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TerminatedNCT02478723To The PointUpdated Apr 4, 2019

A Study Evaluating the Sonendo GentleWave™ System

An observational study in Root Canal, sponsored by Sonendo, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-04.

Sponsored by Sonendo, Inc. · Observational

Why this study was terminated
Study device no longer manufactured by Sonendo. Total enrollment for the study was 20 subjects, only 3 subjects were enrolled and treated.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Root Canal

Keywords

  • requiring therapy
  • Teeth
03

In context

Lead sponsor

Sonendo, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • DeviceSonendo GentleWave™ System

    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

06

What researchers measure

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.

    Time frame: 24 months

07

Study locations

1 site
  • Sonendo
    Laguna Hills, California 92653, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02478723
Lead sponsor
Sonendo, Inc.
Responsible party
Sponsor
First posted
Jun 23, 2015
Start date
Apr 2015
Primary completion
Jan 24, 2018
Completion
Mar 27, 2019
Last update
Apr 4, 2019

Study contacts

Dan Miller
study director · Sonendo, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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