An interventional study of Multisonic vs Sonic activation of irrigants in Symptomatic Irreversible Pulpitis and Apical Periodontitis, sponsored by St. Louis University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by St. Louis University · Not applicable, Interventional, and Treatment
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 63 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
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
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
Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 12-month recall
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.
Time frame: 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.
Time frame: 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.
| Milestone | GentleWave | EndoActivator |
|---|---|---|
| Started | 31 | 32 |
| Completed | 26 | 29 |
| Not completed | 5 | 3 |
| Withdrew: Lost to follow-up | 4 | 3 |
| Withdrew: Protocol violation | 1 | 0 |
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).
| score on a scale | GentleWave | EndoActivator |
|---|---|---|
| 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 14.75 ± 17.91 | 16.23 ± 27.93 |
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).
| score on a scale | GentleWave | EndoActivator |
|---|---|---|
| 24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 12.86 ± 18.65 | 17.00 ± 18.69 |
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).
| score on a scale | GentleWave | EndoActivator |
|---|---|---|
| 48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 12.58 ± 18.71 | 11.73 ± 19.58 |
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).
| score on a scale | GentleWave | EndoActivator |
|---|---|---|
| 48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 6.86 ± 12.35 | 10.07 ± 11.49 |
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).
| score on a scale | GentleWave | EndoActivator |
|---|---|---|
| 72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 7.46 ± 14.36 | 7.30 ± 13.14 |
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).
| score on a scale | GentleWave | EndoActivator |
|---|---|---|
| 72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 3.57 ± 4.89 | 5.86 ± 10.85 |
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).
| score on a scale | GentleWave | EndoActivator |
|---|---|---|
| 96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 9.96 ± 19.98 | 7.53 ± 16.15 |
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).
| score on a scale | GentleWave | EndoActivator |
|---|---|---|
| 96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 1.57 ± 3.61 | 2.57 ± 3.63 |
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.
| roots | GentleWave | EndoActivator |
|---|---|---|
| Healed | 24 | 24 |
| Healing | 4 | 4 |
| Diseased | 0 | 4 |
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.
| teeth | GentleWave | EndoActivator |
|---|---|---|
| Success | 12 | 12 |
| Failure | 0 | 2 |
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.
| pills | GentleWave | EndoActivator |
|---|---|---|
| Pain Pill Consumption for Patients Seen From 09/2021-06/2021 | 5.08 ± 4.56 | 6.63 ± 7.63 |
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.
| pills | GentleWave | EndoActivator |
|---|---|---|
| Pain Pill Consumption for Patients Seen From 07/2021-03/2022 | 4.00 ± 3.82 | 4.93 ± 8.02 |
Collected over Through study completion, an average of 10 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GentleWave | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| EndoActivator | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | GentleWave | EndoActivator | Total |
|---|---|---|---|
| Mean | 44.33 ± 14.40 | 43.44 ± 11.98 | 43.87 ± 13.10 |
| Sex: Female, Male(Participants) | GentleWave | EndoActivator | Total |
|---|---|---|---|
| Female | 20 | 19 | 39 |
| Male | 11 | 13 | 24 |
| Race and Ethnicity Not Collected(Participants) | GentleWave | EndoActivator | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | GentleWave | EndoActivator | Total |
|---|---|---|---|
| United States | 31 | 32 | 63 |
| Pre-operative pain(score on a scale) | GentleWave | EndoActivator | Total |
|---|---|---|---|
| Mean | 66.00 ± 24.67 | 70.80 ± 23.45 | 68.50 ± 24.15 |
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