CompletedNot Applicable

Occurrence of Post-op Pain Following Gentlewave

United States87 participantsStarted 2018-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Level of Post-operative Pain (2018-2019)

Timeframe: 6 hours

Level of Post-operative Pain (2018-2019)

Timeframe: 24 hours

Level of Post-operative Pain (2018-2019)

Timeframe: 72 hours

Level of Post-operative Pain (2018-2019)

Timeframe: 168 hours

Level of Post-operative Pain (2020-2021)

Timeframe: 6 hours

Level of Post-operative Pain (2020-2021)

Timeframe: 24 hours

Level of Post-operative Pain (2020-2021)

Timeframe: 72 hours

Level of Post-operative Pain (2020-2021)

Timeframe: 168 hours

Trial details

NCT IDNCT03635515

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

Results submitted2022-08-17

View on ClinicalTrials.gov More Root Canal Infection trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Level of Post-operative Pain (2018-2019)

Timeframe: 6 hours

Level of Post-operative Pain (2018-2019)

Timeframe: 24 hours

Level of Post-operative Pain (2018-2019)

Timeframe: 72 hours

Level of Post-operative Pain (2018-2019)

Timeframe: 168 hours

Level of Post-operative Pain (2020-2021)

Timeframe: 6 hours

Level of Post-operative Pain (2020-2021)

Timeframe: 24 hours

Level of Post-operative Pain (2020-2021)

Timeframe: 72 hours

Level of Post-operative Pain (2020-2021)

Timeframe: 168 hours