NCT04552132

Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator

Completed NA Results posted Last updated 15 June 2023

What this trial tests

NA trial testing Multisonic vs Sonic activation of irrigants in Symptomatic Irreversible Pulpitis in 63 participants. Completed in 16 March 2022.

Timeline

30 September 2020

Primary endpoint
16 March 2022

16 March 2022

Quick facts

Lead sponsor	St. Louis University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	63
Start date	30 September 2020
Primary completion	16 March 2022
Estimated completion	16 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Multisonic vs Sonic activation of irrigants

Conditions studied

• Symptomatic Irreversible Pulpitis — all drugs for Symptomatic Irreversible Pulpitis →
• Apical Periodontitis — all drugs for Apical Periodontitis →

Sponsor

St. Louis University

Who can join

18 and older, any sex, with Symptomatic Irreversible Pulpitis or Apical Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 Primary · 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).

Group	Value	95% CI
GentleWave	14.75	± 17.91
EndoActivator	16.23	± 27.93

24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 Primary · 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).

Group	Value	95% CI
GentleWave	12.86	± 18.65
EndoActivator	17.00	± 18.69

48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 Primary · 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).

Group	Value	95% CI
GentleWave	12.58	± 18.71
EndoActivator	11.73	± 19.58

48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 Primary · 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).

Group	Value	95% CI
GentleWave	6.86	± 12.35
EndoActivator	10.07	± 11.49

72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 Primary · 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).

Group	Value	95% CI
GentleWave	7.46	± 14.36
EndoActivator	7.30	± 13.14

72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 Primary · 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).

Group	Value	95% CI
GentleWave	3.57	± 4.89
EndoActivator	5.86	± 10.85

96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 Primary · 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).

Group	Value	95% CI
GentleWave	9.96	± 19.98
EndoActivator	7.53	± 16.15

96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 Primary · 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).

Group	Value	95% CI
GentleWave	1.57	± 3.61
EndoActivator	2.57	± 3.63

Cone Beam Computed Tomography (CBCT) Healing Assessment Primary · 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.

Healed

Group	Value	95% CI
GentleWave	24
EndoActivator	24

Healing

Group	Value	95% CI
GentleWave	4
EndoActivator	4

Diseased

Group	Value	95% CI
GentleWave	0
EndoActivator	4

Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report Primary · 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.

Success

Group	Value	95% CI
GentleWave	12
EndoActivator	12

Failure

Group	Value	95% CI
GentleWave	0
EndoActivator	2

Pain Pill Consumption for Patients Seen From 09/2021-06/2021 Secondary · 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.

Group	Value	95% CI
GentleWave	5.08	± 4.56
EndoActivator	6.63	± 7.63

Pain Pill Consumption for Patients Seen From 07/2021-03/2022 Secondary · 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.

Group	Value	95% CI
GentleWave	4.00	± 3.82
EndoActivator	4.93	± 8.02

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.