NCT02557152

Brief Summary

The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage. The registry population includes up to 500 subjects that have been treated with the Sonendo GentleWave System at up to 25 clinical sites in the United States.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

September 21, 2015

Last Update Submit

April 2, 2019

Conditions

Root Canal

Outcome Measures

Primary Outcomes (1)

  • Healing

    Radiographic analysis and clinical signs and symptoms at 24 months

    24 months

Secondary Outcomes (1)

  • Retreatment Rates

    24 months

Study Arms (1)

Patients that were treated with the GentleWave System

Device: GentleWave System Treatment

Interventions

GentleWave System TreatmentDEVICE
Patients that were treated with the GentleWave System

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to 500 subjects that have been treated with the Sonendo GentleWave System.

You may qualify if:

  • One or more teeth treated with the Sonendo GentleWave System

You may not qualify if:

  • Institutionalized patients or prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Randy Garland, DDS

Encinitas, California, United States

Location

SC Endododontics

Santa Ana, California, United States

Location

Stacey Woo, DDS

Whittier, California, United States

Location

Study Officials

  • Kim Bradbury

    Sonendo, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 23, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

US(3)