Overview

This trial is active, not recruiting.

Condition root canal
Treatment sonendo gentlewave™ system
Sponsor Sonendo, Inc.
Start date April 2015
End date April 2017
Trial size 20 participants
Trial identifier NCT02478723, CS-08

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Subject teeth that are healed or are healing at the twenty-four month follow-up visit.
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Observational Study Evaluating the Sonendo GentleWave™ System and the EndoTechnologies CPoint™ Obturation for Treatment of Molar Teeth Requiring Root Canal Therapy
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sonendo, Inc..