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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the GentleWave system, a new technology for root canal treatment, in cleaning and treating teeth during procedures. Researchers will assess its effectiveness by examining results in real-life situations. Candidates for this trial include individuals who have opted for tooth extraction over other dental treatments. The study excludes teeth with fractures, previous root canal treatments, or severe damage. As an unphased trial, participants have the opportunity to contribute to innovative dental research and potentially benefit from cutting-edge technology.

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.

What prior data suggests that the GentleWave System is safe for root canal treatment?

Research shows that the GentleWave procedure is usually easy for patients to handle. Studies have found that it cleans root canals effectively without traditional dental tools, preserving the tooth's structure. However, like any medical procedure, it carries some risks. Certain health conditions or tooth shapes might make the procedure less suitable for some patients. While side effects can occur, they are uncommon. Patients should consult a dentist to determine if this procedure is appropriate for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GentleWave system for root canal treatment because it offers a unique approach compared to traditional methods. Unlike standard root canal treatments that rely on manual cleaning and mechanical instruments, GentleWave uses advanced fluid dynamics and acoustic energy to clean and disinfect the root canal system more thoroughly. This method aims to better reach complex areas within the tooth that are typically hard to clean, potentially leading to improved outcomes and less post-procedure discomfort. Additionally, the GentleWave system could reduce the time required for the procedure, making it a more efficient option for both patients and dental professionals.

What evidence suggests that the GentleWave System is effective for root canal treatment?

Research shows that the GentleWave system, which participants in this trial will receive, performs effectively for root canal treatments. Studies have found it successful in over 97% of cases, with most patients healing well and feeling better. High healing rates are reported at both 6 and 12 months after treatment, demonstrating its long-term effectiveness. Patients experience similar pain relief compared to other standard treatments. This new technology is designed to be less invasive, aiding in quick and comfortable recovery. Overall, GentleWave presents a promising option for those needing root canal therapy. ^{2 3 4 6 7}

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

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 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]

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 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 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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8891464/

Outcomes of the GentleWave system on root canal treatment Clinically, the success rate of endodontic treatment using GW was 97.3%, and the short-term postoperative pain in the GW group was not different from CSI.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0099239925006491

Clinical and Laboratory Insights into the GentleWave System Clinical trials reported high periapical healing rates, exceeding 97% at 6- and 12-month follow-ups, and postoperative pain levels comparable to ...

3. gentlewave.com gentlewave.com/

The GentleWave® Procedure: The Root Canal Treatment That ... Designed for patient comfort. Designed to be a minimally invasive treatment that offers improved outcomes2 and promotes pain-free fast healing2. 96.6% of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4930639/

Six-month healing success rates after endodontic treatment ... In this six-month PURE clinical study, the cumulative success rate of healing was 97.4% when patients were treated with the GentleWave® System.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0099239916301960

12-month Healing Rates after Endodontic Therapy Using ... Conclusions. In this 12-month prospective multicenter clinical study, the GentleWave System showed a high level of success after a 12-month follow-up.

6. gentlewave.com gentlewave.com/safety-information

Safety Information | GentleWave Procedure The GentleWave System may be contraindicated for patients with other health conditions or specific tooth anatomy and known sensitivities to certain materials or ...

7. gentleendo.com gentleendo.com/procedures/gentlewave-ultracleaning/

GentleWave UltraCleaning Medina OH | Root Canal The GentleWave Procedure is an innovative alternative to standard root canal treatment that uses a powerful combination of procedure fluids and energy.