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Comparison of Clinical Outcomes Between GentleWave® and Biolase®

NCT05555043 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-08-12

No results posted yet for this study

Summary

Introduction: In the US, 15 million root canal treatments (RCTs) are carried out annually. Success rates decrease with conventional chemo-mechanical root canal preparation techniques used on teeth with periapical radiolucencies associated with bacterial presence. New irrigation modalities, such as the GentleWave® System (GWS) and Waterlase iPlus® (WL), have been developed to overcome limitations and improve RCT success rates.

Hypotheses: (1) GWS and WL provide superior clinical outcomes compared to conventional RCT using passive ultrasonic activation (PUI). (2) GWS and WL are acceptable treatment modalities for clinicians and patients.

Aims: (1) Estimate probability of success of GWS, WL, and conventional RCT with PUI. (2) Evaluate clinician and patient experiences of the different techniques.

Conditions

  • Endodontic Disease
  • Periapical Diseases
  • Periapical Periodontitis
  • Root Canal Infection

Interventions

DEVICE

Irrisafe ip

This portion of endodontic treatment includes chemical disinfection of the root canal system with these different devices that activate the disinfection solution and distribute it throughout the root canal system with ultrasonic energy.

DEVICE

GentleWave System

Prepare, clean and irrigate root canals including activation of the disinfection solution and distribution throughout the root canal system.

DEVICE

Waterlase iPlus

Prepare tooth and root canal, including enlargement, to debride, clean and disinfect after endodontic treatment.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Glenn Karunanayake, BDS, MS · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2025-07-25
Completion
2025-07-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555043 on ClinicalTrials.gov