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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06554366
Enrollment
30
Registered
2024-08-15
Start date
2024-08-30
Completion date
2026-04-30
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulp Necroses

Keywords

Root canal

Brief 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.

Interventions

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

DEVICEEdgePro 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

DEVICEIrrisafe 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

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Presence of proteolytic versus non-proteolytic bacteria in the root canalsBaseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)

Countries

United States

Contacts

Primary ContactDavid Jaramillo, DDS
David.E.Jaramillo@uth.tmc.edu(713) 486-4224
Backup ContactAhmed Shehab-Eldin
Ahmed.ShehabEldin@uth.tmc.edu(713) 486-4224

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026