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Patients with painful molars will be randomly assigned to 2 different groups: GentleWave and EndoActivator. The root canals will be completed using identical protocols except in the mode of delivery and activation of irrigation (using either the GentleWave or EndoActivator). Postoperative pain and pain pill consumption will be measured for the 4 days following their root canal using a Visual Analog Scale and Pain Pill Log, respectively. The alternative hypothesis is that patients undergoing treatment using the GentleWave will experience less pain postoperatively and will consume fewer pain pills.
A 12-month follow up with exam and radiographs will be completed to evaluate healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GentleWave | Experimental | Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo. |
|
| EndoActivator | Active Comparator | Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multisonic vs Sonic activation of irrigants | Device | Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | 24 hours post-operative |
| 24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | 24 hr postoperatively |
| 48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | 48 hours post-operative |
| 48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | 48 hours post-operative |
| 72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | 72 hour post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Pill Consumption for Patients Seen From 09/2021-06/2021 | Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient. | Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment. |
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Inclusion Criteria:
• Adults, able to provide informed consent, with restorable symptomatic molars reporting preoperative pain ≥20mm on a 100mm Visual Analog Scale (VAS) during the previous 24 hours.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Bingham, DDS | Resident at the Center for Advanced Dental Education | Principal Investigator |
| Brian Judd, DDS | Resident at the Center for Advanced Dental Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University Center for Advanced Dental Education | St Louis | Missouri | 63104 | United States |
After enrollment, no patients were excluded from the study prior to assignment of group. However, the data for one participant in the GentleWave group was excluded from final data analysis because it was determined that their preoperative pain was insufficient for the study and they should not have been enrolled in the first place.
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| ID | Title | Description |
|---|---|---|
| FG000 | GentleWave | Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo. Multisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy. |
| FG001 | EndoActivator | Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona. Multisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GentleWave | Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo. Multisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy. |
| 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 | 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | Participants seen from 09/2020-06/2021 that completed and returned their paperwork. | Posted | Mean | Standard Deviation | score on a scale | 24 hours post-operative |
|
Through study completion, an average of 10 months.
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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 | GentleWave | Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo. Multisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Bingham | Saint Louis University | 208-851-0618 | davidbingham1623@gmail.com |
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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 | May 2, 2022 | Mar 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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| 72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 |
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). |
| 72 hours post-operative |
| 96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | 96 hours post-operative |
| 96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | 96 hours post-operative |
| Cone Beam Computed Tomography (CBCT) Healing Assessment | Each tooth root was classified as healed (no periapical radiolucency), healing (periapical radiolucency educed in size), or diseased (periapical radiolucency same size or larger). Pre-operative vs. post-operative periapical health evaluated using radiographs to compare the size of periapical radiolucencies present pre-op vs post-op. | 12 month recall |
| Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report | Teeth were classified as being clinically successful if the patient had no symptoms other than mild tenderness to percussion. Teeth were classified as failures if outside these parameters. | 12-month recall |
| Pain Pill Consumption for Patients Seen From 07/2021-03/2022 | Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient. | Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment. |
| EndoActivator |
Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona. Multisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy. |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Pre-operative pain | Measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | Mean | Standard Deviation | score on a scale |
|
| OG001 |
| EndoActivator |
Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona. Multisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy. |
|
|
|
| Primary | 24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | Participants seen from 07/2021-03/2022 that completed and returned their paperwork | Posted | Mean | Standard Deviation | score on a scale | 24 hr postoperatively |
|
|
|
|
| Primary | 48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | Participants seen from 09/2020-06/2021 that completed and returned their paperwork | Posted | Mean | Standard Deviation | score on a scale | 48 hours post-operative |
|
|
|
|
| Primary | 48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | Participants seen from 07/2021-03/2022 that completed and returned their paperwork | Posted | Mean | Standard Deviation | score on a scale | 48 hours post-operative |
|
|
|
|
| Primary | 72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | Participants seen from 09/2020-06/2021 that completed and returned their paperwork | Posted | Mean | Standard Deviation | score on a scale | 72 hour post-operative |
|
|
|
|
| Primary | 72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | Participants seen from 07/2021-03/2022 that completed and returned their paperwork | Posted | Mean | Standard Deviation | score on a scale | 72 hours post-operative |
|
|
|
|
| Primary | 96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | Participants seen from 09/2020-06/2021 that completed and returned their paperwork | Posted | Mean | Standard Deviation | score on a scale | 96 hours post-operative |
|
|
|
|
| Primary | 96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100). | Participants seen from 07/2021-03/2022 that completed and returned their paperwork | Posted | Mean | Standard Deviation | score on a scale | 96 hours post-operative |
|
|
|
|
| Primary | Cone Beam Computed Tomography (CBCT) Healing Assessment | Each tooth root was classified as healed (no periapical radiolucency), healing (periapical radiolucency educed in size), or diseased (periapical radiolucency same size or larger). Pre-operative vs. post-operative periapical health evaluated using radiographs to compare the size of periapical radiolucencies present pre-op vs post-op. | Patients that were able to return for a 12-month recall before the study ended. | Posted | Number | roots | 12 month recall | Roots (teeth have multiple roots) | Roots (teeth have multiple roots) |
|
|
|
|
| Primary | Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report | Teeth were classified as being clinically successful if the patient had no symptoms other than mild tenderness to percussion. Teeth were classified as failures if outside these parameters. | Patients that could return for a 12-month recall before study ended. | Posted | Number | teeth | 12-month recall | Teeth | Teeth |
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|
| Secondary | Pain Pill Consumption for Patients Seen From 09/2021-06/2021 | Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient. | Participants seen from 09/2020-06/2021 that completed and returned their paperwork | Posted | Mean | Standard Deviation | pills | Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment. |
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| Secondary | Pain Pill Consumption for Patients Seen From 07/2021-03/2022 | Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient. | Participants seen from 07/2021-03/2022 that completed and returned their paperwork | Posted | Mean | Standard Deviation | pills | Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment. |
|
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | EndoActivator | Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona. Multisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| Diseased |
|