NCT06554366

Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars

Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars: An In-vivo Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of GentleWave versus EdgePro irrigation in the disinfection of infected root canals of human permanent teeth with necrotic pulp.

Conditions

• Pulp Necroses

Interventions

Type	Name	Description
DEVICE	GentleWave	Root canals will be shaped using a Vortex Blue and ProTaper gold rotary system. Once the root canals have been shaped, the GentleWave procedure will be performed
DEVICE	EdgePro laser irrigation	Root canals will be shaped using a Vortex Blue and ProTaper gold rotary system. Once the root canals have been shaped, the EdgePro procedure will be performed
DEVICE	Irrisafe passive ultrasonic irrigation	Root canals will be shaped using a Vortex Blue and ProTaper gold rotary system. Once the root canals have been shaped, the passive ultrasonic irrigation procedure will be performed

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2024-08-15
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study