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

The University of Texas System (UT)

Status: Enrolling

Conditions: Pulp Necroses

Treatments: Device: GentleWave; Device: Irrisafe passive ultrasonic irrigation; Device: EdgePro laser irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06554366

HSC-DB-24-0062

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Permanent teeth that are diagnosed with pulp necrosis.
• elected to have a permanent tooth nonsurgical root canal treatment
• Signed informed consent.

Exclusion criteria

• Teeth with root fractures or previously root canal treated teeth.
• Teeth with severe loss of structure
• Teeth with vital pulps.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

GentleWave

Experimental group

Treatment:

Device: GentleWave

EdgePro

Experimental group

Treatment:

Device: EdgePro laser irrigation

Irrisafe passive ultrasonic irrigation

Active Comparator group

Treatment:

Device: Irrisafe passive ultrasonic irrigation