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The purpose of this study is to evaluate patients with emergency pain and a sore (infected) tooth to determine if immediate root canal therapy is better at reducing pain, when compared to initial treatment with antibiotic and pain medication followed by root canal therapy. Each participant will be randomly assigned a number, which will determine if they will receive initial endodontic treatment that day or at a later date. Each participant will receive an anesthetic injection, pain medication and a prescription for an antibiotic. They will be asked to keep a diary to record their pain level after the injection and their pain levels and the amount and type of pain medication taken each day for the next 5 days. Participants who did not receive root canal therapy at the initial appointment will receive it after the 5 day postoperative period. The pain levels and medication use will be compared between the treatment and nontreatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| root canal treatment | Experimental | root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin) |
|
| no root canal treatment | Active Comparator | no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| root canal treatment, anesthesia, pain medications, and antibiotic | Procedure | Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use | pain measurement as assessed on a visual analog scale and pain medication usage definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success. | each day for 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Dentistry, Postle Hall | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11027389 | Background | Houck V, Reader A, Beck M, Nist R, Weaver J. Effect of trephination on postoperative pain and swelling in symptomatic necrotic teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Oct;90(4):507-13. doi: 10.1067/moe.2000.108960. | |
| 11487138 | Background | Nist E, Reader A, Beck M. Effect of apical trephination on postoperative pain and swelling in symptomatic necrotic teeth. J Endod. 2001 Jun;27(6):415-20. doi: 10.1097/00004770-200106000-00013. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Root Canal Treatment | root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin) root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| no root canal treatment, anesthesia, pain medications, and antibiotic | Procedure |
|
| 11491635 | Background | Henry M, Reader A, Beck M. Effect of penicillin on postoperative endodontic pain and swelling in symptomatic necrotic teeth. J Endod. 2001 Feb;27(2):117-23. doi: 10.1097/00004770-200102000-00016. |
| 12184419 | Background | Nusstein JM, Reader A, Beck M. Effect of drainage upon access on postoperative endodontic pain and swelling in symptomatic necrotic teeth. J Endod. 2002 Aug;28(8):584-8. doi: 10.1097/00004770-200208000-00005. |
| 17174670 | Background | Mickel AK, Wright AP, Chogle S, Jones JJ, Kantorovich I, Curd F. An analysis of current analgesic preferences for endodontic pain management. J Endod. 2006 Dec;32(12):1146-54. doi: 10.1016/j.joen.2006.07.015. Epub 2006 Oct 19. |
| 22099891 | Background | Wells LK, Drum M, Nusstein J, Reader A, Beck M. Efficacy of Ibuprofen and ibuprofen/acetaminophen on postoperative pain in symptomatic patients with a pulpal diagnosis of necrosis. J Endod. 2011 Dec;37(12):1608-12. doi: 10.1016/j.joen.2011.08.026. Epub 2011 Oct 1. |
| FG001 | no Root Canal Treatment | no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin) no root canal treatment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Root Canal Treatment | root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin) root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device. |
| BG001 | no Root Canal Treatment | no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin) no root canal treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use | pain measurement as assessed on a visual analog scale and pain medication usage definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success. | Posted | Number | percentage of participants | each day for 5 days |
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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 | Root Canal Treatment | root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin) root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device. | 0 | 56 | 0 | 56 | ||
| EG001 | no Root Canal Treatment | no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin) no root canal treatment | 0 | 52 | 0 | 52 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Drum | The Ohio State University | 6142923596 | drum.13@osu.edu |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Male |
|