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.

Root Canal Treatment Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04105907
• Other study ID #: HSC-DB-19-0476
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: November 1, 2026

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: David E Jaramillo, DDS
• Phone: 713-486-4221
• Email: David.E.Jaramillo[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Root Canal Treatment

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Sonendo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)