N/A
N=87
Occurrence of Post-op Pain Following Gentlewave
Root Canal Infection · Endodontic Disease · Endodontic Inflammation · Post-Operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT03635515 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Level of Post-operative Pain (2018-2019) — 23.2; 11.56 score on VAS scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gentlewave (Device); Standard Endodontic Protocol (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Post-operative Pain (2018-2019) |
5.22; 2.78 | — |
| PRIMARY Level of Post-operative Pain (2018-2019) |
5.22; 2.78 | — |
| PRIMARY Level of Post-operative Pain (2018-2019) |
5.22; 2.78 | — |
| PRIMARY Level of Post-operative Pain (2018-2019) |
5.22; 2.78 | — |
| PRIMARY Level of Post-operative Pain (2020-2021) |
8; 6 | — |
| PRIMARY Level of Post-operative Pain (2020-2021) |
8; 6 | — |
| PRIMARY Level of Post-operative Pain (2020-2021) |
8; 6 | — |
| PRIMARY Level of Post-operative Pain (2020-2021) |
8; 6 | — |
Summary
This is a clinical study that will investigate the occurrence of post-operative discomfort following the use of the Gentlewave System for root canal disinfection and irrigation. Assessment of discomfort level will be via a visualized analog pain scale.
Eligibility Criteria
Inclusion Criteria
- The target population of the study includes patients needing endodontic treatment in the University of Minnesota Graduate Endodontics clinic, ages 18+. Vulnerable populations that will be included in the study are members of the military and those individuals from an undervalued or disenfranchised social group.
Exclusion Criteria
- Patients with teeth that have root apices in the maxillary sinus, teeth with immature root apices, and teeth with insufficient coronal tooth structure will be excluded. For the purposes of this study children, pregnant women, prisoners, and adults lacking the capacity to consent will be excluded.
Data sourced from ClinicalTrials.gov (NCT03635515). 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.