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Study device no longer manufactured by Sonendo. Total enrollment for the study was 20 subjects, only 3 subjects were enrolled and treated.
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonendo GentleWave™ System | Device | The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dan Miller | Sonendo, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonendo | Laguna Hills | California | 92653 | United States |
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