What is the mechanism of action of this treatment?

The GentleWave® System and Waterlase iPlus® are advanced irrigation techniques used in root canal treatments to enhance the cleaning and disinfection of the root canal system. The GentleWave® System uses a combination of multisonic energy and fluid dynamics to remove bacteria, debris, and tissue from the entire root canal system, including the microscopic spaces that traditional methods might miss. Waterlase iPlus® employs laser energy and water to achieve similar results, effectively cleaning and shaping the root canal while minimizing damage to surrounding tissues. These advanced techniques are important for root canal patients because they increase the likelihood of a successful treatment by thoroughly disinfecting the root canal, reducing the risk of infection, and promoting better healing outcomes.

What side effects are associated with this type of intervention?

Common side effects of root canal treatments include pain, swelling, and infection at the treatment site. Advanced irrigation techniques like the GentleWave® System and Waterlase iPlus® are designed to improve the efficacy of root canal treatments and may reduce the incidence of these side effects. However, patients may still experience mild discomfort, sensitivity, or temporary inflammation following the procedure. These advanced systems aim to enhance cleaning and disinfection, potentially leading to fewer complications compared to traditional methods.

What prior FDA approvals exist?

The FDA has approved several advanced irrigation techniques for root canal treatments, including the GentleWave® System and Waterlase iPlus®. These systems aim to improve the efficacy of root canal procedures by enhancing the cleaning and disinfection of the root canal system. The GentleWave® System uses a combination of fluid dynamics and acoustic energy to remove debris and bacteria, while Waterlase iPlus® employs laser technology to achieve similar outcomes. Both systems represent significant advancements over traditional methods, offering improved clinical outcomes and patient experiences.

What other types of research exist?

Promising novel alternatives to the GentleWave® System and Waterlase iPlus® for root canal treatments include the use of laser-assisted endodontic irrigation systems, such as the PIPS (Photon-Induced Photoacoustic Streaming) and SWEEPS (Shock Wave Enhanced Emission Photoacoustic Streaming) techniques. These methods utilize laser energy to create shock waves that enhance the cleaning and disinfection of the root canal system, potentially improving treatment outcomes.

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Procedure

GentleWave vs. Waterlase for Root Canal Treatment

N/A

Waitlist Available

Led By Glenn Karunanayake, BDS, MS

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of treatment completion to 12-month follow-up appointment, assessed up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks of root canal treatments include discomfort during/after the procedure, swelling in treated area, potential damage to surrounding teeth/gums from equipment use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of treatment completion to 12-month follow-up appointment, assessed up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of treatment completion to 12-month follow-up appointment, assessed up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of treatment completion to 12-month follow-up appointment, assessed up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Periapical index score

Secondary study objectives

Qualitative data from patient and provider questionnaires about treatment procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Waterlase groupExperimental Treatment1 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 groupExperimental Treatment1 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 groupActive Control1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The GentleWave® System and Waterlase iPlus® are advanced irrigation techniques used in root canal treatments to enhance the cleaning and disinfection of the root canal system. The GentleWave® System uses a combination of multisonic energy and fluid dynamics to remove bacteria, debris, and tissue from the entire root canal system, including the microscopic spaces that traditional methods might miss. Waterlase iPlus® employs laser energy and water to achieve similar results, effectively cleaning and shaping the root canal while minimizing damage to surrounding tissues. These advanced techniques are important for root canal patients because they increase the likelihood of a successful treatment by thoroughly disinfecting the root canal, reducing the risk of infection, and promoting better healing outcomes.

Efficiency of diode laser and ultrasonic-activated irrigation in retreatment of gutta percha and bioceramic sealer: An in vitro study.