GentleWave System for Apical Periodontitis

Overseen By Fabricio Teixeira, DDS,MS,PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Must not be taking: Corticosteroids

Disqualifiers: Pregnancy, Advanced periodontal disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called the GentleWave System for root canal treatments. It evaluates patient recovery, post-procedure pain, and treatment satisfaction. The trial targets individuals with apical periodontitis, an infection of the tissue around a tooth's root end. Candidates with a back molar unresponsive to cold or electric tests may qualify. Participants must attend follow-up visits six months and one year after treatment. As an unphased trial, this study provides a unique opportunity to contribute to advancements in dental care.

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

The trial does not specify if you need to stop taking your current medications, but it does exclude people taking corticosteroids.

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

Research has shown that the GentleWave System is generally safe for root canal treatments. One study reported that 97.3% of patients experienced successful results, with short-term pain comparable to traditional methods. Another study found a 97.4% success rate in healing over six months. The FDA has approved this system, indicating it meets safety standards for dental procedures. Overall, the GentleWave System appears well-tolerated, with no special safety concerns noted in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GentleWave System is unique because it uses advanced fluid dynamics and acoustic energy to clean and disinfect root canals more thoroughly than standard treatments. Traditional root canal therapy typically involves manual instruments and chemical solutions, but the GentleWave System enhances cleaning by reaching microscopic spaces within the tooth that are often missed. This precision and efficiency can potentially reduce the time needed for treatment and improve overall outcomes, which is why researchers are excited about its potential to transform endodontic care.

What evidence suggests that the GentleWave System is effective for apical periodontitis?

Research has shown that the GentleWave System is highly effective for root canal treatments. One study found a 97.3% success rate in these treatments, while another reported a 97.4% success rate in healing within six months. The system reduces post-treatment pain and lowers the likelihood of needing the procedure again. It performs well even in challenging cases, such as those involving dead tissue or severe tooth inflammation. This evidence suggests that the GentleWave System is a reliable choice for addressing complex root canal issues. ^{1 2 3 6 7}

Who Is on the Research Team?

Fabricio Teixeira, DDS,MS,PhD

Principal Investigator

University of Iowa College of Dentistry

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can read and speak English, have specific types of molars with a diagnosis of pulp necrosis and apical periodontitis, and can attend follow-ups. It's not for those with untreated gum disease, poor dental visit attendance, or students/trainees linked to the research team.

Inclusion Criteria

Current radiograph available (or done at screening, as needed)

My tooth problem is with a lower back molar.

My dental scan shows I have root tip inflammation.

Exclusion Criteria

My tooth has had previous treatment like cleaning out the pulp.

I experience facial pain not related to my teeth.

Supervised by the Principal Investigator or a member of the research team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive root canal therapy using the Sonendo GentleWave System

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits at 2 days, 1 week, 2 weeks, 6 months, and 12 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• GentleWave System

Trial Overview

The study tests the GentleWave System in root canal treatments over a year. It focuses on pain after surgery, patient satisfaction, and how well the treatment heals infected root canals compared to traditional methods.

How Is the Trial Designed?

Group I: Sonendo GentleWave Experimental Treatment 1 Intervention

Every participant will receive the same experimental treatment, which is root canal therapy using the Sonendo GentleWave System.

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Published Research Related to This Trial

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 (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 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]

During a study analyzing dental device adverse events from August 1996 to June 1999, 28,555 reports (10.5% of total) were related to dental devices, with the majority involving injuries (64.4%) and a small number of deaths (0.007%).

Endosseous implants were the most frequently reported dental devices, accounting for over 90% of the reports, highlighting the importance of monitoring these devices for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental device-associated problems: an analysis of FDA postmarket surveillance data. Fuller, J., Parmentier, C.[2019]

The GentleWave System was found to be significantly more effective at reducing biofilm in the roots of molars compared to conventional rotary instrumentation combined with passive ultrasonic activation, with a notable difference in both apical and middle regions of the roots (p = 0.001).

In the study involving 47 human molars inoculated with Enterococcus faecalis, the GentleWave System showed a significant reduction in biofilm presence compared to untreated controls (p = 0.003), indicating its potential as a superior disinfection method in endodontic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Analysis of Biofilm Removal Efficacy by Multisonic Ultracleaning System and Passive Ultrasonic Activation. Choi, HW., Park, SY., Kang, MK., 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]

From 1996 to 2011, there were 28,046 adverse event reports related to dental devices in the MAUDE database, with 53.5% of these reports concerning endosseous implants, highlighting a significant area of concern in dental device safety.

Among the reported adverse events, there were 66 death reports associated with dental devices, although many lacked sufficient information to confirm the circumstances, indicating a need for better reporting and monitoring systems in dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database. Hebballi, NB., Ramoni, R., Kalenderian, E., et al.[2021]

A review of 384 reports on the PEAK PlasmaBlade 3.0 and 4.0 revealed that 82.1% of adverse events were due to device malfunctions, with the most common issues being delaminated coating and ignition or fire.

While the device is useful in surgeries, it has been linked to patient and operator injuries, highlighting the need for better education on its risks and standardized reporting protocols to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE. Lee, E., Elzomor, A., Boulos, S., 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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04966169

Effectiveness of GentleWave on the Healing of Apical ...

The purpose of this 12-month prospective cohort study is to evaluate post-operatory pain, patient satisfaction, and treatment outcomes (i.e., healing) when ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0099239925006491

Clinical and Laboratory Insights into the GentleWave System

The GentleWave® System achieved a 97.4% healing success rate over six months. Sigurdsson et al., 2016, Journal of Endodontics, Prospective ...

4.

gentlewave.com

gentlewave.com/doctor/why-gentlewave

Why GentleWave®

The GentleWave System limits post-treatment pain 1 , minimizes retreatment 2 and enables outstanding healing, even in necrotic and irreversible pulpitis.

5.

jendodon.com

jendodon.com/article/S0099-2399(25)00192-X/fulltext

Healing Outcomes Following the Treatment of Molars ...

The GentleWave system and the combination of ultrasonics and negative pressure showed comparable effectiveness in promoting the healing of ...

6.

gentlewave.com

gentlewave.com/doctor/clinical-evidence/two-year-radiographic-and-clinical-results-sonendo-gentlewave-cleanflow

Two-Year Radiographic and Clinical Results with ...

The GentleWave Procedure using the CleanFlow Procedure Instrument combined with minimal instrumentation led to 71 of the 74 teeth (96%) successfully treated ...

7.

gentlewave.com

gentlewave.com/doctor/sites/default/files/2024-11/GentleWave_System_Clinical_Research_Brochure%20-MM-2174_Rev_02%5B14%5D.pdf

The GentleWave® System

A total of 24 studies (20 in vitro and 4 clinical) were reviewed and described the following outcomes: the GentleWave System had a clinical endodontic success ...