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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Root Canal Treatment
• Intervention / Treatment: Device: GentleWave

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David E Jaramillo, DDS; Phone Number: 713-486-4221; Email: David.E.Jaramillo@uth.tmc.edu
• Study Contact Backup: Name: Sandra Jung; Phone Number: 713-486-4026; Email: Sandra.Jung@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Auco Dang; Phone Number: (713) 486-4258; Email: Auco.Dang@uth.tmc.edu
      • Contact: David E Jaramillo, DDS; Phone Number: 713-486-4224; Email: David.E.Jaramillo@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Teeth with root fractures or previously root canal treated teeth.
• Teeth with severe loss of structure
• Children

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partial root canal treatment with the Sonendo GentleWave	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Sonendo, Inc.
• Investigators: Principal Investigator: David E Jaramillo, DDS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: GentleWave; Multisonication; Sonendo
• Other Study ID Numbers: HSC-DB-19-0476

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