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

Trial Summary

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 data supports the effectiveness of the GentleWave treatment for infected root canals?

Research shows that the GentleWave System is effective in cleaning root canals by removing more bacteria and tissue debris compared to traditional methods. It also has a high success rate of 97.3% in endodontic treatments and does not increase postoperative pain compared to standard treatments. ^{1 2 3 4 5}

Is the GentleWave System safe for use in root canal treatments?

The GentleWave System has been studied in clinical trials and reviews, showing no significant difference in short-term postoperative pain compared to traditional methods, and no association with harmful irrigant extrusion, suggesting it is generally safe for use in root canal treatments. ^{1 2 3 4 6}

How is the GentleWave treatment different from other treatments for infected root canals?

The GentleWave treatment is unique because it uses a combination of high-velocity irrigants and multisonic activation to clean root canals more effectively than traditional methods, which often rely on conventional needle irrigation. This approach results in better removal of bacteria and tissue debris, potentially leading to higher success rates in root canal treatments. ^{1 2 3 4 7}

What is the purpose of this trial?

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 teeth with necrotic pulp.

Research Team

David Jaramillo, DDS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Signed informed consent.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Root Canal Debridement of Human Molars Using the GentleWave System. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial. [2023]

3. United States 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. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Outcomes of the GentleWave system on root canal treatment: a narrative review. [2022]

5. Australia 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. [2014]

6. Spain 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. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Apical pressure created during irrigation with the GentleWave™ system compared to conventional syringe irrigation. [2022]