N/A
N=69
Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy
Root Canal Therapy
Bottom Line
View on ClinicalTrials.gov: NCT02285595 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5 — 51; 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sonendo GentleWave™ System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sonendo, Inc.
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5 |
51; 3; 0 | — |
| PRIMARY Periradicular Diagnosis |
40; 0; 0; 0; 0; 0 | — |
Summary
A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.
Eligibility Criteria
Inclusion Criteria
- 18 to 75 years of age
- Indicated for root canal therapy
- First or second molar
- Signed informed consent form
Exclusion Criteria
- Poor oral hygiene
- Class II or III mobility
- Open or incompletely formed root apices
- Vertical fracture, horizontal fracture, or perforation below the Cemento-Enamel Junction (CEJ)
- Previous pulpectomy or root canal therapy
Note: Additional exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02285595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.