Disinfection Technologies for Tooth Abscess

CW
AF
Overseen ByAshraf F Fouad, DDS, MS
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods for cleaning and disinfecting root canals in molars with persistent tooth abscesses after initial treatment. One group will use the GentleWave System, a new technology that employs sound waves and fluid dynamics for more thorough cleaning. The other group will use a conventional method with rotary instrumentation and passive ultrasonic irrigation, involving tools and a special cleaning solution. The study will assess the remaining bacteria, any leftover debris, and the level of pain patients experience afterward. This trial suits individuals with molar abscesses larger than 3 mm who underwent root canal therapy over a year ago, excluding those with severe gum issues or recent antibiotic use. As an unphased trial, this study provides a unique opportunity to explore innovative dental treatments and contribute to advancing dental care.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on antibiotics, you must not have taken them in the last 3 months to be eligible.

What prior data suggests that these disinfection technologies are safe for root canal treatment?

Research has shown that the GentleWave System is generally well-tolerated by patients. Clinical studies report a high success rate of 97.3% in treating root canal problems, indicating that most patients experience positive outcomes. Pain levels after using GentleWave are similar to those with standard treatments, so patients do not experience increased pain.

Studies suggest that traditional rotary tools with ultrasonic cleaning also effectively reduce bacteria in the root canal. However, regular use does not always result in better overall treatment success compared to other methods.

Both treatments appear safe based on current data, with no increased risk of side effects compared to other common dental treatments.12345

Why are researchers excited about this trial?

Researchers are excited about these disinfection technologies for tooth abscesses because they offer innovative approaches to root canal retreatment. The GentleWave System uses advanced fluid dynamics to clean and disinfect the root canal system with minimal mechanical instrumentation, potentially reducing the risk of damaging the tooth structure. This contrasts with conventional methods that rely heavily on nickel-titanium rotary tools and ultrasonic irrigation. The GentleWave System's precision may lead to better removal of bacteria and organic debris, which could enhance healing and reduce postoperative pain. By comparing these two methods, researchers aim to determine which technique is more effective in improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for tooth abscess?

Research has shown that the GentleWave System, which participants in this trial may receive, achieves about 97.3% success in root canal treatments in past studies. Patients using GentleWave experienced similar short-term pain levels as with other methods. This system effectively cleans by using advanced techniques to target bacteria and debris. In comparison, another treatment option in this trial involves traditional methods like rotary tools with passive ultrasonic irrigation (PUI), which also effectively reduce bacteria and harmful chemicals. PUI enhances cleaning by using sound waves. Both treatments work well, but GentleWave might clean better and preserve more of the tooth.16789

Who Is on the Research Team?

CW

Can Wang, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for people age 16 and older who need a repeat root canal on a molar with an infection at the tip of the root (apical periodontitis) seen on X-rays. Participants must be able to consent in English, have no major health issues like uncontrolled diabetes or immune problems, and meet specific dental criteria ensuring retreatment is possible.

Inclusion Criteria

My dental exam shows retreatment is possible and safe for my tooth.
Patients who are able to read and consent in English
Molars showing radiographic evidence of post-treatment apical periodontitis: a lesion that exceeds 3 mm in diameter on one or more roots
See 2 more

Exclusion Criteria

My tooth needing retreatment has roots or a lesion reaching into my maxillary sinus.
I need a root canal retreatment and have gum pockets deeper than 5mm.
I need a root canal retreatment on a tooth close to my mandibular canal.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo root canal disinfection using either the GentleWave System or conventional rotary instrumentation with passive ultrasonic irrigation. Microbiological samples are collected before and after treatment to evaluate intracanal bacterial load and microbiome composition.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for postoperative pain and other clinical outcomes. Pain levels are recorded using a numerical rating scale over several days following the treatment.

1 week
No additional visits required, follow-up via pain diary

What Are the Treatments Tested in This Trial?

Interventions

  • Conventional rotary instrumentation with passive ultrasonic irrigation
  • GentleWave System

Trial Overview

The study compares two ways to disinfect molars during non-surgical root canal retreatment: traditional rotary tools with ultrasonic cleaning versus the GentleWave System, which uses advanced fluid technology. Patients are randomly assigned to one method, and outcomes like bacterial removal and pain are measured.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: GentleWave Disinfection GroupActive Control1 Intervention
Group II: Conventional Rotary Instrumentation with Passive Ultrasonic IrrigationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Comparative Evaluation of the Effectiveness of Rotary ... - PMC

The aim of this study was to compare the effectiveness of rotary instrumentation over manual instrumentation with ultrasonic irrigation on incidence, duration, ...

Outcomes of Endodontic Therapy Comparing Conventional ...

The aim of the present study was to investigate the clinical outcomes of two different standardized endodontic irrigation protocols.

Influence of Ultrasonic Activation of Endodontic Irrigants on ...

Ultrasonic irrigation was associated with improved clinical outcomes, particularly greater reductions in bacterial load and endotoxins; however, findings ...

Efficacy of Different Disinfection Technologies in Molar Non ...

Conventional retreatment protocols typically involve nickel-titanium rotary instrumentation combined with irrigation using sodium hypochlorite and activation ...

The effectiveness of passive ultrasonic irrigation and the...

This study aimed to evaluate the efficacy of passive ultrasonic irrigation (PUI) and the easy clean instrument by micro-computed tomography (CT) for removing ...

SYSTEMATIC REVIEW

Conclusion: It may be concluded that mechanical active irrigation devices are beneficial in reducing post- operative pain and improving canal ...

Passive Ultrasonic Irrigation in Endodontics

An irrigation technique called conventional needle irrigation has been in use since decades, but the problems with it are its low penetration ...

Evaluation of the Efficacy of Passive Ultrasonic Irrigation ...

Current evidence does not support the routine use of passive ultrasonic irrigation to improve the clinical success of endodontic therapy.

Effect of Passive Ultrasonic Irrigation on Success ...

Curtis et al found that continuous ultrasonic irrigation resulted in significantly less debris present in root canals at 1 and 3 mm from the working length as ...