Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552132
• Other study ID #: 31359
• Status: Completed
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: March 16, 2022

Study information

• Verified date: May 2023
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis
• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Device:
• Multisonic vs Sonic activation of irrigants
Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.

Locations

Country	Name	City	State
United States	Saint Louis University Center for Advanced Dental Education	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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.