Endodontic Disease, Post Operative Pain, Symptomatic Irreversible Pulpitis
Conditions
Keywords
endodontics, root canal, lidocaine, bupivicaine, ibuprofen, symptomatic irreversible pulpitis, post operative pain, heft parker visual analog scale
Brief summary
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.
Detailed description
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.
Interventions
DRUGLocal anesthetic
Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of symptomatic irreversible pulpitis on mandibular, posterior tooth * ASA I or II * \>18 years old
Exclusion criteria
* Maxillary or mandibular anterior tooth * Diagnosis of pulp necrosis or reversible pulpitis * Tooth deemed non-restorable * \<18 years old * ASA III, IV, or V * Patients who are contraindicated to take ibuprofen * Patients with allergies to any medications being assessed in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Level 6 Hours on a Visual Analog Scale | Patients will be asked to track pain levels at 6 post-operatively 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. |
| Post-operative Pain Level 12 Hours on a Visual Analog Scale | Patients will be asked to track pain level at 12 hours post-operatively 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. |
| Post-operative Pain Level 24 Hours on a Visual Analog Scale | Patients will be asked to track pain level at 24 hours post-operatively 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. |
| Post-operative Pain Level 48 Hours on a Visual Analog Scale | Patients will be asked to track pain level at 48 hours post-operatively 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. |
| Post-operative Pain Level 72 Hours on a Visual Analog Scale | Patients will be asked to track pain level at 72 hours post-operatively 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Root canal completed in a single visit | 1 | 0 |
Baseline characteristics
| Characteristic | 2% Lidocaine 1:100,000 Epinephrine | 0.5% Bupivicaine 1:200,000 Epinephrine | Total |
|---|---|---|---|
| Age, Continuous | 39.2 years STANDARD_DEVIATION 12.1 | 37.2 years STANDARD_DEVIATION 17.2 | 38.2 years STANDARD_DEVIATION 14.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
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.
Time frame: Patients will be asked to track pain level at 12 hours post-operatively on a visual analog scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidocaine 1:100,000 Epinephrine | Post-operative Pain Level 12 Hours on a Visual Analog Scale | 67.4 units on a scale | Standard Deviation 44.9 |
| 0.5% Bupivicaine 1:200,000 Epinephrine | Post-operative Pain Level 12 Hours on a Visual Analog Scale | 45.1 units on a scale | Standard Deviation 34.5 |
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.
Time frame: Patients will be asked to track pain level at 24 hours post-operatively on a visual analog scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidocaine 1:100,000 Epinephrine | Post-operative Pain Level 24 Hours on a Visual Analog Scale | 48.9 units on a scale | Standard Deviation 27.9 |
| 0.5% Bupivicaine 1:200,000 Epinephrine | Post-operative Pain Level 24 Hours on a Visual Analog Scale | 36.5 units on a scale | Standard Deviation 32.5 |
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.
Time frame: Patients will be asked to track pain level at 48 hours post-operatively on a visual analog scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidocaine 1:100,000 Epinephrine | Post-operative Pain Level 48 Hours on a Visual Analog Scale | 45.3 units on a scale | Standard Deviation 34.1 |
| 0.5% Bupivicaine 1:200,000 Epinephrine | Post-operative Pain Level 48 Hours on a Visual Analog Scale | 30.1 units on a scale | Standard Deviation 34.2 |
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.
Time frame: Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidocaine 1:100,000 Epinephrine | Post-operative Pain Level 6 Hours on a Visual Analog Scale | 64.2 units on a scale | Standard Deviation 43.9 |
| 0.5% Bupivicaine 1:200,000 Epinephrine | Post-operative Pain Level 6 Hours on a Visual Analog Scale | 43.1 units on a scale | Standard Deviation 43.1 |
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.
Time frame: Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidocaine 1:100,000 Epinephrine | Post-operative Pain Level 72 Hours on a Visual Analog Scale | 35.5 units on a scale | Standard Deviation 41.6 |
| 0.5% Bupivicaine 1:200,000 Epinephrine | Post-operative Pain Level 72 Hours on a Visual Analog Scale | 21.9 units on a scale | Standard Deviation 26.7 |