NCT04552132|CompletedResultsFDA Device
Loading search results
Sponsor study identifier
interventional
63
1 country
1
Study Start
September 30, 2020
Actual (reported)Primary Completion
March 16, 2022
Actual (reported)Study Completion
March 16, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 16, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 13, 2020
Actual (reported)September 17, 2020
Actual (reported)September 30, 2020
Actual (reported)March 16, 2022
Actual (reported)March 16, 2022
Actual (reported)June 15, 2023
Actual (reported)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
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.
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 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.
Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Saint Louis University Center for Advanced Dental Education
St Louis, Missouri, 63104, United States
David Bingham, DDS
Resident at the Center for Advanced Dental Education
Brian Judd, DDS
Resident at the Center for Advanced Dental Education
63 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2020
First Posted
September 17, 2020
Study Start
September 30, 2020
Actual (reported)Intraoral Cryotherapy on Cytokine Levels and Postoperative Endodontic Pain
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
Contact the study team to confirm eligibility.
Primary Completion
March 16, 2022
Actual (reported)Study Completion
March 16, 2022
Actual (reported)Last Updated
June 15, 2023
Results First Posted
June 15, 2023
Record last verified: 2023-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: