A Study Evaluating the Sonendo GentleWave™ System

Root Canal Clinical Trial

— To The Point  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02478723
• Other study ID #: CS-08
• Status: Terminated
• Start date: April 2015
• Est. completion date: March 27, 2019

Study information

• Verified date: March 2019
• Source: Sonendo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 27, 2019
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Root Canal

Intervention

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

Locations

Country	Name	City	State
United States	Sonendo	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Sonendo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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