GentleWave vs. Waterlase for Root Canal Treatment

Overseen By Glenn A Karunanayake, BDS, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Heart disease, Lung disease, Bleeding disorders, 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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two new methods, GentleWave® System and Waterlase iPlus®, for cleaning root canals. These methods use sound waves and lasers to clean teeth more effectively than traditional techniques. The trial targets patients with difficult-to-treat root canal infections to see if these new methods improve treatment success. The GentleWave® System has been shown to result in a higher tissue dissolution rate and is effective against harmful substances in infected root canals.

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

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

Research shows that the GentleWave System is effective in cleaning root canals, with a high success rate of 97.3% for endodontic treatment. It also removes more bacteria and debris compared to traditional methods, which can help prevent infections. ^{1 2 3 4 5}

Is the GentleWave System safe for root canal treatment?

The GentleWave System has been studied in clinical trials and reviews, showing a high success rate for root canal treatments and no significant difference in short-term postoperative pain compared to conventional methods, suggesting it is generally safe for use in humans. ^{1 2 3 5 6}

How does the GentleWave System differ from other treatments for root canal cleaning?

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 bacteria and tissue debris. ^{1 2 3 5 6}

Research Team

Glenn Karunanayake, BDS, MS

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for males and females aged 14-99 with a permanent tooth needing root canal treatment due to pulp disease or infection, who can consent to the procedure. It's not for those with teeth that can't be restored, have high mobility or deep periodontal pockets, fractures, open apices, certain anatomical challenges, need multiple RCTs, allergies to anesthetics or severe systemic diseases.

Inclusion Criteria

I have severe tooth pain or infection and bone loss around the tooth root.

I need a root canal on a tooth that can be saved.

Patient-signed informed consent/assent form

Exclusion Criteria

I am not allergic to anesthetics and do not have heart, lung diseases, bleeding disorders, or immune deficiencies.

Subject tooth has insufficient tooth structure to create GWS platform

I have a tooth with an open or incomplete root.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive endodontic treatment using either GentleWave, Waterlase, or passive ultrasonic irrigation. Treatment may be completed in one or two appointments.

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for clinical and radiographic healing of periapical lesions over 12 months.

12 months

1 visit (in-person)

Treatment Details

Interventions

• GentleWave System
• Waterlase iPlus

Trial Overview The study compares new root canal irrigation methods: GentleWave System (GWS) and Waterlase iPlus (WL), against conventional passive ultrasonic activation (PUI). It aims to see which method gives better results and how patients and clinicians feel about them.

Participant Groups

Group I: Waterlase group Experimental Treatment 1 Intervention

Participants receive Waterlase iPlus for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth.

Group II: GentleWave group Experimental Treatment 1 Intervention

Participants receive GentleWave System for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth.

Group III: Control group Active Control 1 Intervention

Participants receive passive ultrasonic irrigation for endodontic irrigation treatment and will be followed for 12 months after treatment to assess radiographic healing of the periapex and clinical healing of the tooth.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

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]

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]

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 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]

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. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of Photon-Induced Photoacoustic Streaming (PIPS) on Root Canal Disinfection and Post-Operative Pain: A Randomized Clinical Trial. [2020]

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

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

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

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