A Study Evaluating the Sonendo GentleWave™ System
Terminated
- Conditions
- Root Canal
- Registration Number
- NCT02478723
- Lead Sponsor
- Sonendo, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subject teeth that are healed or are healing at the twenty-four month follow-up visit. 24 months Healed is defined by absence of a radiographic indication of apical periodontitis (Periapical Index Score \< 3) and absence of clinical signs and symptoms.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sonendo
🇺🇸Laguna Hills, California, United States