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Recruiting NCT06554366

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

No phase Interventional Pulp Necroses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GentleWave, EdgePro laser irrigation, Irrisafe passive ultrasonic irrigation.
Who it may be relevant to
Registry conditions: Pulp Necroses. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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)]
Secondary outcome measures (1)
  • Presence of proteolytic versus non-proteolytic bacteria in the root canals [Time frame: Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06554366 · HSC-DB-24-0062

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗