GentleWave vs EdgePro for Infected Root Canals

Overseen By Ahmed Shehab-Eldin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Root fractures, Previous root canal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether GentleWave or EdgePro more effectively cleans infected root canals in teeth with pulp necrosis (dead tissue inside the tooth). Participants will receive one of these treatments to evaluate which best removes the infection. Individuals with permanent teeth requiring a root canal due to pulp necrosis may be suitable for this study. As an unphased trial, it offers a unique opportunity to contribute to dental research and potentially benefit from innovative treatment methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these irrigation techniques are safe for treating infected root canals?

Research has shown that the GentleWave system is generally safe for root canal treatments. Studies have found a high success rate of 97.3% for treatments using GentleWave, with post-procedure pain levels similar to traditional methods. Most patients tolerate the system well.

Similarly, the EdgePro laser system is effective and safe. It has been proven to clean and disinfect root canals effectively, removing up to 99% of bacteria. The EdgePro device has received FDA clearance, indicating it meets certain safety standards for dental procedures.

Both GentleWave and EdgePro are designed to enhance root canal cleaning and are considered safe options for patients. However, like any medical procedure, potential side effects may occur, so discussing these options with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for infected root canals because they offer innovative approaches compared to traditional methods like standard irrigation techniques. The GentleWave system uses a unique mechanism of action that applies advanced fluid dynamics to clean and disinfect the root canal more thoroughly and efficiently. Meanwhile, EdgePro Irrigation introduces a novel delivery method that aims to enhance debris removal and disinfection by using precise irrigation. These advancements could potentially lead to better treatment outcomes and faster recovery for patients.

What evidence suggests that this trial's treatments could be effective for infected root canals?

This trial will compare the GentleWave system and the EdgePro irrigation system for treating infected root canals. Studies have shown that the GentleWave system effectively cleans root canals, achieving a 97.3% success rate in endodontic treatments by removing bacteria and debris. Research indicates it reduces the risk of a failed root canal by preserving the tooth's structure without causing more pain than traditional methods.

The EdgePro irrigation system, another treatment arm in this trial, uses laser technology to clean and disinfect root canals. It can eliminate up to 99% of bacteria commonly found in root canals, effectively removing harmful germs and debris. Both systems show promise in treating infected root canals, each with its unique cleaning method. ^{1 2 4 6 7}

Who Is on the Research Team?

David Jaramillo, DDS

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals with dead tooth pulp in their permanent teeth, which often leads to infection. Participants should have this condition in at least one lower molar.

Inclusion Criteria

Signed informed consent.

I am chosen for a root canal treatment on a permanent tooth without surgery.

I have a dead nerve in one or more of my permanent teeth.

Exclusion Criteria

I have severe tooth damage.

My teeth are healthy and alive.

I have teeth with root fractures or have had a root canal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive irrigation treatment using GentleWave or EdgePro systems for disinfection of infected root canals

1-2 weeks

Follow-up

Participants are monitored for bacterial load reduction and treatment effectiveness after irrigation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EdgePro Irrigation
• GentleWave

Trial Overview The study aims to compare the effectiveness of two different cleaning systems, GentleWave and EdgePro laser irrigation, used during root canal treatments on infected molars with dead pulp tissue.

How Is the Trial Designed?

Group I: GentleWave Experimental Treatment 1 Intervention

Group II: EdgePro Experimental Treatment 1 Intervention

Group III: Irrisafe passive ultrasonic irrigation Active Control 1 Intervention

EdgePro Irrigation is already approved in United States for the following indications:

Approved in United States as EdgePRO for:

• Root canal disinfection and cleaning

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study involving 45 human teeth, both passive ultrasonic irrigation and manual dynamic irrigation significantly improved smear layer removal from root canals compared to no activation, indicating their efficacy in endodontic treatments.

Manual dynamic activation was found to be a simpler, safer, and more cost-effective method for smear layer removal compared to ultrasonic activation, making it a practical choice for dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of passive ultrasonic irrigation and manual dynamic irrigation on smear layer removal from root canals in a closed apex in vitro model. Andrabi, SM., Kumar, A., Zia, A., et al.[2014]

The GentleWave™ System generates negative apical pressures during root canal cleaning, which can enhance safety by reducing the risk of pushing debris beyond the root tip, unlike conventional syringe irrigation that produces positive pressures.

In a study involving extracted maxillary molars, the GentleWave™ System consistently created negative pressures between -13.07 and -17.19 mmHg, while syringe irrigation resulted in positive pressures ranging from 6.46 to 110.34 mmHg, indicating a significant difference in pressure dynamics during the irrigation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apical pressure created during irrigation with the GentleWave™ system compared to conventional syringe irrigation. Haapasalo, M., Shen, Y., Wang, Z., et al.[2022]

In a randomized clinical trial comparing the GentleWave System (GWS) to standard irrigation methods in endodontic treatment, both groups experienced similar rates of postoperative pain, with 72.2% in the standard group and 83.3% in the GWS group reporting pain.

Despite no significant difference in pain incidence or intensity between the two methods, both groups showed a statistically significant decrease in pain over time after treatment, indicating that pain generally lessens as time passes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial. Grigsby, D., Ordinola-Zapata, R., McClanahan, SB., et al.[2023]

The GentleWave System (GWS) demonstrated a significantly higher cleaning efficacy in root canals compared to conventional rotary instrumentation, achieving a 97.2% cleaning rate in certain canal regions versus 67.8% with traditional methods.

In a study involving 45 freshly extracted molars, the GWS effectively reduced residual debris in the mesiobuccal and mesiolingual canals, indicating its potential to improve endodontic treatment outcomes and reduce the risk of persistent infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Root Canal Debridement of Human Molars Using the GentleWave System. Molina, B., Glickman, G., Vandrangi, P., et al.[2017]

The GentleWave system (GW) demonstrated superior organic dissolution and bacterial reduction compared to conventional irrigation methods, making it an effective option for root canal treatments based on a review of 24 studies, including 4 clinical trials.

Clinically, the GW system achieved a high success rate of 97.3% in endodontic treatments, with postoperative pain levels comparable to traditional methods, indicating its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of the GentleWave system on root canal treatment: a narrative review. Coaguila-Llerena, H., Gaeta, E., Faria, G.[2022]

The GentleWave System (GWS) combined with either minimally invasive technique (MIT) or conventional instrumentation technique (CIT) was found to be the most effective in removing Enterococcus faecalis lipoteichoic acid (LTA) from infected root canals, with both methods showing similar efficacy.

In a study involving 60 extracted human teeth, GWS treatments resulted in more root canals having undetectable levels of E. faecalis LTA after treatment compared to other methods, highlighting its potential for improved infection control in endodontic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of GentleWave System and Passive Ultrasonic Irrigation with Minimally Invasive and Conventional Instrumentation Technique against Enterococcus faecalis Lipoteichoic Acid in Infected Root Canals. Velardi, JP., Alquria, TA., Alfirdous, RA., et al.[2022]

In a six-month clinical study involving 89 patients, the GentleWave® System demonstrated a high cumulative success rate of 97.4% for healing molars after root canal treatment.

Two key factors associated with successful healing were identified: the presence of apical periodontitis before treatment and the completion of the procedure in a single visit, highlighting the importance of these factors in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-month healing success rates after endodontic treatment using the novel GentleWave™ System: The pure prospective multi-center clinical study. Sigurdsson, A., Le, KT., Woo, SM., et al.[2020]

Citations

1. brasselerusadental.com brasselerusadental.com/edgeproendo

EdgePro Endodontic Laser Research has shown EdgePRO™ laser technology provides highly effective cleaning, debridement, and kills up to 99% of bacteria commonly found in the root canal.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/aej.70024?af=R

Efficacy of Supplementary Irrigation Methods Against ... This study evaluated the effectiveness of the GentleWave system (GWS), laser-activated irrigation (LAI), ultrasonic-activated irrigation ...

3. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/items/d3bc8bc1-620e-46d3-bed3-fa40c5241622

Bactericidal Efficacy of EdgePRO Er,Cr:YSGG Laser-Activated ... EdgePro LAI displayed statistically significant superior cleaning and disinfection of infected canal space compared to teeth treated with standard needle ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12244921/

The Influence of Laser-Assisted Irrigation on Root Canal ... Laser-assisted irrigation significantly enhances debris removal from root canals compared to conventional methods, especially in the coronal and middle thirds.

5. eastpointendodontics.com eastpointendodontics.com/what-is-the-edgepro-laser-for-endodontic-irrigation/

What is the EdgePro Laser for Endodontic irrigation? This laser system is used to enhance the cleaning and disinfection of root canals by using focused light energy to target and eliminate bacteria, biofilms, and ...

6. prnewswire.com prnewswire.com/news-releases/biolase-and-edgeendo-announce-fda-510k-clearance-of-new-edgepro-laser-assisted-microfluidic-irrigation-device-for-endodontists-301455329.html

BIOLASE and EdgeEndo Announce FDA 510(k) Clearance ... The new laser-assisted microfluidic irrigation device offers an advanced solution to current cleaning and disinfection techniques, without disrupting procedure ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06554366

Bacterial Load Reduction by GentleWave and EdgePro ... The purpose of this study is to compare the efficacy of GentleWave versus EdgePro irrigation in the disinfection of infected root canals of human permanent ...