GentleWave for Root Canal Treatment

Overseen By Sandra Jung

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Root fractures, Previous root canal, Children

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of GentleWave, a new dental cleaning technology, on patients needing tooth cleaning and disinfection. GentleWave uses fluids and sound waves to clean areas inside the tooth more thoroughly than traditional methods. The GentleWave System has been shown to result in a higher tissue dissolution rate and effective cleaning compared to traditional methods.

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

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

Is the GentleWave System safe for root canal treatment?

The GentleWave System has been evaluated in clinical studies, and it is considered a nonsignificant risk treatment, meaning it is generally safe for use in humans. ^{1 2 3 4 5}

How is the GentleWave treatment different from other root canal treatments?

The GentleWave treatment is unique because it uses a combination of high-velocity irrigants and multisonic sound waves to clean root canals more effectively than traditional methods, which typically rely on needle irrigation and sonic activation. This approach can lead to better cleaning, potentially reducing infection and improving healing rates. ^{2 3 4 5 6}

What data supports the effectiveness of the GentleWave treatment for root canal procedures?

Research shows that the GentleWave System is more effective at cleaning root canals compared to traditional methods, leading to higher tissue dissolution rates and better removal of infection-causing substances. Additionally, studies indicate that it may reduce postoperative pain and improve healing success rates after treatment. ^{2 3 4 5 6}

Who Is on the Research Team?

David E Jaramillo, DDS

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults who have chosen to have a tooth extracted rather than undergo other dental treatments. It's not suitable for teeth with severe structural damage, root fractures, or those that previously had root canal treatment.

Inclusion Criteria

Only teeth that patient decided to have the extraction done instead of having any other type of dental treatment and teeth extracted at patient's petition.

Exclusion Criteria

You have severe damage to your teeth.

You have teeth with fractures in the roots or that have had root canal treatment before.

Participants must be adults and not children.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo partial root canal treatment with the Sonendo GentleWave

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for histological evaluation of pulp tissue after treatment

Immediate

What Are the Treatments Tested in This Trial?

Interventions

• GentleWave

Trial Overview The study is testing the effectiveness of GentleWave technology in cleaning and disinfecting the hard-to-reach areas during a root canal procedure on mandibular molars, using actual human cases.

How Is the Trial Designed?

Group I: Partial root canal treatment with the Sonendo GentleWave Experimental Treatment 1 Intervention

GentleWave is already approved in United States, Canada, European Union for the following indications:

Approved in United States as GentleWave Procedure for:

• Root canal treatment
• Pulp tissue debridement and disinfection

Approved in Canada as GentleWave Procedure for:

• Root canal treatment
• Pulp tissue debridement and disinfection

Approved in European Union as GentleWave Procedure for:

• Root canal treatment
• Pulp tissue debridement and disinfection

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Sonendo, Inc.

Industry Sponsor

Trials

4

Recruited

640+

Published Research Related to This Trial

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 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]

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 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]

In a study involving 89 patients, the GentleWave System demonstrated a high cumulative success rate of 97.3% for healing molars after endodontic therapy over a 12-month period.

The system was particularly effective for treating irreversible pulpitis, achieving a success rate of 98.4%, and only 3.8% of patients reported moderate postoperative pain, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

12-month Healing Rates after Endodontic Therapy Using the Novel GentleWave System: A Prospective Multicenter Clinical Study. Sigurdsson, A., Garland, RW., Le, KT., et al.[2022]

Citations

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

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

2. 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]

3. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

5. 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]

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

12-month Healing Rates after Endodontic Therapy Using the Novel GentleWave System: A Prospective Multicenter Clinical Study. [2022]