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

September 4, 2025 updated by: David E Jaramillo, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GentleWave
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
Experimental: EdgePro
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
Active Comparator: Irrisafe passive ultrasonic irrigation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: David Jaramillo, DDS, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-DB-24-0062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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