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NCT Number: NCT04105907

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

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Key information

Conditions

Root Canal Treatment

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GentleWave

Device

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

Primary outcomes

  1. Visualization of the amount of pulp tissue left behind after GentleWave procedure

    Time frame: at the time of tooth extraction(immediately 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

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

    Time frame: at the time of tooth extraction(immediately after GentleWave procedure)

Study contacts

Contact information is provided by the study sponsor or research team.

David E Jaramillo, DDS

CONTACT

[email protected]

713-486-4221

Sandra Jung

CONTACT

[email protected]

713-486-4026

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Sonendo, Inc.

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2019
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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