Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator

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

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.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis; Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Device: Multisonic vs Sonic activation of irrigants

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University Center for Advanced Dental Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GentleWave; 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; Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.
Active Comparator: 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.	Device: Multisonic vs Sonic activation of irrigants; Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: David Bingham, DDS, Resident at the Center for Advanced Dental Education; Principal Investigator: Brian Judd, DDS, Resident at the Center for Advanced Dental Education

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Dental Pulp Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Pulpitis; Periapical Periodontitis
• Other Study ID Numbers: 31359

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes