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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.

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.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04105907
Enrollment
50
Registered
2019-09-26
Start date
2025-11-01
Completion date
2026-11-01
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root Canal Treatment

Keywords

GentleWave, Multisonication, Sonendo

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

Interventions

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

Sonendo, Inc.
CollaboratorINDUSTRY
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visualization of the amount of pulp tissue left behind after GentleWave procedureat 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

MeasureTime 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 microscopeat the time of tooth extraction(immediately after GentleWave procedure)

Countries

United States

Contacts

Primary ContactDavid E Jaramillo, DDS
David.E.Jaramillo@uth.tmc.edu713-486-4221
Backup ContactSandra Jung
Sandra.Jung@uth.tmc.edu713-486-4026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026