Apical Periodontitis, Symptomatic Irreversible Pulpitis
Conditions
Brief summary
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.
Interventions
DEVICEMultisonic vs Sonic activation of irrigants
Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.
Sponsors
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report | 12-month recall | 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. |
| 96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 96 hours post-operative | 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). |
| Cone Beam Computed Tomography (CBCT) Healing Assessment | 12 month recall | 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. |
| 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 24 hours post-operative | 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 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 24 hr postoperatively | 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 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 48 hours post-operative | 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 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 48 hours post-operative | 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 Postoperative Pain for Patients Seen From 09/2020-06/2021 | 72 hour post-operative | 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 Postoperative Pain for Patients Seen From 07/2021-03/2022 | 72 hours post-operative | 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 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 96 hours post-operative | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Pill Consumption for Patients Seen From 07/2021-03/2022 | 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. | 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. |
| Pain Pill Consumption for Patients Seen From 09/2021-06/2021 | 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. | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 32 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | GentleWave | EndoActivator | Total |
|---|---|---|---|
| Age, Continuous | 44.33 years STANDARD_DEVIATION 14.4 | 43.44 years STANDARD_DEVIATION 11.98 | 43.87 years STANDARD_DEVIATION 13.1 |
| Pre-operative pain | 66.00 score on a scale STANDARD_DEVIATION 24.67 | 70.80 score on a scale STANDARD_DEVIATION 23.45 | 68.50 score on a scale STANDARD_DEVIATION 24.15 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 31 participants | 32 participants | 63 participants |
| Sex: Female, Male Female | 20 Participants | 19 Participants | 39 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 0 / 31 | 0 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
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).
Time frame: 24 hr postoperatively
Population: Participants seen from 07/2021-03/2022 that completed and returned their paperwork
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | 24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 12.86 score on a scale | Standard Deviation 18.65 |
| EndoActivator | 24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 17.00 score on a scale | Standard Deviation 18.69 |
p-value: 1Fisher Exact
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).
Time frame: 24 hours post-operative
Population: Participants seen from 09/2020-06/2021 that completed and returned their paperwork.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 14.75 score on a scale | Standard Deviation 17.91 |
| EndoActivator | 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 16.23 score on a scale | Standard Deviation 27.93 |
p-value: 0.63Fisher Exact
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).
Time frame: 48 hours post-operative
Population: Participants seen from 07/2021-03/2022 that completed and returned their paperwork
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | 48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 6.86 score on a scale | Standard Deviation 12.35 |
| EndoActivator | 48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 10.07 score on a scale | Standard Deviation 11.49 |
p-value: 1Fisher Exact
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).
Time frame: 48 hours post-operative
Population: Participants seen from 09/2020-06/2021 that completed and returned their paperwork
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | 48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 12.58 score on a scale | Standard Deviation 18.71 |
| EndoActivator | 48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 11.73 score on a scale | Standard Deviation 19.58 |
p-value: 0.63Fisher Exact
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).
Time frame: 72 hours post-operative
Population: Participants seen from 07/2021-03/2022 that completed and returned their paperwork
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | 72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 3.57 score on a scale | Standard Deviation 4.89 |
| EndoActivator | 72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 5.86 score on a scale | Standard Deviation 10.85 |
p-value: 0.6Fisher Exact
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).
Time frame: 72 hour post-operative
Population: Participants seen from 09/2020-06/2021 that completed and returned their paperwork
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | 72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 7.46 score on a scale | Standard Deviation 14.36 |
| EndoActivator | 72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 7.30 score on a scale | Standard Deviation 13.14 |
p-value: 0.57Fisher Exact
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).
Time frame: 96 hours post-operative
Population: Participants seen from 07/2021-03/2022 that completed and returned their paperwork
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | 96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 1.57 score on a scale | Standard Deviation 3.61 |
| EndoActivator | 96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 | 2.57 score on a scale | Standard Deviation 3.63 |
p-value: 1Fisher Exact
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).
Time frame: 96 hours post-operative
Population: Participants seen from 09/2020-06/2021 that completed and returned their paperwork
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | 96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 9.96 score on a scale | Standard Deviation 19.98 |
| EndoActivator | 96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 | 7.53 score on a scale | Standard Deviation 16.15 |
p-value: 1Fisher Exact
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.
Time frame: 12-month recall
Population: Patients that could return for a 12-month recall before study ended.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GentleWave | Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report | Success | 12 teeth |
| GentleWave | Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report | Failure | 0 teeth |
| EndoActivator | Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report | Success | 12 teeth |
| EndoActivator | Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report | Failure | 2 teeth |
p-value: 0.4993Chi-squared
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.
Time frame: 12 month recall
Population: Patients that were able to return for a 12-month recall before the study ended.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GentleWave | Cone Beam Computed Tomography (CBCT) Healing Assessment | Healed | 24 roots |
| GentleWave | Cone Beam Computed Tomography (CBCT) Healing Assessment | Healing | 4 roots |
| GentleWave | Cone Beam Computed Tomography (CBCT) Healing Assessment | Diseased | 0 roots |
| EndoActivator | Cone Beam Computed Tomography (CBCT) Healing Assessment | Healed | 24 roots |
| EndoActivator | Cone Beam Computed Tomography (CBCT) Healing Assessment | Healing | 4 roots |
| EndoActivator | Cone Beam Computed Tomography (CBCT) Healing Assessment | Diseased | 4 roots |
p-value: 0.18Chi-squared
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.
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.
Population: Participants seen from 07/2021-03/2022 that completed and returned their paperwork
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | Pain Pill Consumption for Patients Seen From 07/2021-03/2022 | 4.00 pills | Standard Deviation 3.82 |
| EndoActivator | Pain Pill Consumption for Patients Seen From 07/2021-03/2022 | 4.93 pills | Standard Deviation 8.02 |
p-value: 0.7t-test, 2 sided
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.
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.
Population: Participants seen from 09/2020-06/2021 that completed and returned their paperwork
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GentleWave | Pain Pill Consumption for Patients Seen From 09/2021-06/2021 | 5.08 pills | Standard Deviation 4.56 |
| EndoActivator | Pain Pill Consumption for Patients Seen From 09/2021-06/2021 | 6.63 pills | Standard Deviation 7.63 |
p-value: 0.52t-test, 2 sided