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.

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT04105907
Status
Not Yet Recruiting

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Conditions

  • Root Canal Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Nov 1, 2025
Status verified
Sep 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Partial root canal treatment with the Sonendo GentleWave

Primary Outcome Measure

Visualization of the amount of pulp tissue left behind after GentleWave procedure [ Time Frame: at the time of tooth extraction(immediately after GentleWave procedure) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
David E Jaramillo, DDS
[email protected]
713-486-4224
Auco Dang
[email protected]
(713) 486-4258

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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