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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new techniques, GentleWave and Waterlase, to determine if they outperform the usual method for root canal treatment. Researchers aim to discover if these techniques improve healing in cases of infections or bone loss around the tooth root. Participants will receive either one of the new treatments or the usual one and will be monitored for a year to assess tooth healing. Suitable candidates have a permanent tooth needing a root canal and show signs of tooth nerve problems or bone loss on X-rays. As an unphased trial, this study allows participants to contribute to innovative dental research and potentially benefit from advanced treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies showed that the GentleWave System had a 97.3% success rate in treating root canals, with healing rates over 97% at 6 and 12 months. Patients experienced short-term pain levels similar to traditional methods, indicating good tolerance.

Research shows that the Waterlase iPlus effectively cleans and disinfects root canals. It uses laser technology to fight infections, providing dentists with better control during the procedure.

Both treatments are promising, with high success rates and manageable pain levels, suggesting they are safe options for root canal treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the GentleWave System and Waterlase iPlus for root canal treatments because they offer innovative approaches to endodontic irrigation. Unlike traditional methods that often rely on manual techniques, the GentleWave System uses advanced acoustic energy to clean and disinfect the root canal system more thoroughly, potentially leading to better long-term healing. On the other hand, Waterlase iPlus employs laser technology, which not only aids in cleaning but also minimizes discomfort and accelerates the healing process. These cutting-edge technologies could significantly enhance the effectiveness and patient experience compared to the conventional treatments like passive ultrasonic irrigation.

What evidence suggests that the GentleWave System and Waterlase iPlus are effective for root canal treatment?

In this trial, participants will receive either the GentleWave System or Waterlase iPlus for root canal treatments. Research has shown that the GentleWave System is highly effective, with a success rate of over 97%, and typically causes less discomfort during and after the procedure. This system excels at cleaning root canals, promoting faster healing. Meanwhile, studies on Waterlase iPlus have demonstrated its effectiveness in reducing bacteria and debris in the root canal. This laser treatment cleans deeply and lessens the need for strong chemicals. Both treatments offer promising alternatives to traditional methods, aiming for better results and increased comfort. ^{1 2 4 6 7}

Who Is on the Research Team?

Glenn Karunanayake, BDS, MS

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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 (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]

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. jendodon.com jendodon.com/article/S0099-2399(25)00649-1/fulltext

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41167331/

Clinical and Laboratory Insights into the GentleWave System Results: A total of 34 studies met the inclusion criteria, including 28 laboratory-based investigations (82.4%) and 6 clinical studies (17.6%).

4. mtnviewendo.com mtnviewendo.com/revolutionizing-root-canal-therapy-the-gentlewave-system/

Outcomes of the GentleWave System on Root Canal ... Improved Comfort: The GentleWave system is often associated with less discomfort during and after the procedure. · Enhanced Cleaning: The system's ability to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06518304

Effectiveness of GentleWave System in Endodontic ... This study aims to evaluate the efficacy of the GentleWave® System compared to conventional methods in reducing postoperative pain in patients with necrotic ...

6. gentlewave.com gentlewave.com/

The GentleWave® Procedure: The Root Canal Treatment That ... The GentleWave® Procedure is a root canal therapy option and is considered a medical procedure with potential adverse effects. Consultation with a dental ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35284323/

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 ...