level as measured by the visual-analog scale (VAS) will be collected for four days following endodontic treatment. The scale is from 0-10, with 0 being no pain and 10 being the worst pain possible. | Day of operation and daily for four days immediately following endodontic treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorel E Burns, DDS | Contact | 212-998-9332 | leb409@nyu.edu | |
| NYUSOM IRB | Contact | 212-263-4110 | irb-info@nyulangone.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University College of Dentistry | Recruiting | New York | New York | 10010 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Three types of additional treatment after standard nonsurgical endodontic procedures may be given. These include an additional injection of bupivacaine, an additional mock or placebo injection, and no additional injection.
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| Placebo Injection | Drug | This intervention will appear to give patients an additional injection, but no additional drug will be given. |
|
| Analgesic use |
Use of self-administered analgesics including opioids will be measured postoperatively. The measure is binary- either usage of self-administered analgesics or no usage of self-administered analgesics. |
| Day of operation and daily for four days immediately following endodontic treatment |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |