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NCT04966169 · ClinicalTrials.gov registry record · NA
Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study
A NA study, sponsored by University of Iowa.
- Terminated
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT04966169: Clinical Trial NA study, sponsored by University of Iowa.
NCT04966169 is a NA study that was terminated before completion, run by University of Iowa. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04966169, a NA study, was terminated before completion, sponsored by University of Iowa.
- TERMINATED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this 12-month prospective cohort study is to evaluate post-operatory pain, patient satisfaction, and treatment outcomes (i.e., healing) when the newly-developed, 510k FDA-approved multisonic energy GentleWAve System (Sonendo, Inc., Laguna Hills, CA) is used in complex root canal procedures.
Primary Outcome
This will be assessed by the evaluator measuring the estimated tooth on the CBCT and assigning an index score on the CBCT. A score of 0 denotes an intact periapical bone structure. A score of 1 denotes a diameter of periapical radiolucency \>0.5-1mm. A score of 2 denotes a diameter of periapical radiolucency \>1-2mm. A score of 3 denotes a diameter of periapical radiolucency \>2-4mm. A score of 4 denotes a diameter of periapical radiolucency \>4-8mm. A score of 5 denotes a diameter of periapical
Interventions
- DEVICE GentleWave System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-08-27 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
Why NCT04966169 stopped before completion
NCT04966169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which GentleWave System is the first listed.
NCT04966169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04966169 about?
NCT04966169 is a clinical study titled "Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study". The purpose of this 12-month prospective cohort study is to evaluate post-operatory pain, patient satisfaction, and treatment outcomes (i.e., healing) when the newly-developed, 510k FDA-approved multisonic energy GentleWAve System (Sonendo, Inc., Laguna Hills, CA) is used in complex root canal proce...
What is the current status of trial NCT04966169?
This trial is currently terminated. It is a NA study. The enrollment target is 23 participants. The study started on 2021-08-27. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT04966169?
The interventions under investigation include: GentleWave System (DEVICE).
Who is sponsoring clinical trial NCT04966169?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04966169's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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