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

23 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this 12-month prospective cohort study is to evaluate post-operatory pain, patient satisfaction, and treatment outcomes (i.e., healing) when the newly-developed, 510k FDA-approved multisonic energy GentleWAve System (Sonendo, Inc., Laguna Hills, CA) is used in complex root canal procedures.

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 data supports the effectiveness of the GentleWave System treatment for apical periodontitis?

Research shows that the GentleWave System is effective in cleaning root canals and removing biofilm, which are key to successful healing after root canal treatments. Studies found it to be more effective than traditional methods in reducing biofilm and improving healing rates in molars. ^{1 2 3 4 5}

Is the GentleWave System safe for use in humans?

There is no specific safety data available for the GentleWave System in the provided research articles. ^{6 7 8 9 10}

How does the GentleWave System treatment differ from other treatments for apical periodontitis?

The GentleWave System is unique because it uses high-velocity degassed irrigants and broad-spectrum sound energy to clean root canals more effectively than traditional methods, resulting in better removal of biofilm and higher tissue dissolution rates. ^{1 2 3 5 11}

Research Team

Fabricio Teixeira, DDS,MS,PhD

Principal Investigator

University of Iowa College of Dentistry

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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. 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]

2. 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]

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

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

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

Effectiveness of the GentleWave System in Removing Separated Instruments. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Analysis of Biofilm Removal Efficacy by Multisonic Ultracleaning System and Passive Ultrasonic Activation. [2020]

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

Reporting adverse events in randomized controlled trials in periodontology: a systematic review. [2018]

7. England 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. [2021]

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

Morbidity and mortality of major adult spinal surgery. A prospective cohort analysis of 942 consecutive patients. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Dental device-associated problems: an analysis of FDA postmarket surveillance data. [2019]

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

Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

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