Clinical trial NCT04552132: 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
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Apical Periodontitis
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
timeFrame: 24 hours post-operative
measure: 24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
timeFrame: 24 hr postoperatively
measure: 48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
timeFrame: 48 hours post-operative
measure: 48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
timeFrame: 48 hours post-operative
measure: 72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
timeFrame: 72 hour post-operative
measure: 72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
timeFrame: 72 hours post-operative
measure: 96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
timeFrame: 96 hours post-operative
measure: 96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
timeFrame: 96 hours post-operative
measure: Cone Beam Computed Tomography (CBCT) Healing Assessment
timeFrame: 12 month recall
measure: Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report
timeFrame: 12-month recall
Secondary outcomes:
measure: Pain Pill Consumption for Patients Seen From 09/2021-06/2021
timeFrame: 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.
measure: Pain Pill Consumption for Patients Seen From 07/2021-03/2022
timeFrame: 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.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University Center for Advanced Dental Education
state: Missouri
Study officials:
affiliation: Resident at the Center for Advanced Dental Education
name: David Bingham, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Resident at the Center for Advanced Dental Education
name: Brian Judd, DDS
role: PRINCIPAL_INVESTIGATOR
References: