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.

NCT ID: NCT04105907

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-11-01

Brief Summary

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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

Detailed Description

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Conditions

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Root Canal Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Partial root canal treatment with the Sonendo GentleWave

Group Type EXPERIMENTAL

GentleWave

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonendo, Inc.

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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David E Jaramillo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David E Jaramillo, DDS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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David E Jaramillo, DDS

Role: CONTACT

713-486-4221

Sandra Jung

Role: CONTACT

713-486-4026

Facility Contacts

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David E Jaramillo, DDS

Role: primary

713-486-4224

Auco Dang

Role: backup

(713) 486-4258

Other Identifiers

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HSC-DB-19-0476

Identifier Type: -

Identifier Source: org_study_id

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