Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator

Not Applicable

Completed

Conditions: Apical Periodontitis
Symptomatic Irreversible Pulpitis

Interventions: Device: Multisonic vs Sonic activation of irrigants

Registration Number: NCT04552132

Lead Sponsor: St. Louis University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EndoActivator	Multisonic vs Sonic activation of irrigants	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.
GentleWave	Multisonic vs Sonic activation of irrigants	Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.

Primary Outcome Measures

Name	Time	Method
72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021	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).
96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021	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).
48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022	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).
72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022	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).
Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report	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.
24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021	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).
24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022	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).
48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021	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).
Cone Beam Computed Tomography (CBCT) Healing Assessment	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.
96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022	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).

Secondary Outcome Measures

Name	Time	Method
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.	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	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.