Back to resultsPostoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator
Primary Purpose
Symptomatic Irreversible Pulpitis, Apical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multisonic vs Sonic activation of irrigants
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Irreversible Pulpitis
Eligibility Criteria
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
Sites / Locations
- Saint Louis University Center for Advanced Dental Education
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GentleWave
EndoActivator
Arm Description
Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.
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.
Outcomes
Primary Outcome Measures
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 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 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 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 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 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 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 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).
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04552132
Brief Title
Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator
Official Title
Postoperative Pain and Healing of Molar Root Canal Teeth Using GentleWave vs. EndoActivator
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis, Apical Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GentleWave
Arm Type
Experimental
Arm Description
Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.
Arm Title
EndoActivator
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Multisonic vs Sonic activation of irrigants
Intervention Description
Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.
Primary Outcome Measure Information:
Title
24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Description
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
Title
24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Description
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
Title
48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Description
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
Title
48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Description
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
Title
72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Description
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
Title
72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Description
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
Title
96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Description
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
Title
96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Description
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
Title
Cone Beam Computed Tomography (CBCT) Healing Assessment
Description
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
Title
Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report
Description
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
Secondary Outcome Measure Information:
Title
Pain Pill Consumption for Patients Seen From 09/2021-06/2021
Description
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.
Title
Pain Pill Consumption for Patients Seen From 07/2021-03/2022
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Bingham, DDS
Organizational Affiliation
Resident at the Center for Advanced Dental Education
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Judd, DDS
Organizational Affiliation
Resident at the Center for Advanced Dental Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University Center for Advanced Dental Education
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator
We'll reach out to this number within 24 hrs