Trial Outcomes & Findings for Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator (NCT NCT04552132)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

24 hours post-operative

Results posted on

2023-06-15

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	31	32
Overall Study COMPLETED	26	29
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	4	3
Overall Study Protocol Violation	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GentleWave n=31 Participants 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.	EndoActivator n=32 Participants 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.	Total n=63 Participants Total of all reporting groups
Sex: Female, Male Male	11 Participants n=31 Participants	13 Participants n=32 Participants	24 Participants n=63 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Age, Continuous	44.33 years STANDARD_DEVIATION 14.40 • n=31 Participants	43.44 years STANDARD_DEVIATION 11.98 • n=32 Participants	43.87 years STANDARD_DEVIATION 13.10 • n=63 Participants
Sex: Female, Male Female	20 Participants n=31 Participants	19 Participants n=32 Participants	39 Participants n=63 Participants
Region of Enrollment United States	31 participants n=31 Participants	32 participants n=32 Participants	63 participants n=63 Participants
Pre-operative pain	66.00 score on a scale STANDARD_DEVIATION 24.67 • n=31 Participants	70.80 score on a scale STANDARD_DEVIATION 23.45 • n=32 Participants	68.50 score on a scale STANDARD_DEVIATION 24.15 • n=63 Participants

PRIMARY outcome

Timeframe: 24 hours post-operative

Population: Participants seen from 09/2020-06/2021 that completed and returned their paperwork.

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).

Outcome measures

Outcome measures
Measure	GentleWave n=12 Participants 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.	EndoActivator n=15 Participants 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.
24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021	14.75 score on a scale Standard Deviation 17.91	16.23 score on a scale Standard Deviation 27.93

PRIMARY outcome

Timeframe: 24 hr postoperatively

Population: Participants seen from 07/2021-03/2022 that completed and returned their paperwork

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).

Outcome measures

Outcome measures
Measure	GentleWave n=14 Participants 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.	EndoActivator n=14 Participants 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.
24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022	12.86 score on a scale Standard Deviation 18.65	17.00 score on a scale Standard Deviation 18.69

PRIMARY outcome

Timeframe: 48 hours post-operative

Population: Participants seen from 09/2020-06/2021 that completed and returned their paperwork

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).

Outcome measures

Outcome measures
Measure	GentleWave n=12 Participants 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.	EndoActivator n=15 Participants 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.
48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021	12.58 score on a scale Standard Deviation 18.71	11.73 score on a scale Standard Deviation 19.58

PRIMARY outcome

Timeframe: 48 hours post-operative

Population: Participants seen from 07/2021-03/2022 that completed and returned their paperwork

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).

Outcome measures

Outcome measures
Measure	GentleWave n=14 Participants 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.	EndoActivator n=14 Participants 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.
48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022	6.86 score on a scale Standard Deviation 12.35	10.07 score on a scale Standard Deviation 11.49

PRIMARY outcome

Timeframe: 72 hour post-operative

Population: Participants seen from 09/2020-06/2021 that completed and returned their paperwork

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).

Outcome measures

Outcome measures
Measure	GentleWave n=12 Participants 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.	EndoActivator n=15 Participants 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.
72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021	7.46 score on a scale Standard Deviation 14.36	7.30 score on a scale Standard Deviation 13.14

PRIMARY outcome

Timeframe: 72 hours post-operative

Population: Participants seen from 07/2021-03/2022 that completed and returned their paperwork

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).

Outcome measures

Outcome measures
Measure	GentleWave n=14 Participants 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.	EndoActivator n=14 Participants 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.
72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022	3.57 score on a scale Standard Deviation 4.89	5.86 score on a scale Standard Deviation 10.85

PRIMARY outcome

Timeframe: 96 hours post-operative

Population: Participants seen from 09/2020-06/2021 that completed and returned their paperwork

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).

Outcome measures

Outcome measures
Measure	GentleWave n=12 Participants 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.	EndoActivator n=15 Participants 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.
96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021	9.96 score on a scale Standard Deviation 19.98	7.53 score on a scale Standard Deviation 16.15

PRIMARY outcome

Timeframe: 96 hours post-operative

Population: Participants seen from 07/2021-03/2022 that completed and returned their paperwork

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).

Outcome measures

Outcome measures
Measure	GentleWave n=14 Participants 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.	EndoActivator n=14 Participants 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.
96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022	1.57 score on a scale Standard Deviation 3.61	2.57 score on a scale Standard Deviation 3.63

PRIMARY outcome

Timeframe: 12 month recall

Population: Patients that were able to return for a 12-month recall before the study ended.

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.

Outcome measures

Outcome measures
Measure	GentleWave n=28 Roots (teeth have multiple roots) 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.	EndoActivator n=32 Roots (teeth have multiple roots) 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.
Cone Beam Computed Tomography (CBCT) Healing Assessment Healed	24 roots	24 roots
Cone Beam Computed Tomography (CBCT) Healing Assessment Healing	4 roots	4 roots
Cone Beam Computed Tomography (CBCT) Healing Assessment Diseased	0 roots	4 roots

PRIMARY outcome

Timeframe: 12-month recall

Population: Patients that could return for a 12-month recall before study ended.

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.

Outcome measures

Outcome measures
Measure	GentleWave n=12 Participants 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.	EndoActivator n=14 Teeth 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.
Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report Failure	0 teeth	2 teeth
Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report Success	12 teeth	12 teeth

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	GentleWave n=12 Participants 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.	EndoActivator n=15 Participants 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.
Pain Pill Consumption for Patients Seen From 09/2021-06/2021	5.08 pills Standard Deviation 4.56	6.63 pills Standard Deviation 7.63

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	GentleWave n=14 Participants 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.	EndoActivator n=14 Participants 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.
Pain Pill Consumption for Patients Seen From 07/2021-03/2022	4.00 pills Standard Deviation 3.82	4.93 pills Standard Deviation 8.02

Adverse Events

GentleWave

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EndoActivator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Bingham

Saint Louis University

Phone: 208-851-0618

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place