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NCT07469150 · ClinicalTrials.gov registry record · NA
Efficacy of Different Disinfection Technologies in Molar Non-Surgical Retreatment
A NA study, sponsored by University of Alabama at Birmingham.
- Not yet
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT07469150: Clinical Trial NA study, sponsored by University of Alabama at Birmingham.
NCT07469150 is a NA study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07469150, a NA study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
Post-treatment apical periodontitis is commonly associated with persistent intracanal infection following root canal treatment. Effective disinfection of the complex root canal system during nonsurgical retreatment remains challenging due to anatomical complexities that may harbor microbial biofilms. Conventional retreatment protocols typically involve nickel-titanium rotary instrumentation combined with irrigation using sodium hypochlorite and activation techniques such as Passive Ultrasonic Irrigation (PUI). The GentleWave System (GWS) is a minimally invasive irrigation technology designed to enhance tissue dissolution and microbial removal through multisonic energy, advanced fluid dynamics, and negative pressure. Although preliminary studies suggest promising results in root canal disinfection and patient outcomes, high-level clinical evidence comparing GWS with conventional retreatment techniques remains limited, particularly in molar teeth with post-treatment apical periodontitis. This randomized clinical study aims to compare the disinfection efficacy of GWS with a conventional nickel-titanium rotary instrumentation protocol combined with PUI in nonsurgical retreatment of molars with post-treatment apical periodontitis. Intracanal bacterial load will be quantified using quantitative polymerase chain reaction (qPCR), and microbial composition will be analyzed using next-generation sequencing (NGS). Residual organic debris will be evaluated using the chairside diagnostic device Endocator and facultative bacterial culturing. Postoperative pain levels will also be recorded to assess short-term clinical outcomes. The results of this study will provide clinical evidence regarding the comparative effectiveness, safety, and potential advantages of advanced irrigation technology for root canal disinfection in complex retreatment cases.
Primary Outcome
Change in total bacterial load in the root canal system following disinfection, measured by quantitative real-time polymerase chain reaction (qPCR) targeting the universal 16S rRNA gene. Bacterial load will be quantified from microbiological samples collected before instrumentation (S1) and after completion of the disinfection protocol (S2) to determine the reduction in bacterial load between the two time points.
Interventions
- PROCEDURE GentleWave System
- PROCEDURE Conventional rotary instrumentation with passive ultrasonic irrigation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2027-07 |
| Est. Completion | 2030-12 |
| Phase | NA |
What is known before NCT07469150 opens enrollment
NCT07469150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which GentleWave System is the first listed.
NCT07469150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07469150 about?
NCT07469150 is a clinical study titled "Efficacy of Different Disinfection Technologies in Molar Non-Surgical Retreatment". Post-treatment apical periodontitis is commonly associated with persistent intracanal infection following root canal treatment. Effective disinfection of the complex root canal system during nonsurgical retreatment remains challenging due to anatomical complexities that may harbor microbial biofilms...
What is the current status of trial NCT07469150?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2027-07. Estimated completion is 2030-12.
What interventions are being tested in trial NCT07469150?
The interventions under investigation include: GentleWave System (PROCEDURE), Conventional rotary instrumentation with passive ultrasonic irrigation (PROCEDURE).
Who is sponsoring clinical trial NCT07469150?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07469150's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 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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