18 and older, any sex, with Root Canal Infection or Endodontic Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Level of Post-operative Pain (2018-2019)Primary· 6 hours
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale.
Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Group
Value
95% CI
Standard Protocol (Control) Group
23.2
± 25.38
Gentlewave Treatment Group
11.56
± 9.94
Level of Post-operative Pain (2018-2019)Primary· 24 hours
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale.
Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Group
Value
95% CI
Standard Protocol (Control) Group
19.33
± 21.46
Gentlewave Treatment Group
7.78
± 10.88
Level of Post-operative Pain (2018-2019)Primary· 72 hours
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale.
Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Group
Value
95% CI
Standard Protocol (Control) Group
13.11
± 18.56
Gentlewave Treatment Group
5
± 7.28
Level of Post-operative Pain (2018-2019)Primary· 168 hours
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale.
Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Group
Value
95% CI
Standard Protocol (Control) Group
5.22
± 10.46
Gentlewave Treatment Group
2.78
± 7.32
Level of Post-operative Pain (2020-2021)Primary· 6 hours
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale.
Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Group
Value
95% CI
Standard Protocol (Control) Group
22
13 – 30
Gentlewave Treatment Group
24
15 – 33
Level of Post-operative Pain (2020-2021)Primary· 24 hours
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale.
Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Group
Value
95% CI
Standard Protocol (Control) Group
25
16 – 34
Gentlewave Treatment Group
21
12 – 30
Level of Post-operative Pain (2020-2021)Primary· 72 hours
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale.
Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Group
Value
95% CI
Standard Protocol (Control) Group
17
9 – 26
Gentlewave Treatment Group
15
6 – 23
Level of Post-operative Pain (2020-2021)Primary· 168 hours
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale.
Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Group
Value
95% CI
Standard Protocol (Control) Group
8
0 – 16
Gentlewave Treatment Group
6
0 – 14
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
Last refreshed: 15 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03635515.