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.
NCT04105907 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-09-12
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
Conditions
- Root Canal Treatment
Interventions
- DEVICE
-
GentleWave
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
Sponsors & Collaborators
-
Sonendo, Inc.
collaborator INDUSTRY -
The University of Texas Health Science Center, Houston
lead OTHER
Principal Investigators
-
David E Jaramillo, DDS · The University of Texas Health Science Center, Houston
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-01
- Primary Completion
- 2026-11-01
- Completion
- 2026-11-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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