Root Canal
Conditions
Keywords
requiring therapy, Teeth
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.
Interventions
The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
Sponsors
Sonendo, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed