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NCT Number: NCT06554366

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

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.

Recruiting

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Key information

Conditions

Pulp Necroses Dental Pulp Diseases Dental Pulp Necrosis Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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 outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Shehab-Eldin

CONTACT

[email protected]

(713) 486-4224

David Jaramillo, DDS

CONTACT

[email protected]

(713) 486-4224

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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