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

Conditions

• Pulp Necroses

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GentleWave — DEVICE
  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
• EdgePro laser irrigation — DEVICE
  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
• Irrisafe passive ultrasonic irrigation — DEVICE
  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

Study Details

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.

Key Dates

Start date

Aug 30, 2024

Status verified

Aug 2025

Primary completion

Apr 30, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: GentleWave
• Experimental: EdgePro
• Active Comparator: Irrisafe passive ultrasonic irrigation

Primary Outcome Measure

Bacterial count reduction checked by 16 S rDNA next-generation sequencing analysis (NGS) [ Time Frame: Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline) ]

Central Contacts

• David Jaramillo, DDS
  (713) 486-4224
  [email protected]
• Ahmed Shehab-Eldin
  (713) 486-4224
  [email protected]

Locations (1)

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