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COMPLETED
NCT05555043
NA

Comparison of Clinical Outcomes Between GentleWave® and Biolase®

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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

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.

Locations (1)

Univeristy of North Carolina Adams School of Dentistry

Chapel Hill, North Carolina, United States