NCT02478723

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2019

Completed
Last Updated

April 4, 2019

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

June 17, 2015

Last Update Submit

April 2, 2019

Conditions

Root Canal

Keywords

requiring therapyTeeth

Outcome Measures

Primary Outcomes (1)

  • Subject teeth that are healed or are healing at the twenty-four month follow-up visit.

    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

Interventions

Sonendo GentleWave™ SystemDEVICE

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

Also known as: EndoTechnologies CPoint™ Obturation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonendo

Laguna Hills, California, 92653, United States

Location

Study Officials

  • Dan Miller

    Sonendo, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 23, 2015

Study Start

April 1, 2015

Primary Completion

January 24, 2018

Study Completion

March 27, 2019

Last Updated

April 4, 2019

Record last verified: 2019-03

Locations

US(1)