Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2024
CompletedFirst Posted
Study publicly available on registry
August 15, 2024
CompletedStudy Start
First participant enrolled
August 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedSeptember 5, 2025
August 1, 2025
1.7 years
August 12, 2024
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Presence of proteolytic versus non-proteolytic bacteria in the root canals
Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
Study Arms (3)
GentleWave
EXPERIMENTALEdgePro
EXPERIMENTALIrrisafe passive ultrasonic irrigation
ACTIVE COMPARATORInterventions
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
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
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
Eligibility Criteria
You may qualify if:
- Permanent teeth that are diagnosed with pulp necrosis.
- elected to have a permanent tooth nonsurgical root canal treatment
- Signed informed consent.
You may not qualify if:
- Teeth with root fractures or previously root canal treated teeth.
- Teeth with severe loss of structure
- Teeth with vital pulps.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Jaramillo, DDS
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 12, 2024
First Posted
August 15, 2024
Study Start
August 30, 2024
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
September 5, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share