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

April 2, 2019 updated by: Sonendo, Inc.

A Prospective, Multicenter Study Comparing Healing After Treatment With the Sonendo GentleWave™ System as Compared to a Traditional Root Canal Therapy Literature Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

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
      • Aliso Viejo, California, United States
        • Shahriar Rassoulian, DMD
      • Santa Ana, California, United States
        • Khang Le, DDS
      • Whittier, California, United States
        • Stacey Woo, DDS

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Note: Additional exclusion criteria may apply.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sonendo GentleWave™ System
The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
Device: Sonendo GentleWave™ System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject teeth that are healed or healing at the 12 month follow-up visit.
Time Frame: 12 months

Healed is defined by absence of a radiographic indication of apical periodontitis (PAI <3) and absence of clinical signs and symptoms other than tenderness to percussion.

Healing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.
12 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)

July 1, 2014

Primary Completion (Actual)

June 22, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CS-06

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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