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Comparison of Clinical Outcomes Between GentleWave® and Biolase®
Sponsor: University of North Carolina, Chapel Hill
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.
Official title: Comparison of Clinical Outcomes Between GentleWave® and Biolase®: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
14 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2022-11-08
Completion Date
2025-07-25
Last Updated
2026-08-19
Healthy Volunteers
Yes
Interventions
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.
GentleWave System
Prepare, clean and irrigate root canals including activation of the disinfection solution and distribution throughout the root canal system.
Waterlase iPlus
Prepare tooth and root canal, including enlargement, to debride, clean and disinfect after endodontic treatment.
Locations (1)
Univeristy of North Carolina Adams School of Dentistry
Chapel Hill, North Carolina, United States