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This study will assess the efficacy of two local anesthetics (2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine) in reducing post-operative pain in patients receiving endodontic treatment.
The goal of this study is to assess the efficacy of 2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine in reducing post-operative pain in patients with symptomatic irreversible pulpitis on a mandibular tooth that receive endodontic treatment. Participants of this study will include patients that present to the University of Washington Endodontic clinic and fit the inclusion criteria of being >18 years old, healthy (ASA I or II) and having a diagnosis of symptomatic irreversible pulpitis on a mandibular tooth, that is willing to undergo endodontic treatment in two visits. Upon diagnosis, and informed consent, patients will be asked to participate in this study. If enrolled in the study, participants will receive standard endodontic treatment with temporary placement of Calcium Hydroxide medicament within the canals of the tooth and placement of a temporary filling. They will then be randomized to receive an inferior alveolar nerve block with 1 cartridge (1.8mL) of either 2% lidocaine 1:100,000 epinephrine or 0.5% bupivicaine 1:200,000 epinephrine. Patients will be given a form to track their pain levels for the next 72 hours, that they will return at a follow up visit. This form will use the Heft-Parker visual analog pain scale to track pain levels as well as ask participants to track their use of over the counter analgesics, in particular, Advil/ibuprofen. The pain tracking form will be returned to the clinic and root canal will be completed also at this follow up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Lidocaine 1:100,000 epinephrine | Active Comparator | Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 2% Lidocaine 1:100,000 epinephrine following endodontic treatment. |
|
| 0.5% bupivicaine 1:200,000 epinephrine | Active Comparator | Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthetic | Drug | Patients will receive inferior alveolar nerve block injection following endodontic treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Level 6 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale |
| Post-operative Pain Level 12 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Patients will be asked to track pain level at 12 hours post-operatively on a visual analog scale |
| Post-operative Pain Level 24 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Patients will be asked to track pain level at 24 hours post-operatively on a visual analog scale |
| Post-operative Pain Level 48 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Patients will be asked to track pain level at 48 hours post-operatively on a visual analog scale |
| Post-operative Pain Level 72 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avina Paranjpe | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington- School of Dentistry | Seattle | Washington | 98112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24493972 | Background | Al-Kahtani A. Effect of long acting local anesthetic on postoperative pain in teeth with irreversible pulpitis: Randomized clinical trial. Saudi Pharm J. 2014 Jan;22(1):39-42. doi: 10.1016/j.jsps.2013.01.004. Epub 2013 Jan 26. | |
| 6387029 | Background | Dunsky JL, Moore PA. Long-acting local anesthetics: a comparison of bupivacaine and etidocaine in endodontics. J Endod. 1984 Sep;10(9):457-60. doi: 10.1016/S0099-2399(84)80270-8. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% Lidocaine 1:100,000 Epinephrine | Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 2% Lidocaine 1:100,000 epinephrine following endodontic treatment. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment. |
| FG001 | 0.5% Bupivicaine 1:200,000 Epinephrine | Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2% Lidocaine 1:100,000 Epinephrine | Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 2% Lidocaine 1:100,000 epinephrine following endodontic treatment. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Post-operative Pain Level 6 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Posted | Mean | Standard Deviation | units on a scale | Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale |
|
Patients were followed up for 72 hours to check for any adverse reactions
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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 | 2% Lidocaine 1:100,000 Epinephrine | Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 2% Lidocaine 1:100,000 epinephrine following endodontic treatment. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment. |
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Limitations/future direction
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Avina Paranjpe | University of Washington | 206-543-5044 | avina@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2025 | Apr 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics
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| Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale |
| 24778680 | Background | Moradi S, Naghavi N. Comparison of bupivacaine and lidocaine use for postoperative pain control in endodontics. Iran Endod J. 2010 Winter;5(1):31-5. Epub 2010 Feb 20. |
| 22794202 | Background | Parirokh M, Yosefi MH, Nakhaee N, Manochehrifar H, Abbott PV, Reza Forghani F. Effect of bupivacaine on postoperative pain for inferior alveolar nerve block anesthesia after single-visit root canal treatment in teeth with irreversible pulpitis. J Endod. 2012 Aug;38(8):1035-9. doi: 10.1016/j.joen.2012.04.012. Epub 2012 May 30. |
| 0.5% Bupivicaine 1:200,000 Epinephrine |
Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment. |
|
|
| Primary | Post-operative Pain Level 12 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Posted | Mean | Standard Deviation | units on a scale | Patients will be asked to track pain level at 12 hours post-operatively on a visual analog scale |
|
|
|
| Primary | Post-operative Pain Level 24 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Posted | Mean | Standard Deviation | units on a scale | Patients will be asked to track pain level at 24 hours post-operatively on a visual analog scale |
|
|
|
| Primary | Post-operative Pain Level 48 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Posted | Mean | Standard Deviation | units on a scale | Patients will be asked to track pain level at 48 hours post-operatively on a visual analog scale |
|
|
|
| Primary | Post-operative Pain Level 72 Hours on a Visual Analog Scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Posted | Mean | Standard Deviation | units on a scale | Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 0.5% Bupivicaine 1:200,000 Epinephrine | Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |