Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator

Study Overview
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Brief Summary
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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.

Official Title
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Postoperative Pain and Healing of Molar Root Canal Teeth Using GentleWave vs. EndoActivator

Conditions
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Symptomatic Irreversible Pulpitis, Apical Periodontitis

Intervention / Treatment
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* Device: Multisonic vs Sonic activation of irrigants


Participation Criteria
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Eligibility Criteria
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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: Minors Pregnant women Prisoners Persons unable to adequately provide informed consent Non-restorable teeth Patients unable to sit in the dental chair for 3 hours Patients with compromised cardiac health requiring less than .08mg epinephrine Patients with a pacemaker Patients where Ibuprofen and Acetaminophen are contraindicated Patients unable to swallow pills Patients with pain originating somewhere other than the tooth in question Patients having taken analgesics within previous 6 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GentleWave<br>Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo. | Device: Multisonic vs Sonic activation of irrigants<br>* Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.<br>|
| Active Comparator: EndoActivator<br>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. | Device: Multisonic vs Sonic activation of irrigants<br>* Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |