N/A
N=63
Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator
Symptomatic Irreversible Pulpitis · Apical Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT04552132 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 — 14.75; 16.23 score on a scale — p=0.63
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multisonic vs Sonic activation of irrigants (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Louis University
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 |
14.75; 16.23 | 0.63 |
| PRIMARY 24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 |
12.86; 17.00 | 1.00 |
| PRIMARY 48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 |
12.58; 11.73 | 0.63 |
| PRIMARY 48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 |
6.86; 10.07 | 1.00 |
| PRIMARY 72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 |
7.46; 7.30 | 0.57 |
| PRIMARY 72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 |
3.57; 5.86 | 0.60 |
| PRIMARY 96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 |
9.96; 7.53 | 1.00 |
| PRIMARY 96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022 |
1.57; 2.57 | 1.00 |
| PRIMARY Cone Beam Computed Tomography (CBCT) Healing Assessment |
24; 24; 4; 4; 0; 4 | 0.18 |
| PRIMARY Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report |
12; 12; 0; 2 | .4993 |
| SECONDARY Pain Pill Consumption for Patients Seen From 09/2021-06/2021 |
5.08; 6.63 | 0.52 |
| SECONDARY Pain Pill Consumption for Patients Seen From 07/2021-03/2022 |
4.00; 4.93 | .70 |
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
Data sourced from ClinicalTrials.gov (NCT04552132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.