A Study Evaluating the Sonendo GentleWave™ System

Sonendo, Inc.20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Root Canal

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sonendo

Laguna Hills, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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