A Study Evaluating the Sonendo GentleWave™ System (To The Point)

April 2, 2019 updated by: Sonendo, Inc.

An Observational Study Evaluating the Sonendo GentleWave™ System and the EndoTechnologies CPoint™ Obturation for Treatment of Molar Teeth Requiring Root Canal Therapy

A post market, observational study evaluating the treatment of 1st and 2nd molars indicated for root canal therapy and treated with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Sonendo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years of age or older, who have a 1st or 2nd molar tooth that received root canal therapy with the Sonendo GentleWave System and obturation with CPoint and BC Sealer in at least one canal.

Description

Inclusion Criteria:

  • The patient is 18 years of age or older
  • The subject tooth has been treated for root canal therapy with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal
  • The subject tooth is a 1st or 2nd molar

Exclusion Criteria:

  • Vertical fracture, horizontal fracture, or perforation extending below the Cemento-Enamel Junction (CEJ) of the subject tooth
  • Subject tooth having previous or attempted pulpectomy or root canal therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject teeth that are healed or are healing at the twenty-four month follow-up visit.
Time Frame: 24 months
Healed is defined by absence of a radiographic indication of apical periodontitis (Periapical Index Score < 3) and absence of clinical signs and symptoms.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonendo, Inc.

Investigators

  • Study Director: Dan Miller, Sonendo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

January 24, 2018

Study Completion (Actual)

March 27, 2019

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CS-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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