Histological Evaluation in the Efficacy of GentleWave in Root Canal Pulp Tissue Debridement and Disinfection of Difficult to Reach Areas in Mandibular Human Molars II. An In-vivo Study.
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to understand and learn better the efficacy of GentleWave and obtain histological evidence of the efficacy of this new technology done in-vivo
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
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
September 24, 2019
CompletedFirst Posted
Study publicly available on registry
September 26, 2019
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
September 12, 2025
September 1, 2025
1 year
September 24, 2019
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visualization of the amount of pulp tissue left behind after GentleWave procedure
Visualization of the amount of pulp tissue left behind after GentleWave procedure as assessed by reviewing the histological serial sections under the light microscope
at the time of tooth extraction(immediately after GentleWave procedure)
Secondary Outcomes (1)
Number of participants with the presence of bacteria inside the root canal and inside the dentinal tubules as assessed by observation under the light microscope
at the time of tooth extraction(immediately after GentleWave procedure)
Study Arms (1)
Partial root canal treatment with the Sonendo GentleWave
EXPERIMENTALInterventions
Subject teeth will receive a partial root canal treatment with the Sonendo GentleWave system followed by extraction of the tooth and histological evaluation of the tooth
Eligibility Criteria
You may qualify if:
- Only teeth that patient decided to have the extraction done instead of having any other type of dental treatment and teeth extracted at patient's petition.
You may not qualify if:
- Teeth with root fractures or previously root canal treated teeth.
- Teeth with severe loss of structure
- Children
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
Study Officials
- PRINCIPAL INVESTIGATOR
David E Jaramillo, DDS
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 24, 2019
First Posted
September 26, 2019
Study Start
November 1, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share