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Sonendo GentleWave™ System ...

Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy

Last Updated: 2023-01-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-12-31

Brief Summary

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A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.

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Detailed Description

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A prospective, non-significant risk device, literature controlled, study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.

All patients will receive root canal therapy with the Sonendo GentleWave System. All patients will be followed for 24 months post procedure.

Conditions

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Root Canal Therapy

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sonendo GentleWave™ System

The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.

Group Type OTHER

Sonendo GentleWave™ System

Intervention Type DEVICE

Interventions

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Sonendo GentleWave™ System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 to 75 years of age
* Indicated for root canal therapy
* First or second molar
* Signed informed consent form

Exclusion Criteria

* Poor oral hygiene
* Class II or III mobility
* Open or incompletely formed root apices
* Vertical fracture, horizontal fracture, or perforation below the Cemento-Enamel Junction (CEJ)
* Previous pulpectomy or root canal therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Miller

Role: STUDY_DIRECTOR

Sonendo, Inc.

Locations

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Shahriar Rassoulian, DMD

Aliso Viejo, California, United States

Site Status

Khang Le, DDS

Santa Ana, California, United States

Site Status

Stacey Woo, DDS

Whittier, California, United States

Site Status

Countries

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United States

References

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Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CS-06

Identifier Type: -

Identifier Source: org_study_id

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Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy

Study Results

Basic Information

Brief Summary

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Detailed Description

Conditions

Study Design

Study Groups

Sonendo GentleWave™ System

Sonendo GentleWave™ System

Interventions

Sonendo GentleWave™ System

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Sonendo, Inc.

Responsible Party

Principal Investigators

Dan Miller

Locations

Shahriar Rassoulian, DMD

Khang Le, DDS

Stacey Woo, DDS

Countries

References

Peters OA, Schonenberger K, Laib A. Effects of four Ni-Ti preparation techniques on root canal geometry assessed by micro computed tomography. Int Endod J. 2001 Apr;34(3):221-30. doi: 10.1046/j.1365-2591.2001.00373.x.

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